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 5581–5600 of 38,428 recalls

March 22, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline medical procedure kits labeled as follows: a) ENDO KIT

The Issue: A slight dimensional variation which has the potential

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

Class II — Potential Health HazardOngoing
March 22, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline medical procedure kits labeled as follows: a) BASIC NEURO

The Issue: A slight dimensional variation which has the potential

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

Class II — Potential Health HazardOngoing
March 22, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline medical procedure kits labeled as follows: a) ANESTHESIA CIRCUIT

The Issue: A slight dimensional variation which has the potential

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

Class II — Potential Health HazardOngoing
March 22, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline medical procedure kits labeled as follows: a) GYN CDS

The Issue: A slight dimensional variation which has the potential

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

Class II — Potential Health HazardOngoing
March 22, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline medical procedure kits labeled as follows: a) ENDO KIT

The Issue: A slight dimensional variation which has the potential

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

Class II — Potential Health HazardOngoing
March 22, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline medical procedure kits labeled as follows: a) C-SECTION CDS

The Issue: A slight dimensional variation which has the potential

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

Class II — Potential Health HazardOngoing
March 22, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline medical procedure kits labeled as follows: a) MAJOR BREAST

The Issue: A slight dimensional variation which has the potential

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

Class II — Potential Health HazardOngoing
March 22, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline medical procedure kits labeled as follows: a) ARTHROSCOPY

The Issue: A slight dimensional variation which has the potential

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

Class II — Potential Health HazardOngoing
March 22, 2024· EBI, LLC

Recalled Item: 48" Lead Wires

The Issue: Damage to the lead wire sheath (black cable)

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

Class II — Potential Health HazardOngoing
March 22, 2024· EBI, LLC

Recalled Item: Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the

The Issue: Damage to the lead wire sheath (black cable)

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

Class II — Potential Health HazardOngoing
March 22, 2024· Parker Laboratories, Inc.

Recalled Item: Redux Electrolyte Creme

The Issue: Product demonstrates low viscosity

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

Class II — Potential Health HazardOngoing
March 22, 2024· Philips North America Llc

Recalled Item: Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS):

The Issue: failure of Uninterruptable Power Supply (UPS) devices

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

Class II — Potential Health HazardOngoing
March 22, 2024· EBI, LLC

Recalled Item: 20" Lead Wires

The Issue: Damage to the lead wire sheath (black cable)

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

Class II — Potential Health HazardOngoing
March 22, 2024· EBI, LLC

Recalled Item: Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the...

The Issue: Damage to the lead wire sheath (black cable)

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

Class II — Potential Health HazardOngoing
March 21, 2024· SonarMed Inc

Recalled Item: AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed

The Issue: The failure to detect the partial obstruction in

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

Class I — Serious Health HazardOngoing
March 21, 2024· Boston Scientific Corporation

Recalled Item: Expo 5F Selective Angiographic Catheters

The Issue: An increase in complaints related to an inability

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

Class I — Serious Health HazardOngoing
March 21, 2024· SonarMed Inc

Recalled Item: AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed

The Issue: The failure to detect the partial obstruction in

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

Class I — Serious Health HazardOngoing
March 21, 2024· Boston Scientific Corporation

Recalled Item: Expo 5F Selective Angiographic Catheters

The Issue: An increase in complaints related to an inability

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

Class I — Serious Health HazardOngoing
March 21, 2024· Boston Scientific Corporation

Recalled Item: Expo 5F Selective Angiographic Catheters

The Issue: An increase in complaints related to an inability

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

Class I — Serious Health HazardOngoing
March 21, 2024· Boston Scientific Corporation

Recalled Item: Expo 5F Selective Angiographic Catheters

The Issue: An increase in complaints related to an inability

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

Class I — Serious Health HazardOngoing