Barrie, N/A, Canada
Southmedic, Inc. recalls
4 recalls recorded since 2018, most recently on 27 October 2022. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)2
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 27 October 2022
- 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.
- Distribution
- US Nationwide distribution in the state of IL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0279-2023
- Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
Ongoing Class II Medical devices
- Recall started
- 25 May 2021
- Reason
- Potential for oxygen tubing to disconnect from mask or loosen. Disconnected tubing results in a loss of device function and use of the device could result in inappropriate or a lack of oxygen delivery to the patient.
- Distribution
- U.S.: IL O.U.S.: N/A
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2141-2021
- OxyMask O2 Adult REF OM-1125-14
Terminated Class II Medical devices
- Recall started
- 6 November 2017
- Terminated
- 2 April 2020
- Reason
- Scalpels lot contains non-sterile products labeled as sterile.
- Distribution
- US Distribution to the states of : IA, IL, NE, NY and TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1892-2018
- Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue.
Terminated Class II Medical devices
- Recall started
- 17 October 2017
- Terminated
- 29 March 2024
- Reason
- Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.
- Distribution
- US Distribution to the state of California, and Internationally to Canada and Sweden
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1288-2018
- Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breathing by providing a
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.