Southmedic, Inc. FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EOClass IIOct 27, 2022Upon review of its batch record, Southmedic identified that	Upon review of its batch record, Southmedic identified that lot # W92761 was not sent out for sterilization, a	Class IIDevices	Oct 27, 2022
OxyMask O2 Adult REF OM-1125-14Class IIMay 25, 2021Potential for oxygen tubing to disconnect from mask or loose	Potential for oxygen tubing to disconnect from mask or loosen. Disconnected tubing results in a loss of dev	Class IIDevices	May 25, 2021