SurgiMend PRS — Class II medical device recall Z-2070-2023
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-2070-2023 |
|---|---|
| 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 | 22,163 units |
| Reason classes | sterility, specification failure |
| UPC / GTIN / UDI-DI | 10381780112822, 10381780112839, 10381780112846, 10381780112853, 10381780112860, 10381780112877, 10381780112884, 10381780112891, 10381780112907, 10381780112914, 10381780112921, 10381780112938, 10381780112945, 10381780357322 |
| Model numbers | 606-004-100, 606-004-101, 606-004-102, 606-004-103, 606-004-104, 606-004-105, 606-004-106, 606-004-107, 606-004-108, 606-004-109, 606-004-110, 606-005-001, 606-005-002, 606-007-001 |
Product
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
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-2070-2023. 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.