Recall events
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Event 92481
Event summary
Timeline bucket May 23, 2023
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording TEI Biosciences, Inc.
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
17 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 17
SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10x15 cm, 1.0 10x20 cm, 1.0 16x20 cm, 1.0 13x25 cm, 1.0 4x16 cm, 1.0 3x3 cm, 1.0 4x7 cm, 1.0 4x12 cm, 1.0 6x16 cm, 1.0 25x40 cm, 1.0 20 x 30 cm, 1.0 8x16 cm, 1.0 4x7 cm Thin, 1.0 5x6 cm Thin, 1.0 3x3 cm Thin, 1.0 0.3x25 cm, 1.0 0.6x25 cm, 1.0 1x25 cm.
Z-2069-2023
Recall number Z-2069-2023
Initiated May 23, 2023
Classification Class II
Status Ongoing
Quantity 14,535 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out of specification
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-2069-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4986]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Code information Item No. (UDI-DI): 606-001-002 (10381780112617), 606-001-004 (10381780112624), 606-001-005 (10381780112631), 606-001-006 (10381780112648), 606-001-007 (10381780112655), 606-001-008 (10381780112662), 606-001-009 (10381780112679), 606-001-010 (10381780112686), 606-001-012 (10381780112693), 606-001-013 (10381780112709), 606-001-014 (10381780112716), 606-001-015 (10381780112723), 606-001-016 (10381780112730), 606-001-017 (10381780112747), 606-001-018 (10381780112754), 606-002-002 (10381780112761), 606-002-003 (10381780112778), 606-002-005 (10381780112785), 606-003-001 (10381780112792), 606-003-002 (10381780112808), 606-003-003 (10381780112815).
Distribution pattern Domestic: 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[37889]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 17
SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 10x20 cm Fenestrated, 8x16 cm Semi-Oval, 15x15 cm Semi-Oval, 8x20 cm Fenestrated, 10x15 cm Slant Fenestrated, 7x17 cm Semi-Oval, 8x16 cm Thin Semi-Oval, 10x20 cm Thin Semi-Oval, 6x16 cm Semi-Oval, Thin Oval 8x12 cm, Thin Oval 10x15 cm, Meshed 20cm x 10cm
Z-2070-2023
Recall number Z-2070-2023
Initiated May 23, 2023
Classification Class II
Status Ongoing
Quantity 22,163 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out of specification
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-2070-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[40516]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Code information Item No. (UDI-DI): 606-004-100 (10381780112822), 606-004-101 (10381780112839), 606-004-102 (10381780112846), 606-004-103 (10381780112853), 606-004-104 (10381780112860), 606-004-105 (10381780112877), 606-004-106 (10381780112884), 606-004-107 (10381780112891), 606-004-108 (10381780112907), 606-004-109 (10381780112914), 606-004-110 (10381780112921), 606-005-001 (10381780112938), 606-005-002 (10381780112945), 606-007-001 (10381780357322).
Distribution pattern Domestic: 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[37398]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 17
SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.
Z-2071-2023
Recall number Z-2071-2023
Initiated May 23, 2023
Classification Class II
Status Ongoing
Quantity 52 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out of specification
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-2071-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21934]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Code information Item No. (UDI-DI): 606-005-003 (10381780112952) and 606-005-004 (10381780112969).
Distribution pattern Domestic: 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[37997]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 17
SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25cm, 10x15cm Semi-Oval,
Z-2072-2023
Recall number Z-2072-2023
Initiated May 23, 2023
Classification Class II
Status Ongoing
Quantity 2,392 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out of specification
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-2072-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4980]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Code information Item No. (UDI-DI): 606-200-002 (10381780112976), 606-200-004 (10381780112983), 606-200-006 (10381780112990), 606-200-008 (10381780113003), 606-200-009 (10381780113010), 606-200-016 (10381780113027), 606-200-017 (10381780113034), 606-200-019 (10381780113041), 606-200-020 (10381780113058), and 606-204-100 (10381780113065).
Distribution pattern Domestic: 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[38008]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 17
SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x25 cm, 20x30 cm, and 25x40 cm.
Z-2073-2023
Recall number Z-2073-2023
Initiated May 23, 2023
Classification Class II
Status Ongoing
Quantity 3,992 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out of specification
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-2073-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21940]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Code information Item No. (UDI-DI): 606-206-001 (10381780357339), 606-206-002 (10381780357360), 606-206-003 (10381780357346), 606-206-004 (10381780357353), 606-206-005 (10381780357377), 606-206-006 (10381780357384), and 606-206-007 (10381780357391).
Distribution pattern Domestic: 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[37759]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 17
SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25 cm, 1x5 cm, 10x25 cm 4x7cm Fenestrated, and 10x25 cm Fenestrated.
Z-2074-2023
Recall number Z-2074-2023
Initiated May 23, 2023
Classification Class II
Status Ongoing
Quantity 13,390 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out of specification
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-2074-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51916]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Code information Item No. (UDI-DI): 606-300-002 (10381780113072), 606-300-004 (10381780113089) 606-300-006 (10381780113096), 606-300-008 (10381780113102), 606-300-009 (10381780113119), 606-300-016 (10381780113126), 606-300-017 (10381780113133), 606-300-019 (10381780113140), 606-300-020 (10381780113157), 606-300-021 (10381780113164), 606-300-022 (10381780113171), 606-304-001 (10381780113188), and 606-304-002 (10381780113195).
Distribution pattern Domestic: 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[37753]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 17
SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40 cm, 20x30 cm, 10x25 cm, 20x0.5 cm, and 10x25 cm Fenestrated.
Z-2075-2023
Recall number Z-2075-2023
Initiated May 23, 2023
Classification Class II
Status Ongoing
Quantity 5,664 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out of specification
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-2075-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[57379]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Code information Item No. (UDI-DI): 606-400-002 (10381780113201), 606-400-004 (10381780113218), 606-400-006 (10381780113225), 606-400-009 (10381780113232), 606-400-016 (10381780113249), 606-400-017 (10381780113256), 606-400-018 (10381780113263), 606-403-001 (10381780113270), and 606-404-001 (10381780113287).
Distribution pattern Domestic: 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[37975]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 17
SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm
Z-2076-2023
Recall number Z-2076-2023
Initiated May 23, 2023
Classification Class II
Status Ongoing
Quantity 9,215 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out of specification
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-2076-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46290]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Code information Item No. 606-907-001. No UDI-DI (Distributed in Canada and EU).
Distribution pattern Domestic: 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[37969]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 17
PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm.
Z-2077-2023
Recall number Z-2077-2023
Initiated May 23, 2023
Classification Class II
Status Ongoing
Quantity 4,159 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out of specification
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-2077-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51915]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Code information Item No. (UDI-DI): 607-001-009 (10381780113294), 607-001-112 (10381780113300), 607-001-125 (10381780113317), 607-001-225 (10381780113324), 607-001-440 (10381780113331), 607-001-660 (10381780113348), 607-001-812 (10381780113355), 607-001-880 (10381780113362).
Distribution pattern Domestic: 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[37886]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2078-2023
Initiated May 23, 2023
Classification Class II
Status Ongoing
Quantity 30,528 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out of specification
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-2078-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21937]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Code information Item No. (UDI-DI): 607-004-440 (10381780113379), 607-004-660 (10381780113386), 607-004-880 (10381780113393), 607-005-014 (10381780357414), 607-005-018 (10381780357421), 607-005-125 (10381780113409), 607-005-220 (10381780357407).
Distribution pattern Domestic: 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[37756]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2079-2023
Initiated May 23, 2023
Classification Class II
Status Ongoing
Quantity 33,277 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out of specification
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-2079-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16739]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Code information Item No. (UDI-DI): 607-005-225 (10381780113423), 607-005-330 (10381780113430), 607-005-440 (10381780113447), 607-005-550 (10381780113454), 607-005-660 (10381780113461), 607-005-812 (10381780113478), 607-005-880 (10381780113485).
Distribution pattern Domestic: 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[37978]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2080-2023
Initiated May 23, 2023
Classification Class II
Status Ongoing
Quantity 1,689 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out of specification
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-2080-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4984]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Code information Item No. (UDI-DI): 607-101-112 (10381780113492), 607-101-125 (10381780113508), 607-101-225 (10381780113515), 607-101-440 (10381780113522), 607-101-660 (10381780113539), 607-101-812 (10381780113546), 607-101-880 (10381780113553).
Distribution pattern Domestic: 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[38002]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2081-2023
Initiated May 23, 2023
Classification Class II
Status Ongoing
Quantity 7,264 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out of specification
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-2081-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51911]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Code information Item No. (UDI-DI): 607-104-125(10381780113775) , 607-104-225 (10381780113782), 607-104-440 (10381780113560), 607-104-660 (10381780113577), 607-104-812 (10381780113768), 607-104-880 (10381780113584).
Distribution pattern Domestic: 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[37391]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2082-2023
Initiated May 23, 2023
Classification Class II
Status Ongoing
Quantity 10,159 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out of specification
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-2082-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51917]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
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Reason for recall Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Code information Item No. (UDI-DI): 607-105-112 (10381780177685), 607-105-125 (10381780113591), 607-105-225 (10381780113607), 607-105-440 (10381780113614), 607-105-660 (10381780177715), 607-105-812 (10381780177739), 607-105-880 (10381780177722).
Distribution pattern Domestic: 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[4358]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2083-2023
Initiated May 23, 2023
Classification Class II
Status Ongoing
Quantity 199 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out of specification
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-2083-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21938]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Code information Item No. (UDI-DI): 611-001-001 (10381780357292), 611-001-002 (10381780357278), 611-001-003 (10381780357285).
Distribution pattern Domestic: 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[37392]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2084-2023
Initiated May 23, 2023
Classification Class II
Status Ongoing
Quantity 665 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out of specification
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-2084-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9675]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Code information Item No. (UDI-DI): 611-005-001 (10381780357308), 611-005-002 (10381780357315).
Distribution pattern Domestic: 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[37890]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2085-2023
Initiated May 23, 2023
Classification Class II
Status Ongoing
Quantity 4,832
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out of specification
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-2085-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9678]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Code information Item No. (UDI-DI): 6495-9-001 (10381780113621), 6495-9-004 (10381780113638), 6495-9-006 (10381780113645).
Distribution pattern Domestic: 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[37895]
FDA event record
· Exact recall-number query on openFDA
