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 21441–21460 of 38,428 recalls

March 28, 2018· Zimmer Biomet, Inc.

Recalled Item: Gentle Threads

The Issue: Specific lots of the device were overexposed during

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

Class II — Potential Health HazardTerminated
March 28, 2018· Zimmer Biomet, Inc.

Recalled Item: Gentle Threads

The Issue: Specific lots of the device were overexposed during

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

Class II — Potential Health HazardTerminated
March 28, 2018· Cardinal Health 200, LLC

Recalled Item: Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner

The Issue: products may be missing a one-way valve on

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

Class II — Potential Health HazardTerminated
March 28, 2018· Ace Surgical Supply Co., Inc.

Recalled Item: Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU

The Issue: The product inside the package is incorrect. A

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

Class II — Potential Health HazardTerminated
March 27, 2018· Trilliant Surgical Ltd.

Recalled Item: Ratcheting Cannulated Driver Handle

The Issue: Firm is voluntarily recalling cannulated driver handles (210-00-003

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

Class II — Potential Health HazardTerminated
March 27, 2018· Trilliant Surgical Ltd.

Recalled Item: Cannulated Driver Handle

The Issue: Firm is voluntarily recalling cannulated driver handles (210-00-003

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

Class II — Potential Health HazardTerminated
March 27, 2018· Siemens Healthcare Diagnostics, Inc.

Recalled Item: ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use

The Issue: Urea Nitrogen reagent kit demonstrated an increased incidence

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

Class II — Potential Health HazardTerminated
March 27, 2018· Siemens Medical Solutions USA, Inc

Recalled Item: Syngo.Via VB20A model 1049610

The Issue: Functionality in the report sections "Findings Information" and

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

Class II — Potential Health HazardTerminated
March 27, 2018· Teleflex Medical Europe Ltd

Recalled Item: Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port

The Issue: These one-way valves may disconnect at the joint

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

Class II — Potential Health HazardTerminated
March 26, 2018· Ethicon Endo-Surgery Inc

Recalled Item: 5mm Endopath Xcel with Optiview Technology

The Issue: Use of the product with insufficient lubrication may

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

Class II — Potential Health HazardTerminated
March 26, 2018· Ethicon Endo-Surgery Inc

Recalled Item: 5mm Endopath Xcel with Optiview Technology

The Issue: Use of the product with insufficient lubrication may

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

Class II — Potential Health HazardTerminated
March 26, 2018· Ethicon Endo-Surgery Inc

Recalled Item: 5mm Endopath Xcel with Optiview Technology

The Issue: Use of the product with insufficient lubrication may

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

Class II — Potential Health HazardTerminated
March 26, 2018· Ethicon Endo-Surgery Inc

Recalled Item: 5mm Endopath Xcel with Optiview Technology

The Issue: Use of the product with insufficient lubrication may

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

Class II — Potential Health HazardTerminated
March 26, 2018· Ethicon Endo-Surgery Inc

Recalled Item: 5mm Endopath Xcel with Optiview Technology

The Issue: Use of the product with insufficient lubrication may

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

Class II — Potential Health HazardTerminated
March 26, 2018· Beckman Coulter Inc.

Recalled Item: BECKMAN COULTER MicroScan MICroSTREP Plus Panel

The Issue: Beckman Coulter has received customer complaints of lowered

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

Class II — Potential Health HazardTerminated
March 26, 2018· Tornier, Inc

Recalled Item: AEQUALIS HUMERAL NAIL DRILL BIT

The Issue: Drill bit tips without new BargerGard tip protector

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

Class II — Potential Health HazardTerminated
March 26, 2018· Philips Medical Systems Nederlands

Recalled Item: MultiDiagnostic-Eleva with Flat Detector 708035 As a multifunctional...

The Issue: The fixation of the upper and lower tilt

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

Class II — Potential Health HazardTerminated
March 26, 2018· Philips Medical Systems Nederlands

Recalled Item: Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As

The Issue: The fixation of the upper and lower tilt

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

Class II — Potential Health HazardTerminated
March 26, 2018· Philips Medical Systems Nederlands

Recalled Item: 708033 URODiagnost As a multifunctional universal imaging application system

The Issue: The fixation of the upper and lower tilt

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

Class II — Potential Health HazardTerminated
March 26, 2018· Philips Medical Systems Nederlands

Recalled Item: MultiDiagnost Eleva 708036 As a multifunctional universal imaging...

The Issue: The fixation of the upper and lower tilt

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

Class II — Potential Health HazardTerminated