Various products which were contract sterilized — Class II medical device recall Z-0259-2020
Ongoing recall by Anewmed Corporation, reported 2019-11-06, distributed nationwide. The contract sterilizer did not have adequate packaging data to support the 2-year shelf life.
| Recall number | Z-0259-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Anewmed Corporation, Tucker, GA, United States |
| Recall initiated | 2019-05-23 |
| Classified | 2019-10-31 |
| Reported by FDA | 2019-11-06 |
| Distributed | Nationwide (US) |
| Quantity | 1,749 devices |
| Lot numbers | 100, 1000-90, 10031, 101, 1011895H, 102, 103, 104, 1046764, 1049334, 105, 105-5092-150, 106, 107, 108, 109, 110, 111, 112, 112750, 113, 113230, 114, 115, 115311, 115321, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129 and 199 more |
Product
Various products which were contract sterilized.
Reason for recall
The contract sterilizer did not have adequate packaging data to support the 2-year shelf life.
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-0259-2020. 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.