Browse Device Recalls
5 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 5 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 11, 2024 | Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Numb... | A customer found product with incomplete seals of P/N 20400161S, lot #185198 which can lead to no... | Class II | Canadian Hospital Specialties Ltd. |
| Aug 19, 2022 | MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001 | Some of the labels of the kits for product code 10-4001 in the specified lots have an illegible b... | Class III | Canadian Hospital Specialties |
| Jul 16, 2019 | MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.... | The firm received a complaint that the connector detached from the feeding tube. | Class II | Canadian Hospital Specialties |
| Dec 1, 2018 | MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque St... | The product may be packaged with a 5FR X 24 length Feeding tube instead of a 6.5 FR X 24 Feedin... | Class II | Canadian Hospital Specialties |
| Jun 11, 2018 | MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pedia... | The product may be packaged with the incorrect length of feeding tube as labeled. | Class II | Canadian Hospital Specialties |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.