Z-0279-2023Class II

Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO

Name: Z-0279-2023 Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
Creator: Southmedic, Inc.
Published: 2022-10-27
License: https://open.fda.gov/license/

Southmedic Inc. / initiated 2022-10-27 / Open, Classified / root cause: labeling and UDI

FDA source

Southmedic, Inc. began a recall of Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO on 2022-10-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0279-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-10-27
Posted: 2022-11-23
Recalling firm: Southmedic Inc.
Product: Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
Product code: GES Blade, Scalpel
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 450 units
Distribution: US Nationwide distribution in the state of IL.
Product codes and lots: GTIN 620974002628, Lot number: W92761

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0279-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0279-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-30	2022-11-23

Product code GES

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)