PriMatrix Ag — Class II medical device recall Z-2080-2023
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-2080-2023 |
|---|---|
| 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 | 1,689 units |
| Reason classes | sterility, specification failure |
| UPC / GTIN / UDI-DI | 10381780113492, 10381780113508, 10381780113515, 10381780113522, 10381780113539, 10381780113546, 10381780113553 |
| Model numbers | 607-101-112, 607-101-125, 607-101-225, 607-101-440, 607-101-660, 607-101-812, 607-101-880 |
Product
PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
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-2080-2023. 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.