FDA Device recall Z-0279-2023
Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
- FDA Device
- Class II
- ongoing
- Published 2022-11-30
On 2022-11-30 the FDA classified a Class II recall of Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO by Southmedic, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0279-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-10-27 |
| Published | 2022-11-30 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Southmedic |
| Distribution | US |
Product
Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
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.
Identifiers
| code_info | GTIN 620974002628, Lot number: W92761 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0279-2023%22
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