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 12401–12420 of 38,428 recalls

May 12, 2021· Stryker Medical Division of Stryker Corporation

Recalled Item: InTouch 2131-intended to support a human patient in an acute care setting

The Issue: Medical devices intended for use in a healthcare

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

Class II — Potential Health HazardOngoing
May 12, 2021· Stryker Medical Division of Stryker Corporation

Recalled Item: S3 MedSurg Bed - intended to support and transport patients

The Issue: Medical devices intended for use in a healthcare

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

Class II — Potential Health HazardOngoing
May 12, 2021· Stryker Medical Division of Stryker Corporation

Recalled Item: Transport Stretcher 747 - a non-powered

The Issue: Medical devices intended for use in a healthcare

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

Class II — Potential Health HazardOngoing
May 12, 2021· Stryker Medical Division of Stryker Corporation

Recalled Item: CUB Pediatric Crib- intended to provide a pediatric patient support

The Issue: Medical devices intended for use in a healthcare

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

Class II — Potential Health HazardOngoing
May 12, 2021· Stryker Medical Division of Stryker Corporation

Recalled Item: Stretcher Chair-for use in all acute care hospitals and medical

The Issue: Medical devices intended for use in a healthcare

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

Class II — Potential Health HazardOngoing
May 12, 2021· Stryker Medical Division of Stryker Corporation

Recalled Item: ComfortGel - assists in the prevention and treatment of all

The Issue: Medical devices intended for use in a healthcare

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

Class II — Potential Health HazardOngoing
May 12, 2021· Stryker Medical Division of Stryker Corporation

Recalled Item: Symmetry Plus Treatment Recliner - general hospital use as a

The Issue: Medical devices intended for use in a healthcare

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

Class II — Potential Health HazardOngoing
May 12, 2021· Stryker Medical Division of Stryker Corporation

Recalled Item: GoBed II MedSurg Bed

The Issue: Medical devices intended for use in a healthcare

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

Class II — Potential Health HazardOngoing
May 12, 2021· Stryker Medical Division of Stryker Corporation

Recalled Item: IsoGel Air - support surface assists in the prevention and

The Issue: Medical devices intended for use in a healthcare

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

Class II — Potential Health HazardOngoing
May 12, 2021· Stryker Medical Division of Stryker Corporation

Recalled Item: Surgistool-intended to support a healthcare professional during surgical...

The Issue: Medical devices intended for use in a healthcare

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

Class II — Potential Health HazardOngoing
May 12, 2021· Stryker Medical Division of Stryker Corporation

Recalled Item: Electric MedSurg Bed FL23 - AC-powered adjustable hospital bed with

The Issue: Medical devices intended for use in a healthcare

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

Class II — Potential Health HazardOngoing
May 12, 2021· Stryker Medical Division of Stryker Corporation

Recalled Item: TruRize Clinical Chair - support structure that places human occupants

The Issue: Medical devices intended for use in a healthcare

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

Class II — Potential Health HazardOngoing
May 12, 2021· Stryker Medical Division of Stryker Corporation

Recalled Item: Isolibrium Support Surface - support surface assists in the prevention

The Issue: Medical devices intended for use in a healthcare

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

Class II — Potential Health HazardOngoing
May 12, 2021· Stryker Medical Division of Stryker Corporation

Recalled Item: Prime TC-transport chair intended for medical purposes to assist a

The Issue: Medical devices intended for use in a healthcare

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

Class II — Potential Health HazardOngoing
May 12, 2021· Encore Medical, LP

Recalled Item: DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus

The Issue: Packaging mixup; There is a potential that packaging

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

Class II — Potential Health HazardOngoing
May 12, 2021· Encore Medical, LP

Recalled Item: DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus

The Issue: Packaging mixup; There is a potential that packaging

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

Class II — Potential Health HazardOngoing
May 11, 2021· Exactech, Inc.

Recalled Item: Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT.

The Issue: The HAT trial contains a retaining ring that

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

Class II — Potential Health HazardCompleted
May 11, 2021· Medical Action Industries, Inc. 306

Recalled Item: novaplus

The Issue: There is a potential for flaking metal and/or

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

Class II — Potential Health HazardTerminated
May 11, 2021· Medical Action Industries, Inc. 306

Recalled Item: Medical Action INDUSTRIES INC.

The Issue: There is a potential for flaking metal and/or

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

Class II — Potential Health HazardTerminated
May 11, 2021· Medical Action Industries, Inc. 306

Recalled Item: Medical Action INDUSTRIES INC.

The Issue: There is a potential for flaking metal and/or

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

Class II — Potential Health HazardTerminated