Class II — Southmedic, Inc.
| Recalling firm | SOUTHMEDIC, INC. |
|---|---|
| Registered facility | SOUTHMEDIC, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO |
| Quantity | 450 units |
| Distribution | US Nationwide distribution in the state of IL. |
| Initiated | 2022-10-27 |
| Classified | 2022-11-23 |
| Recall number | Z-0279-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Southmedic, Inc. (Z-0279-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91129/
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