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 1481–1500 of 38,428 recalls

August 13, 2025· Philips North America Llc

Recalled Item: Philips CT systems labeled as the following: 1. CT 6000

The Issue: The patient support table (couch) may descend unexpectedly

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

Class II — Potential Health HazardOngoing
August 13, 2025· Philips North America Llc

Recalled Item: Philips CT systems labeled as the following: 1. Brilliance 16 Power

The Issue: The patient support table (couch) may descend unexpectedly

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

Class II — Potential Health HazardOngoing
August 13, 2025· Philips North America Llc

Recalled Item: Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel

The Issue: The patient support table (couch) may descend unexpectedly

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

Class II — Potential Health HazardOngoing
August 13, 2025· Philips North America Llc

Recalled Item: Philips CT systems labeled as the following: 1. Ingenuity CT 728326

The Issue: The patient support table (couch) may descend unexpectedly

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

Class II — Potential Health HazardOngoing
August 13, 2025· Philips North America Llc

Recalled Item: Philips CT systems labeled as the following: 1. Ingenuity Core128

The Issue: The patient support table (couch) may descend unexpectedly

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

Class II — Potential Health HazardOngoing
August 13, 2025· Philips North America Llc

Recalled Item: Philips CT systems labeled as the following: 1. Brilliance iCT SP

The Issue: The patient support table (couch) may descend unexpectedly

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

Class II — Potential Health HazardOngoing
August 13, 2025· Beckman Coulter Inc.

Recalled Item: UniCel DxH 800 COULTER Cellular Analysis System

The Issue: Hematology analyzers configured with HGB photometers may result

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

Class II — Potential Health HazardOngoing
August 13, 2025· Beckman Coulter Inc.

Recalled Item: UniCel DxH 900 COULTER Cellular Analysis System

The Issue: Hematology analyzers configured with HGB photometers may result

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

Class II — Potential Health HazardOngoing
August 13, 2025· Beckman Coulter Inc.

Recalled Item: UniCel DxH 690T COULTER Cellular Analysis System

The Issue: Hematology analyzers configured with HGB photometers may result

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

Class II — Potential Health HazardOngoing
August 13, 2025· Beckman Coulter Inc.

Recalled Item: UniCel DxH 600 COULTER Cellular Analysis System

The Issue: Hematology analyzers configured with HGB photometers may result

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

Class II — Potential Health HazardOngoing
August 12, 2025· Applied Medical Technology Inc

Recalled Item: NutraGlide Nasal Feeding Tube with Stylet and ENFit

The Issue: The nasal feeding tubes, NutraGlide, subject to this

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

Class II — Potential Health HazardOngoing
August 12, 2025· Applied Medical Technology Inc

Recalled Item: NutraGlide Nasal Feeding Tube with Stylet and ENFit

The Issue: The nasal feeding tubes, NutraGlide, subject to this

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

Class II — Potential Health HazardOngoing
August 12, 2025· Applied Medical Technology Inc

Recalled Item: NutraGlide Nasal Feeding Tube with Stylet and ENFit

The Issue: The nasal feeding tubes, NutraGlide, subject to this

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

Class II — Potential Health HazardOngoing
August 12, 2025· Applied Medical Technology Inc

Recalled Item: NutraGlide Nasal Feeding Tube with Stylet and ENFit

The Issue: The nasal feeding tubes, NutraGlide, subject to this

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

Class II — Potential Health HazardOngoing
August 12, 2025· Max Mobility LLC

Recalled Item: Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial use

The Issue: Due to a faulty electrical connection between the

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

Class I — Serious Health HazardOngoing
August 12, 2025· Max Mobility LLC

Recalled Item: Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial use

The Issue: Due to a faulty electrical connection between the

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

Class I — Serious Health HazardOngoing
August 12, 2025· Max Mobility LLC

Recalled Item: Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial use

The Issue: Due to a faulty electrical connection between the

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

Class I — Serious Health HazardOngoing
August 12, 2025· Siemens Medical Solutions USA, Inc

Recalled Item: Artis Pheno. Image-Intensified Flouroscopic X-Ray System.

The Issue: Limited system movements after startup

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

Class II — Potential Health HazardOngoing
August 11, 2025· Agilent Technologies Denmark ApS

Recalled Item: FLEX Monoclonal Mouse Anti-Human CD20cy

The Issue: Their is the potential for weak staining which

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

Class II — Potential Health HazardOngoing
August 11, 2025· Agilent Technologies Denmark ApS

Recalled Item: FLEX Monoclonal Mouse Anti-Human CD20cy

The Issue: Their is the potential for weak staining which

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

Class II — Potential Health HazardOngoing