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 9841–9860 of 38,428 recalls

September 28, 2022· Cardinal Health 200, LLC

Recalled Item: Cardinal Health Reusable Gel Pack

The Issue: Users are being informed that the product should

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

Class II — Potential Health HazardOngoing
September 28, 2022· X-NAV Technologies, LLC

Recalled Item: X-Guide X-Mark Probe Tool -used for registering edentulous patients to

The Issue: Product missing one of two welds connecting the

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

Class II — Potential Health HazardOngoing
September 28, 2022· Cardinal Health 200, LLC

Recalled Item: Cardinal Health INSULATED GEL PACK REUSABLE

The Issue: Users are being informed that the product should

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

Class II — Potential Health HazardOngoing
September 28, 2022· Cardinal Health 200, LLC

Recalled Item: Cardinal Health INSULATED GEL PACK REUSABLE

The Issue: Users are being informed that the product should

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

Class II — Potential Health HazardOngoing
September 28, 2022· Cardinal Health 200, LLC

Recalled Item: Cardinal Health GEL PACK REUSABLE

The Issue: Users are being informed that the product should

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

Class II — Potential Health HazardOngoing
September 28, 2022· Cardinal Health 200, LLC

Recalled Item: Cardinal Health HOT AND COLD GEL PACK REUSABLE

The Issue: Users are being informed that the product should

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

Class II — Potential Health HazardOngoing
September 28, 2022· Cardinal Health 200, LLC

Recalled Item: Cardinal Health INSULATED GEL PACK REUSABLE

The Issue: Users are being informed that the product should

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

Class II — Potential Health HazardOngoing
September 28, 2022· iRhythm Technologies, Inc.

Recalled Item: Zio AT Clinical Manual

The Issue: Ambulatory ECG monitoring system labeling update: 1) Clinically

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

Class II — Potential Health HazardOngoing
September 27, 2022· Synthes (USA) Products LLC

Recalled Item: SPEED 9X10X10mm Continuous Compression Implant

The Issue: The subject products are being recalled because they

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

Class II — Potential Health HazardOngoing
September 27, 2022· Synthes (USA) Products LLC

Recalled Item: DePuy Synthes Hammertoe Continuous Compression Implants

The Issue: The subject products are being recalled because they

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

Class II — Potential Health HazardOngoing
September 27, 2022· Synthes (USA) Products LLC

Recalled Item: SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit

The Issue: The subject products are being recalled because they

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

Class II — Potential Health HazardOngoing
September 27, 2022· Synthes (USA) Products LLC

Recalled Item: SPEED 15X12X12mm Continuous Compression Implant

The Issue: The subject products are being recalled because they

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

Class II — Potential Health HazardOngoing
September 26, 2022· Carefusion 2200 Inc

Recalled Item: CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM)

The Issue: Genesis STERRAD Reusable Rigid Sterilization Containers have not

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

Class II — Potential Health HazardOngoing
September 26, 2022· Carefusion 2200 Inc

Recalled Item: CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 8"

The Issue: Genesis STERRAD Reusable Rigid Sterilization Containers have not

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

Class II — Potential Health HazardOngoing
September 26, 2022· Carefusion 2200 Inc

Recalled Item: CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM)

The Issue: Genesis STERRAD Reusable Rigid Sterilization Containers have not

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

Class II — Potential Health HazardOngoing
September 26, 2022· Carefusion 2200 Inc

Recalled Item: CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 6"

The Issue: Genesis STERRAD Reusable Rigid Sterilization Containers have not

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

Class II — Potential Health HazardOngoing
September 26, 2022· Carefusion 2200 Inc

Recalled Item: CareFusion V.Mueller GENESIS QTR-LENGTH CONTAINER 12 X 8" (30.3X20.3CM) 4"

The Issue: Genesis STERRAD Reusable Rigid Sterilization Containers have not

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

Class II — Potential Health HazardOngoing
September 26, 2022· Carefusion 2200 Inc

Recalled Item: CareFusion V.Mueller GENESIS SMALL CONTAINER 21 X 7" (53.3 X

The Issue: Genesis STERRAD Reusable Rigid Sterilization Containers have not

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

Class II — Potential Health HazardOngoing
September 26, 2022· Carefusion 2200 Inc

Recalled Item: CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 4"

The Issue: Genesis STERRAD Reusable Rigid Sterilization Containers have not

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

Class II — Potential Health HazardOngoing
September 26, 2022· Carefusion 2200 Inc

Recalled Item: CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3"

The Issue: Genesis STERRAD Reusable Rigid Sterilization Containers have not

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

Class II — Potential Health HazardOngoing