SurgiMend 3 — Class II medical device recall Z-2074-2023
Ongoing recall by TEI Biosciences, Inc., reported 2023-07-12, distributed nationwide. Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxi
| Recall number | Z-2074-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | TEI Biosciences, Inc., Boston, MA, United States |
| Recall initiated | 2023-05-23 |
| Classified | 2023-07-03 |
| Reported by FDA | 2023-07-12 |
| Distributed | Nationwide (US) |
| Quantity | 13,390 units |
| Reason classes | sterility, specification failure |
| UPC / GTIN / UDI-DI | 10381780113072, 10381780113089, 10381780113096, 10381780113102, 10381780113119, 10381780113126, 10381780113133, 10381780113140, 10381780113157, 10381780113164, 10381780113171, 10381780113188, 10381780113195 |
| Model numbers | 606-300-002, 606-300-004, 606-300-006, 606-300-008, 606-300-009, 606-300-016, 606-300-017, 606-300-019, 606-300-020, 606-300-021, 606-300-022, 606-304-001, 606-304-002 |
Product
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.
Reason for recall
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2074-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.