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 20921–20940 of 38,428 recalls

May 14, 2018· Maquet Cardiopulmonary Ag

Recalled Item: Aortic Arterial Cannula 22 Fr (O.D.)

The Issue: This lot of arterial cannula may have been

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

Class II — Potential Health HazardTerminated
May 14, 2018· Maquet Cardiopulmonary Ag

Recalled Item: Aortic Arterial Cannula 20 Fr (O.D.)

The Issue: This lot of arterial cannula may have been

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

Class II — Potential Health HazardTerminated
May 14, 2018· Maquet Cardiopulmonary Ag

Recalled Item: Aortic Arterial Cannula 24 Fr (O.D.)

The Issue: This lot of arterial cannula may have been

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

Class II — Potential Health HazardTerminated
May 11, 2018· Smith & Nephew, Inc.

Recalled Item: Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm

The Issue: The affected devices are manufactured to the same

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

Class II — Potential Health HazardTerminated
May 11, 2018· Arrow International Inc

Recalled Item: Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter

The Issue: The recalling firm has received complaints related to

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

Class II — Potential Health HazardTerminated
May 11, 2018· Olympus Corporation of the Americas

Recalled Item: Olympus JF-140F duodenoscopes (Model NumberJF-140F)

The Issue: Issuance of validated, new reprocessing procedures. This corrective

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

Class II — Potential Health HazardTerminated
May 11, 2018· Smith & Nephew, Inc.

Recalled Item: Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm

The Issue: The affected devices are manufactured to the same

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

Class II — Potential Health HazardTerminated
May 11, 2018· Olympus Corporation of the Americas

Recalled Item: Olympus JF-160F duodenoscopes (Model NumberJF-160F)

The Issue: Issuance of validated, new reprocessing procedures. The new

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

Class II — Potential Health HazardTerminated
May 11, 2018· Zimmer Biomet, Inc.

Recalled Item: Vanguard Knee System PS Tibial Bearing

The Issue: The label master file was errantly set up

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

Class II — Potential Health HazardTerminated
May 11, 2018· Olsen Medical

Recalled Item: Symmetry Olsen bipolar cord: (a) Bipolar Cord

The Issue: Products may encroach into the sterile pouch seal

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

Class II — Potential Health HazardTerminated
May 11, 2018· Olsen Medical

Recalled Item: Symmetry Olsen Monopolar Pencil: (a) Button Switchpen

The Issue: Products may encroach into the sterile pouch seal

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

Class II — Potential Health HazardTerminated
May 11, 2018· Olsen Medical

Recalled Item: Symmetry Olsen monopolar forceps: (a) Insulated Potts-Smith Forceps 8" (20.3cm)

The Issue: Products may encroach into the sterile pouch seal

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

Class II — Potential Health HazardTerminated
May 11, 2018· Olsen Medical

Recalled Item: Symmetry Olsen monopolar cord: (a) Monopolar Cord

The Issue: Products may encroach into the sterile pouch seal

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

Class II — Potential Health HazardTerminated
May 11, 2018· Olsen Medical

Recalled Item: Symmetry Olsen bipolar forceps: (a1) Insulated Irrigating Bayonet Forceps 6.25"

The Issue: Products may encroach into the sterile pouch seal

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

Class II — Potential Health HazardTerminated
May 10, 2018· Smiths Medical ASD Inc.

Recalled Item: medfusion Stopcock

The Issue: Product has a lack of sterility assurance

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

Class II — Potential Health HazardTerminated
May 10, 2018· Zimmer Dental Inc

Recalled Item: Outer Package Label: Tapered Screw-Vent Implant System

The Issue: Dental implants have incorrect item/lot numbers and size

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

Class II — Potential Health HazardTerminated
May 10, 2018· Mako Surgical Corporation

Recalled Item: Rio System Irrigation Clip - Catalog # 111690 Product Usage:

The Issue: Out of tolerance

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

Class II — Potential Health HazardTerminated
May 10, 2018· Life Technologies, Corp.

Recalled Item: GIBCO CTS AIM V Serum-Free Media (SFM)

The Issue: It has been determined that the fill port

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

Class II — Potential Health HazardTerminated
May 10, 2018· Life Technologies, Corp.

Recalled Item: Gibco Dulbecco's Modified Eagle Medium (DMEM)

The Issue: It has been determined that the fill port

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

Class II — Potential Health HazardTerminated
May 10, 2018· Life Technologies, Corp.

Recalled Item: Gibco CTS OpTmizer T Cell Expansion Serum Free Medium

The Issue: It has been determined that the fill port

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

Class II — Potential Health HazardTerminated