Medical Device Recalls

This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.

Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.

38,428 total recalls
0 this month

Showing 8361–8380 of 38,428 recalls

April 22, 2023· Merit Medical Systems, Inc.

Recalled Item: Aspira Drainage Catheter Insertion Tray 15.5F

The Issue: There is a potential that valve assemblies will

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 22, 2023· Merit Medical Systems, Inc.

Recalled Item: Aspira Drainage Catheter Insertion Tray 15.5F

The Issue: There is a potential that valve assemblies will

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 22, 2023· Merit Medical Systems, Inc.

Recalled Item: Aspira Pleural Drainage Catheter Insertion Tray 15.5F

The Issue: There is a potential that valve assemblies will

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 22, 2023· Merit Medical Systems, Inc.

Recalled Item: Aspira Drainage Catheter Insertion Tray 15.5F

The Issue: There is a potential that valve assemblies will

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 22, 2023· Merit Medical Systems, Inc.

Recalled Item: Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F

The Issue: There is a potential that valve assemblies will

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 22, 2023· Merit Medical Systems, Inc.

Recalled Item: Aspira Pleural Drainage Catheter Insertion Tray 15.5F

The Issue: There is a potential that valve assemblies will

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 22, 2023· Merit Medical Systems, Inc.

Recalled Item: Aspira Pleural Drainage Catheter Insertion Tray 15.5F

The Issue: There is a potential that valve assemblies will

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 22, 2023· Merit Medical Systems, Inc.

Recalled Item: Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F

The Issue: There is a potential that valve assemblies will

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 22, 2023· Merit Medical Systems, Inc.

Recalled Item: Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F

The Issue: There is a potential that valve assemblies will

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 22, 2023· Merit Medical Systems, Inc.

Recalled Item: Aspira Drainage Catheter Insertion Tray 15.5F

The Issue: There is a potential that valve assemblies will

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 22, 2023· Merit Medical Systems, Inc.

Recalled Item: Aspira Valve Repair Kit

The Issue: There is a potential that valve assemblies will

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 22, 2023· Merit Medical Systems, Inc.

Recalled Item: Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F

The Issue: There is a potential that valve assemblies will

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 21, 2023· Masimo Corporation

Recalled Item: Masimo LNCS TC-I SpO2

The Issue: TC-I tip clip sensor may produce readings outside

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 21, 2023· Masimo Corporation

Recalled Item: Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor

The Issue: TC-I tip clip sensor may produce readings outside

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 21, 2023· Masimo Corporation

Recalled Item: Masimo LNCS TC-I SpO2

The Issue: TC-I tip clip sensor may produce readings outside

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 21, 2023· Masimo Corporation

Recalled Item: Masimo LNOP TC-I SpO2

The Issue: TC-I tip clip sensor may produce readings outside

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 21, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Procedure packs: (1) Medline Sterile Arthroscopy Pack

The Issue: The kits were damaged by water

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 20, 2023· C.R. Bard Inc

Recalled Item: HydroSil Go Intermittent Urinary Catheters

The Issue: Some catheters had a manufacturing defect where the

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 20, 2023· C.R. Bard Inc

Recalled Item: Magic3 Go Intermittent Urinary Catheters

The Issue: Some catheters had a manufacturing defect where the

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 20, 2023· C.R. Bard Inc

Recalled Item: Magic3 Go Intermittent Urinary Catheters

The Issue: Some catheters had a manufacturing defect where the

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing