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 30701–30720 of 38,428 recalls

March 30, 2015· Baylis Medical Corp *

Recalled Item: ProTrack Microcatheter

The Issue: Baylis Medical Company is recalling two lots of

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

Class II — Potential Health HazardTerminated
March 30, 2015· VasoNova, Inc.

Recalled Item: VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number

The Issue: A limited number of VPS G4 Consoles are

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

Class II — Potential Health HazardTerminated
March 27, 2015· Becton Dickinson & Co.

Recalled Item: BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II)

The Issue: BD has confirmed that one lot of TSA

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

Class III — Low RiskTerminated
March 27, 2015· Visicu, Inc.

Recalled Item: The eCareManager system. Software intended for use in data collection

The Issue: A software defect may cause incorrect medication order

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

Class II — Potential Health HazardTerminated
March 27, 2015· Amtryke LLC

Recalled Item: AmTryke Model 1424 Community Cruiser Hand Cycle. Therapeutic tricycle.

The Issue: Product is being recalled due to complaints of

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

Class II — Potential Health HazardTerminated
March 27, 2015· Biomerieux Inc

Recalled Item: Vitek 2 AST-YS07 967

The Issue: The test kits have Out-of-Range-Low (OORL) Flucytosine QC

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

Class II — Potential Health HazardTerminated
March 27, 2015· Biomerieux Inc

Recalled Item: Vitek 2 AST-YS01 108

The Issue: The test kits have Out-of-Range-Low (OORL) Flucytosine QC

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

Class II — Potential Health HazardTerminated
March 27, 2015· Biomerieux Inc

Recalled Item: Vitek 2 AST-YS06 610

The Issue: The test kits have Out-of-Range-Low (OORL) Flucytosine QC

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

Class II — Potential Health HazardTerminated
March 27, 2015· B. Braun Medical, Inc.

Recalled Item: CONTIPLEX Continuous Peripheral Nerve Block Tray

The Issue: There is a potential for a hole to

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

Class II — Potential Health HazardTerminated
March 26, 2015· Diamedix Corporation

Recalled Item: Diamedix Is-CMV IgG Test Kit

The Issue: Product contained an incorrect substrate

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

Class II — Potential Health HazardTerminated
March 26, 2015· Olympus America Inc.

Recalled Item: EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has

The Issue: New and validated reprocessing procedures have been issued

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

Class II — Potential Health HazardTerminated
March 26, 2015· Handicare USA, Inc.

Recalled Item: ReTurn belt

The Issue: Complaints were received that the heat-welded seam on

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

Class II — Potential Health HazardTerminated
March 26, 2015· Stryker Instruments Div. of Stryker Corporation

Recalled Item: 3/16 in. Double Trocar with Wound Drain Curved Trocar with

The Issue: Stryker Instruments is voluntarily recalling the CBCII Wound

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

Class II — Potential Health HazardTerminated
March 26, 2015· Stryker Instruments Div. of Stryker Corporation

Recalled Item: 1/8 in. Double Trocar with Wound Drain Curved Trocar with

The Issue: Stryker Instruments is voluntarily recalling the CBCII Wound

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

Class II — Potential Health HazardTerminated
March 26, 2015· Stryker Instruments Div. of Stryker Corporation

Recalled Item: 3/16 in. Round Drain with Trocar Curved Trocar with Wound

The Issue: Stryker Instruments is voluntarily recalling the CBCII Wound

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

Class II — Potential Health HazardTerminated
March 26, 2015· Stryker Instruments Div. of Stryker Corporation

Recalled Item: 3/16 in. Trocar with Single Drain Curved Trocar with Wound

The Issue: Stryker Instruments is voluntarily recalling the CBCII Wound

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

Class II — Potential Health HazardTerminated
March 26, 2015· Stryker Instruments Div. of Stryker Corporation

Recalled Item: 1/4 in. Trocar with Single Drain Curved Trocar with Wound

The Issue: Stryker Instruments is voluntarily recalling the CBCII Wound

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

Class II — Potential Health HazardTerminated
March 26, 2015· Stryker Instruments Div. of Stryker Corporation

Recalled Item: 1/4 in. Curved Trocar with Wound Drain Curved Trocar with

The Issue: Stryker Instruments is voluntarily recalling the CBCII Wound

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

Class II — Potential Health HazardTerminated
March 26, 2015· Stryker Instruments Div. of Stryker Corporation

Recalled Item: 1/8 in. Trocar with Single Drain Curved Trocar with Wound

The Issue: Stryker Instruments is voluntarily recalling the CBCII Wound

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

Class II — Potential Health HazardTerminated
March 26, 2015· Stryker Instruments Div. of Stryker Corporation

Recalled Item: 1/8 in. Curved Trocar with Wound Drain Curved Trocar with

The Issue: Stryker Instruments is voluntarily recalling the CBCII Wound

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

Class II — Potential Health HazardTerminated