HENRY SCHEIN — Class II medical device recall Z-0511-2023
Ongoing recall by Stradis Medical, LLC dba Stradis Healthcare, reported 2022-12-21, distributed nationwide. Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in th
| Recall number | Z-0511-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stradis Medical, LLC dba Stradis Healthcare, Peachtree Corners, GA, United States |
| Recall initiated | 2022-11-02 |
| Classified | 2022-12-14 |
| Reported by FDA | 2022-12-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 104 units |
| Reason classes | sterility |
| Lot numbers | 22242489582, 22256491864 |
| Model numbers | 570-2718 |
Product
HENRY SCHEIN, ENT PACK, Item No.570-2718
Reason for recall
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
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-0511-2023. 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.