Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE — Class II medical device recall Z-0279-2023
Ongoing recall by Southmedic, Inc., reported 2022-11-30, distributed nationwide. Upon review of its batch record, Southmedic identified that lot # W92761 was not sent out for sterilization, a
| Recall number | Z-0279-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Southmedic, Inc., Barrie, N/A, Canada |
| Recall initiated | 2022-10-27 |
| Classified | 2022-11-23 |
| Reported by FDA | 2022-11-30 |
| Distributed | Nationwide (US) |
| Quantity | 450 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00620974002628 |
| Lot numbers | W92761 |
| Model numbers | 73-8020 |
Product
Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
Reason for recall
Upon review of its batch record, Southmedic identified that lot # W92761 was not sent out for sterilization, and was instead transferred directly to distribution where it was sold and distributed to customers as non-sterile product labelled as sterile.
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-0279-2023. 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.