FDA Medical Device Recalls (openFDA)
Southmedic, Inc.: Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
- Recall number
- Z-0279-2023
- Recalling firm
- Southmedic, Inc.
- Product
- Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
- Status
- Open, Classified
- Initiated
- 2022-10-27
- Posted
- 2022-11-23
- Terminated
- not on file
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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
- Quantity
- 450 units
- Distribution
- US Nationwide distribution in the state of IL.
- Lot, serial or model codes
- GTIN 620974002628, Lot number: W92761
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GES
- Firm FEI
- 3001717360
- Firm city
- Barrie
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28