Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL… recallZ-0279-2023 · Southmedic, Inc. · initiated Oct 27, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Southmedic, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
Southmedic sent and URGENT: MEDICAL DEVICE RECALL notice its consignees on 10/28/2022 by email. The notice explained the issue and requested the product be destroyed. The response forms indicate that the direct consignee notify its customers
Recall details
- Recall number
- Z-0279-2023
- Status
- Open, Classified
- Initiated by the company
- Oct 27, 2022
- Posted by the FDA
- Nov 23, 2022
- Recalling firm
- Southmedic, Inc.
- Quantity
- 450 units
- Product code
- GES
- Distribution
- US Nationwide distribution in the state of IL.
Product description
Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
Code information (models, lots, serial numbers)
GTIN 620974002628, Lot number: W92761
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SPSS Cartridges 73-8020Southmedic Incorporated · BLADE, SCALPEL1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page