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 26781–26800 of 38,428 recalls

June 30, 2016· Zimmer Gmbh

Recalled Item: Avenir M¿ller Stem 4 Standard Avenir M¿ller Stem 6 Lateral

The Issue: Product mix-up. The Avenir M¿ller Stem 6 lateral

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

Class II — Potential Health HazardTerminated
June 29, 2016· Winco Mfg., LLC

Recalled Item: TransMotion Medical

The Issue: Non-conforming component caused arms of TMM4 Stretcher chair

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

Class II — Potential Health HazardTerminated
June 29, 2016· Winco Mfg., LLC

Recalled Item: TransMotion Medical

The Issue: Non-conforming component caused arms of TMM4 Stretcher chair

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

Class II — Potential Health HazardTerminated
June 29, 2016· Winco Mfg., LLC

Recalled Item: TransMotion Medical

The Issue: Non-conforming component caused arms of TMM4 Stretcher chair

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

Class II — Potential Health HazardTerminated
June 29, 2016· Carefusion 2200 Inc

Recalled Item: Broselow/Hinkle

The Issue: The Oral Airway pouch within the PINK/RED Oxygen

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

Class II — Potential Health HazardTerminated
June 29, 2016· Carefusion 2200 Inc

Recalled Item: Broselow/Hinkle

The Issue: The Oral Airway pouch within the PINK/RED Oxygen

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

Class II — Potential Health HazardTerminated
June 29, 2016· ARJOHUNTLEIGH POLSKA Sp. z.o.o.

Recalled Item: ArjoHuntleigh Sara Combilizer

The Issue: ArjoHuntleigh has concluded that a device tipping hazard

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

Class II — Potential Health HazardTerminated
June 29, 2016· TYRX Inc.

Recalled Item: TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization

The Issue: TRYX products are being recalled since the processes

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

Class II — Potential Health HazardTerminated
June 29, 2016· TYRX Inc.

Recalled Item: TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for...

The Issue: TRYX products are being recalled since the processes

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

Class II — Potential Health HazardTerminated
June 29, 2016· TYRX Inc.

Recalled Item: TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for...

The Issue: TRYX products are being recalled since the processes

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

Class II — Potential Health HazardTerminated
June 29, 2016· C.R. Bard, Inc.

Recalled Item: SureStep Tray

The Issue: Labeling problem

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

Class III — Low RiskTerminated
June 28, 2016· Medtronic Xomed, Inc.

Recalled Item: NIM EMG Endotracheal Tube

The Issue: Wire in tubing can become exposed, posing potential

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

Class II — Potential Health HazardTerminated
June 28, 2016· Trividia Health

Recalled Item: TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with

The Issue: Product gives incorrect low blood glucose levels

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

Class II — Potential Health HazardOngoing
June 28, 2016· Trividia Health

Recalled Item: TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with

The Issue: Product gives incorrect low blood glucose levels

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

Class II — Potential Health HazardOngoing
June 28, 2016· Trividia Health

Recalled Item: TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with

The Issue: Product gives incorrect low blood glucose levels

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

Class II — Potential Health HazardOngoing
June 28, 2016· Trividia Health

Recalled Item: TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with

The Issue: Product gives incorrect low blood glucose levels

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

Class II — Potential Health HazardOngoing
June 28, 2016· Synthes (USA) Products LLC

Recalled Item: Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm

The Issue: It was reported that the specified lots of

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

Class II — Potential Health HazardTerminated
June 28, 2016· CHG Hospital Beds Inc

Recalled Item: Spirit Plus Bed

The Issue: Stryker Medical is initiating a voluntary recall of

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

Class II — Potential Health HazardTerminated
June 28, 2016· B-K Medical A/S

Recalled Item: BK Medical ApS Ultrasound System Scanner bk2300 - Model #:

The Issue: In the system (bk3500) software generic volume measurement

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

Class II — Potential Health HazardTerminated
June 28, 2016· CHG Hospital Beds Inc

Recalled Item: Spirit Select Bed

The Issue: Stryker Medical is initiating a voluntary recall of

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

Class II — Potential Health HazardTerminated