Facility

CANADIAN HOSPITAL SPECIALTIES LTD

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

Key facts

5recalls · 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)	3003627840
Establishment type	Export Device to the United States But Perform No Other Operation on Device
Location	1213 International Blvd. Burlington Ontario, CA L7L 6W1
Registration status	Active · expires 2026
Parent company	Canadian Hospital Specialties Ltd. (owner-operator 10044194)

Activity by year

Recalls (5)

Devices registered here (4)

Laparoscope, General & Plastic Surgery
Product code GCJ (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.1500
Insufflator, Laparoscopic
Product code HIF (opens in a new tab) · Class II · Obstetrics/Gynecology · 21 CFR 884.1730
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Product code JCX (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4780
Collector, Urine, (And Accessories) For Indwelling Catheter
Product code KNX (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5250

Recalls & enforcement

Class IIOngoing2024-06-11
A customer found product with incomplete seals of P/N 20400161S, lot #185198 which can lead to non-sterile product and patient safety concerns. CHS has validated this complaint.
Class IIITerminated2022-08-19
Some of the labels of the kits for product code 10-4001 in the specified lots have an illegible barcode which prevents successful scanning of the package.
Class IITerminated2019-07-16
The firm received a complaint that the connector detached from the feeding tube.
Class IITerminated2018-12-01
The product may be packaged with a 5FR X 24 length Feeding tube instead of a 6.5 FR X 24 Feeding tube as labeled.
Class IITerminated2018-06-11
The product may be packaged with the incorrect length of feeding tube as labeled.

All facilities operated by Canadian Hospital Specialties Ltd.

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. “CANADIAN HOSPITAL SPECIALTIES LTD (FEI 3003627840) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003627840-canadian-hospital-specialties-ltd/

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