SurgiMend 2 — Class II medical device recall Z-2072-2023
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-2072-2023 |
|---|---|
| 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 | 2,392 units |
| Reason classes | sterility, specification failure |
| UPC / GTIN / UDI-DI | 10381780112976, 10381780112983, 10381780112990, 10381780113003, 10381780113010, 10381780113027, 10381780113034, 10381780113041, 10381780113058, 10381780113065 |
| Model numbers | 606-200-002, 606-200-004, 606-200-006, 606-200-008, 606-200-009, 606-200-016, 606-200-017, 606-200-019, 606-200-020, 606-204-100 |
Product
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,
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-2072-2023. 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.