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 14801–14820 of 38,428 recalls

June 18, 2020· Synthes, Inc.

Recalled Item: MatrixNEURO Screws - Product Usage: The intended use for this

The Issue: One lot of MatrixNEURO 5mm screws was packaged

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

Class II — Potential Health HazardTerminated
June 17, 2020· Beckman Coulter Biomedical GmbH

Recalled Item: DxA 5000

The Issue: The DxA 5000 instructions for use may be

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

Class II — Potential Health HazardTerminated
June 17, 2020· Resource Optimization & Innovation LLC

Recalled Item: regard Migrating Indicator

The Issue: The firm received reports from customer that the

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

Class II — Potential Health HazardTerminated
June 17, 2020· Wellspect HealthCare (Division of DENTSPLY IH AB)

Recalled Item: LoFric Origo

The Issue: Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo"

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

Class II — Potential Health HazardTerminated
June 17, 2020· Wellspect HealthCare (Division of DENTSPLY IH AB)

Recalled Item: LoFric Origo

The Issue: Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo"

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

Class II — Potential Health HazardTerminated
June 17, 2020· Wellspect HealthCare (Division of DENTSPLY IH AB)

Recalled Item: LoFric Origo

The Issue: Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo"

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

Class II — Potential Health HazardTerminated
June 17, 2020· FHC, Inc.

Recalled Item: FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product

The Issue: An electrical sub-circuit was not properly connected. Its

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

Class II — Potential Health HazardTerminated
June 16, 2020· Synthes Produktions GmbH

Recalled Item: MatrixMIDFACE Screws - Product Usage: The intended use for this

The Issue: One lot of MatrixMIDFACE Emergency Screw 1.8mm, self-tapp,

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

Class II — Potential Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: BodyGuard Microset

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: BodyGuard Microset With Female Luer

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: BodyGuard Microset

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: BodyGuard BodySet

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: BodyGuard Microset

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: CMExpress Microbore Sets

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: BodyGuard set with Female Luer

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: BodyGuard Microset

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: BodyGuard Microset with Filter

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: BodyGuard Microset with Filter and Manual Priming Valve

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: Standard BodySet with Needleless Connectors

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated