Recall events
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Event 83386
Event summary
Timeline bucket July 03, 2019
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Valeritas, Incorporated
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
5 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 5
DEMO No Needle Corrugated Carton 20 U/D, Part Number 2260-03
Z-0195-2020
Recall number Z-0195-2020
Initiated July 03, 2019
Classification Class II
Status Terminated
Quantity 49,074 devices
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential for "No Needle Demo Units" to contain a needle.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Employee error
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0195-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11029]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential for "No Needle Demo Units" to contain a needle.
Code information UDI: (01)10385609020039(17)XXXXXX(10)XXXXXXXX Lot Numbers: DM218001 DM218002 DM218003 DM218004 DM218005 DM218006 DM218020 DM218025 DM218034 DM218035 DM218036
Distribution pattern Nationwide within U.S.
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[9886]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 5
DEMO No Needle Corrugated Carton 30 U/D, Part Number 2260-02
Z-0196-2020
Recall number Z-0196-2020
Initiated July 03, 2019
Classification Class II
Status Terminated
Quantity 20,532 devices
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential for "No Needle Demo Units" to contain a needle.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Employee error
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0196-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33160]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential for "No Needle Demo Units" to contain a needle.
Code information UDI: (01)10385609020022(17)XXXXXX(10)XXXXXXXX Lot Numbers: DM318007 DM318008 DM318009 DM318010 DM318026
Distribution pattern Nationwide within U.S.
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[11338]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 5
DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01
Z-0197-2020
Recall number Z-0197-2020
Initiated July 03, 2019
Classification Class II
Status Terminated
Quantity 21,714 devices
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential for "No Needle Demo Units" to contain a needle.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Employee error
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0197-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27843]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential for "No Needle Demo Units" to contain a needle.
Code information UDI: (01)10385609020015(17)XXXXXX(10)XXXXXXXX Lot Numbers: DM418011 DM418012 DM418013 DM418014 DM418015 DM418016 DM418017 DM418031 DM418033 DM418037
Distribution pattern Nationwide within U.S.
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[11318]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 5
DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03
Z-0198-2020
Recall number Z-0198-2020
Initiated July 03, 2019
Classification Class II
Status Terminated
Quantity 852 devices
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential for "No Needle Demo Units" to contain a needle.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Employee error
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0198-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[39471]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential for "No Needle Demo Units" to contain a needle.
Code information UDI: (01)10385609021039(17)XXXXXX(10)XXXXXXXX Lot Number: DM218024
Distribution pattern Nationwide within U.S.
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[8742]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 5
DEMO No Needle Corrugated Carton 30 U/D, Part Number 2568-02
Z-0199-2020
Recall number Z-0199-2020
Initiated July 03, 2019
Classification Class II
Status Terminated
Quantity 60 devices
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential for "No Needle Demo Units" to contain a needle.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Employee error
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0199-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11026]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential for "No Needle Demo Units" to contain a needle.
Code information UDI: (01)10385609021022(17)XXXXXX(10)XXXXXXXX Lot Number: DM318022
Distribution pattern Nationwide within U.S.
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[7611]
FDA event record
· Exact recall-number query on openFDA
