Recall events
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Event 87993
Event summary
Timeline bucket May 26, 2021
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Edwards Lifesciences, LLC
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
8 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 8
Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691954507
Z-1959-2021
Recall number Z-1959-2021
Initiated May 26, 2021
Classification Class II
Status Terminated
Quantity 460 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential that the pressure tubing may detach from the blood sampling system
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1959-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9335]
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 that the pressure tubing may detach from the blood sampling system
Code information Lot #s: 63505216 and 63590087
Distribution pattern US: AZ CA CO CT DC DE FL GA ID IL IN KY LA MA MD ME MI MN MO MS MT NC ND NE NJ PR SD TX UT VA WA WI WV OUS: Canada, United Kingdom, Italy
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[35256]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 8
Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 07460691954489
Z-1960-2021
Recall number Z-1960-2021
Initiated May 26, 2021
Classification Class II
Status Terminated
Quantity 700 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential that the pressure tubing may detach from the blood sampling system
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1960-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15566]
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 that the pressure tubing may detach from the blood sampling system
Code information Lot #s: 63470654, 63505217 and 63592430
Distribution pattern US: AZ CA CO CT DC DE FL GA ID IL IN KY LA MA MD ME MI MN MO MS MT NC ND NE NJ PR SD TX UT VA WA WI WV OUS: Canada, United Kingdom, Italy
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[31858]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 8
Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691930174 ***Not Marketed within the US
Z-1961-2021
Recall number Z-1961-2021
Initiated May 26, 2021
Classification Class II
Status Terminated
Quantity 290 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential that the pressure tubing may detach from the blood sampling system
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1961-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33476]
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 that the pressure tubing may detach from the blood sampling system
Code information Lot # 63479666- Not Marketed within the US
Distribution pattern US: AZ CA CO CT DC DE FL GA ID IL IN KY LA MA MD ME MI MN MO MS MT NC ND NE NJ PR SD TX UT VA WA WI WV OUS: Canada, United Kingdom, Italy
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[32697]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 8
Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520
Z-1962-2021
Recall number Z-1962-2021
Initiated May 26, 2021
Classification Class II
Status Terminated
Quantity 2,000 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential that the pressure tubing may detach from the blood sampling system
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1962-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33478]
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 that the pressure tubing may detach from the blood sampling system
Code information Lot # 63456332
Distribution pattern US: AZ CA CO CT DC DE FL GA ID IL IN KY LA MA MD ME MI MN MO MS MT NC ND NE NJ PR SD TX UT VA WA WI WV OUS: Canada, United Kingdom, Italy
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[32996]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 8
Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782
Z-1963-2021
Recall number Z-1963-2021
Initiated May 26, 2021
Classification Class II
Status Terminated
Quantity 1,679 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential that the pressure tubing may detach from the blood sampling system
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1963-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[28232]
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 that the pressure tubing may detach from the blood sampling system
Code information Lot # 63445142 and 63630816
Distribution pattern US: AZ CA CO CT DC DE FL GA ID IL IN KY LA MA MD ME MI MN MO MS MT NC ND NE NJ PR SD TX UT VA WA WI WV OUS: Canada, United Kingdom, Italy
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[34174]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 8
Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only, CE, UDI: (01)57460691950370
Z-1964-2021
Recall number Z-1964-2021
Initiated May 26, 2021
Classification Class II
Status Terminated
Quantity 990 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential that the pressure tubing may detach from the blood sampling system
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1964-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[40094]
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 that the pressure tubing may detach from the blood sampling system
Code information Lot # 63438489
Distribution pattern US: AZ CA CO CT DC DE FL GA ID IL IN KY LA MA MD ME MI MN MO MS MT NC ND NE NJ PR SD TX UT VA WA WI WV OUS: Canada, United Kingdom, Italy
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[35251]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 8
Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547
Z-1965-2021
Recall number Z-1965-2021
Initiated May 26, 2021
Classification Class II
Status Terminated
Quantity 50 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential that the pressure tubing may detach from the blood sampling system
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1965-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51988]
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 that the pressure tubing may detach from the blood sampling system
Code information Lot # 63598812
Distribution pattern US: AZ CA CO CT DC DE FL GA ID IL IN KY LA MA MD ME MI MN MO MS MT NC ND NE NJ PR SD TX UT VA WA WI WV OUS: Canada, United Kingdom, Italy
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[35170]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 8
Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746
Z-1966-2021
Recall number Z-1966-2021
Initiated May 26, 2021
Classification Class II
Status Terminated
Quantity 90 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential that the pressure tubing may detach from the blood sampling system
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1966-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58299]
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 that the pressure tubing may detach from the blood sampling system
Code information Lot # 63545959
Distribution pattern US: AZ CA CO CT DC DE FL GA ID IL IN KY LA MA MD ME MI MN MO MS MT NC ND NE NJ PR SD TX UT VA WA WI WV OUS: Canada, United Kingdom, Italy
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[32852]
FDA event record
· Exact recall-number query on openFDA
