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 6561–6580 of 38,428 recalls

November 30, 2023· Philips North America

Recalled Item: BrightView X

The Issue: While using Pre-Programmed Motion during an extrinsic quality

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

Class II — Potential Health HazardOngoing
November 30, 2023· Philips North America

Recalled Item: BrightView

The Issue: While using Pre-Programmed Motion during an extrinsic quality

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

Class II — Potential Health HazardOngoing
November 30, 2023· Philips North America

Recalled Item: BrightView XCT

The Issue: While using Pre-Programmed Motion during an extrinsic quality

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

Class II — Potential Health HazardOngoing
November 30, 2023· Boston Scientific Corporation

Recalled Item: Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM)...

The Issue: The software application on the Programmer/Recorder/Monitor (PRM) for

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

Class II — Potential Health HazardOngoing
November 30, 2023· Insulet Corporation

Recalled Item: Omnipod 5 App (on compatible Android smartphones)

The Issue: The bolus calculator is not recording the decimal

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

Class I — Serious Health HazardOngoing
November 30, 2023· Busse Hospital Disposables, Inc.

Recalled Item: Catalog No. 9251R1

The Issue: Firm is recalling all kits containing recalled lots

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

Class I — Serious Health HazardOngoing
November 30, 2023· Busse Hospital Disposables, Inc.

Recalled Item: Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE

The Issue: Firm is recalling all kits containing recalled lots

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

Class I — Serious Health HazardOngoing
November 30, 2023· Busse Hospital Disposables, Inc.

Recalled Item: Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE

The Issue: Firm is recalling all kits containing recalled lots

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

Class I — Serious Health HazardOngoing
November 29, 2023· Randox Laboratories Ltd.

Recalled Item: RX Series Copper (Cu) Assay Ref. Number CU2340

The Issue: Randox Laboratories have released an update to the

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

Class II — Potential Health HazardOngoing
November 29, 2023· American Contract Systems, Inc.

Recalled Item: Procedural convenience kits and trays

The Issue: During an internal investigation, ACS identified that several

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

Class II — Potential Health HazardOngoing
November 29, 2023· American Contract Systems, Inc.

Recalled Item: Custom procedural convenience kits and trays

The Issue: During an internal investigation, ACS identified that several

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

Class II — Potential Health HazardOngoing
November 29, 2023· American Contract Systems, Inc.

Recalled Item: Custom procedural convenience kits and trays

The Issue: During an internal investigation, ACS identified that several

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

Class II — Potential Health HazardOngoing
November 29, 2023· American Contract Systems, Inc.

Recalled Item: Custom procedural convenience kits and trays

The Issue: During an internal investigation, ACS identified that several

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

Class II — Potential Health HazardOngoing
November 29, 2023· American Contract Systems, Inc.

Recalled Item: Custom procedural convenience kits and trays

The Issue: During an internal investigation, ACS identified that several

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

Class II — Potential Health HazardOngoing
November 29, 2023· American Contract Systems, Inc.

Recalled Item: Custom procedural convenience kits and trays

The Issue: During an internal investigation, ACS identified that several

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

Class II — Potential Health HazardOngoing
November 29, 2023· American Contract Systems, Inc.

Recalled Item: Custom procedural convenience kits and trays

The Issue: During an internal investigation, ACS identified that several

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

Class II — Potential Health HazardOngoing
November 29, 2023· American Contract Systems, Inc.

Recalled Item: Custom procedural convenience kits and trays

The Issue: During an internal investigation, ACS identified that several

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

Class II — Potential Health HazardOngoing
November 29, 2023· American Contract Systems, Inc.

Recalled Item: Custom procedural convenience kits and trays

The Issue: During an internal investigation, ACS identified that several

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

Class II — Potential Health HazardOngoing
November 29, 2023· American Contract Systems, Inc.

Recalled Item: Custom procedural convenience kits and trays

The Issue: During an internal investigation, ACS identified that several

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

Class II — Potential Health HazardOngoing
November 29, 2023· American Contract Systems, Inc.

Recalled Item: Custom procedural convenience kits and trays

The Issue: During an internal investigation, ACS identified that several

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

Class II — Potential Health HazardOngoing