STRADIS HEALTHCARE — Class II medical device recall Z-0495-2023
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-0495-2023 |
|---|---|
| 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 | 20 units |
| Reason classes | sterility |
| Lot numbers | 22230489097 |
| Model numbers | 41137TDS |
Product
STRADIS HEALTHCARE, DENTAL CUSTOM PACK, Item No.41137TDS,
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-0495-2023. 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.