Facility

SOUTHMEDIC, INC.

4 recall(s) on record — most severe on record: Class II.

Key facts

4recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3001717360
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	50 ALLIANCE BLVD., BARRIE Ontario, CA L4M 5K3
Registration status	Active · expires 2026
Parent company	SOUTHMEDIC, INC. (owner-operator 8022032)

Activity by year

Recalls (4)

Devices registered here (1)

Dna Specimen Collection, Saliva
Product code OYJ (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1675

Recalls & enforcement

Class IIOngoing2022-10-27
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.
Class IIOngoing2021-05-25
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.
Class IITerminated2017-11-06
Scalpels lot contains non-sterile products labeled as sterile.
Class IITerminated2017-10-17
Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.

All facilities operated by SOUTHMEDIC, INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “SOUTHMEDIC, INC. (FEI 3001717360) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3001717360-southmedic-inc/

Not open yet

Alerts for SOUTHMEDIC, INC.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.