Recall events
/
Event 97896
Event summary
Timeline bucket November 03, 2025
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording GET TESTED INTERNATIONAL AB
Dossier provenance
Source snapshots represented here
openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Complete imported group
Every recalled product in this event
92 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 92
Alcohol (ALC) Test Saliva
Z-0727-2026
Recall number Z-0727-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 1 unit
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0727-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17545]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221708884; SKU: A-ALC-S; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1599]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 92
Blood Type Test
Z-0728-2026
Recall number Z-0728-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 47 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0728-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[29521]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221708136; SKU: A-BG; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1548]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 92
Candida Test
Z-0729-2026
Recall number Z-0729-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 166 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0729-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56107]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221700888; SKU: B-CAN; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1810]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 92
Chlamydia Test
Z-0730-2026
Recall number Z-0730-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 5 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0730-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[35264]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221701663; SKU: A-ICH; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1878]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 92
D-Dimer Test
Z-0731-2026
Recall number Z-0731-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 1218 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0731-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[23387]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221700475; SKU: A-CDM; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1627]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 92
Diabetes HbA1c Test
Z-0732-2026
Recall number Z-0732-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 148 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0732-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11750]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221707191; SKU: A-HbA1c; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1801]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 92
Illegally Marketed
Z-0733-2026
Recall number Z-0733-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 1 unit
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0733-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[23380]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221701083; SKU: A-DR12; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1800]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 92
Drug Test Small (4 substances)
Z-0734-2026
Recall number Z-0734-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 1 unit
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0734-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17544]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221701045; SKU: A-DR4; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[2013]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 92
Epstein-Barr Virus (EBV VCA & EBNA IgG) Test
Z-0735-2026
Recall number Z-0735-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 4081 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0735-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46564]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221708211; SKU: A-EBV; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1886]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0736-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 35 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0736-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46573]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221700642; SKU: A-FOB; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1686]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0737-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 31 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0737-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[41030]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221707139; SKU: A-AMH; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1958]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0738-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 463 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0738-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5719]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221701533; SKU: A-IGO; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[2021]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0739-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 239 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0739-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[29191]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221700604; SKU: A-PYL; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1670]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0740-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 1361 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0740-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[29203]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221710047; SKU: A-HSV; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1661]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0741-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 258 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0741-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11749]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221708259; SKU: A-HPV; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1936]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0742-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 5187 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0742-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[35254]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221700840; SKU: A-FER; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1864]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0743-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 940 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0743-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[35256]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221700468; SKU: A-ILY; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1707]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0744-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 184 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0744-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46571]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221700437; SKU: A-FSH; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1547]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0745-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 4 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0745-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17543]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221708976; SKU: A-MPVAR; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1625]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0746-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 23 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0746-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[29662]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221710030; SKU: A-MYC; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1646]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0747-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 128 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0747-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56109]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221700451; SKU: A-LH; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[2039]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0748-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 658 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0748-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11747]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221707153; SKU: A-PARA; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1826]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0749-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 2 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0749-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5853]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221700697; SKU: A-HCG; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1895]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0750-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 33 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0750-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[29202]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221700444; SKU: A-SPE; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1754]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0751-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 528 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0751-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56105]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221701656; SKU: A-ISY; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1819]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0752-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 1916 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0752-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[35257]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221700567; SKU: A-TSH; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1660]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0753-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 60 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0753-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5852]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221707245; SKU: A-ITV; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1611]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0754-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 40 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0754-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[41040]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221700529; SKU: A-URI; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1624]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0755-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 31 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0755-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[41037]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221700680; SKU: A-PHV; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1745]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0756-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 1557 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0756-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11748]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221700802; SKU: A-VID; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1486]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0757-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 1 unit
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0757-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46566]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221710221; SKU: VAN-SPE; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1644]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0758-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 1 unit
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0758-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56106]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221709331; SKU: UEP; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1696]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0759-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 3 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0759-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5723]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221709157; SKU: U44; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1635]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0760-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 3 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0760-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46562]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221709188; SKU: U240; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1848]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0761-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 1 unit
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0761-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17548]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221709171; SKU: U144; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1564]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0762-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 3 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0762-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[35255]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221709164; SKU: U96; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1651]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0763-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 1 unit
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0763-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[29192]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221709195; SKU: UGS; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1634]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0764-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 3 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0764-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[35261]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221709225; SKU: UGXL; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1586]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0765-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 2 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0765-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56110]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221709300; SKU: UMT; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1495]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0766-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 36 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0766-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[29198]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221709270; SKU: UNAD; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1645]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0767-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 1 unit
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0767-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11746]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221709263; SKU: UOAL; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1628]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0768-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 10 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0768-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[23388]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221709232; SKU: UD; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1967]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0769-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 71 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0769-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[35263]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221707221; SKU: HT-IgE; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1792]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0770-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 4 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0770-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[29199]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221708952; SKU: CGM-15D; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1913]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0771-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 80 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0771-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[29188]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221704459; SKU: DFI-CHT01; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1659]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0772-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 17 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0772-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5726]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221708488; SKU: 2O320-1CO; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1818]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0773-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 24 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0773-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[41026]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612787187; SKU: 2A171; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1606]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0774-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 3 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0774-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17754]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612786210; SKU: H612; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1555]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0775-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 109 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0775-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46559]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612785916; SKU: 2A120; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1579]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0776-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 17 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0776-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[23381]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612786418; SKU: O320; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1832]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0777-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 8 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0777-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5720]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612787323; SKU: 2B120; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1503]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0778-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 3 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0778-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[35258]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612785893; SKU: A130; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1871]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0779-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 3 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0779-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11745]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612785886; SKU: 2A111; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1596]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0780-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 2 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0780-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[23382]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612786944; SKU: 2A713BWG-A500; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1863]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0781-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 6 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0781-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[29205]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612785879; SKU: 2A110; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1605]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0782-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 4 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0782-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[23383]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612785909; SKU: A020; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1617]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0783-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 19 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0783-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56104]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612786074; SKU: E190; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1730]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0784-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 8 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0784-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[41036]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612785930; SKU: IBS; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1591]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0785-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 45 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0785-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46563]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612785978; SKU: 2A169; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1512]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0786-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 15 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0786-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56103]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612785978; SKU: B110; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1492]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0787-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 31 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0787-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[35262]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612785923; SKU: A500; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1985]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0788-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 10 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0788-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5721]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612787002; SKU: O934; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1583]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0789-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 18 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0789-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56112]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612786432; SKU: F500; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1677]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0790-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 18 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0790-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17549]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612786449; SKU: F510; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1825]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0791-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 14 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0791-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[23386]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612786968; SKU: F620; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1687]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0792-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 4 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0792-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46560]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612786951; SKU: E408; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1722]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0793-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 94 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0793-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[52754]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612786425; SKU: 2A178; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1809]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0794-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 12 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0794-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[41032]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612787309; SKU: 2-B220; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1530]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0795-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 27 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0795-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17551]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612787316; SKU: G670D; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1785]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0796-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 55 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0796-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11751]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612785947; SKU: B105; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1538]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0797-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 1 unit
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0797-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56101]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612787330; SKU: 2-B130; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1685]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0798-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 37 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0798-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[29204]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612786999; SKU: O935; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1678]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0799-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 48 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0799-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[29187]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221701717; SKU: D-DIA; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1669]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0800-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 100 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0800-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5977]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221701731; SKU: D-KID; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1668]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0801-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 488 months
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0801-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[23537]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221701724; SKU: D-LIV; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[2027]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0802-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 16 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0802-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11842]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612785497; SKU: 1B2; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1671]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0803-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 19 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0803-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17541]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612785503; SKU: 1000; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1943]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0804-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 76 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0804-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46576]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612785602; SKU: 1CO; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1578]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0805-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 9 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0805-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17753]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612785763; SKU: 1OS; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1905]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0806-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 6 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0806-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[29201]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612785640; SKU: 1G2; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1643]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0807-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 16 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0807-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[35253]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612785633; SKU: 1B3; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1496]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0808-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 5 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0808-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17546]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612785626; SKU: 1G1; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1485]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0809-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 50 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0809-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[41038]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612785749; SKU: 1SM; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1688]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0810-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 13 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0810-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[41222]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612785572; SKU: 1JO; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1521]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0811-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 115 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0811-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5724]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612785589; SKU: 1FE; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1570]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0812-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 12 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0812-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[52755]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612785657; SKU: 1ML; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1694]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0813-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 29 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0813-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46575]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612785695; SKU: TI; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1594]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0814-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 10 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0814-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11752]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612785688; SKU: 1EP; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1763]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0815-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 12 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0815-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[29197]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 616612785718; SKU: 1SE; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1841]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0816-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 754 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0816-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56108]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221700925; SKU: B-TOG; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1995]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0817-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 1210 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0817-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5722]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221704770; SKU: JD-3STI; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1652]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0818-2026
Initiated November 03, 2025
Classification Class II
Status Ongoing
Quantity 2043 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Distribution without premarket approval/clearance.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0818-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56100]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Distribution without premarket approval/clearance.
Code information EAN: 7340221704794; SKU: JD-8STI; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1793]
FDA event record
· Exact recall-number query on openFDA
