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 33581–33600 of 38,428 recalls

March 20, 2014· Aspen Surgical Products, Inc.

Recalled Item: 10FR Drain Kit

The Issue: The recall has been initiated due to a

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

Class II — Potential Health HazardTerminated
March 20, 2014· Aspen Surgical Products, Inc.

Recalled Item: 10mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator

The Issue: The recall has been initiated due to a

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

Class II — Potential Health HazardTerminated
March 20, 2014· Aspen Surgical Products, Inc.

Recalled Item: 19FR Drain Kit Flat Full Perforated with Trocar

The Issue: The recall has been initiated due to a

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

Class II — Potential Health HazardTerminated
March 20, 2014· Aspen Surgical Products, Inc.

Recalled Item: 19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb

The Issue: The recall has been initiated due to a

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

Class II — Potential Health HazardTerminated
March 19, 2014· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Dimension Vista¿ CSA and CSAE The Cyclosporine method is an

The Issue: A complaint was received of Dimension Vista¿ CSA

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

Class II — Potential Health HazardTerminated
March 19, 2014· Zimmer, Inc.

Recalled Item: Tennis Elbow Support

The Issue: During a transfer of products from a recently

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

Class II — Potential Health HazardTerminated
March 19, 2014· Zimmer, Inc.

Recalled Item: Hinged Knee Support***LATEX FREE" Product Usage: Provide added lateral stability

The Issue: During a transfer of products from a recently

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

Class II — Potential Health HazardTerminated
March 19, 2014· Zimmer, Inc.

Recalled Item: Cartilage Knee Brace***LATEX FREE" Product Usage: Used in the treatment

The Issue: During a transfer of products from a recently

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

Class II — Potential Health HazardTerminated
March 19, 2014· RM Temena GmbH

Recalled Item: Ultrasound USB needles

The Issue: Ultrasound needles may be defective and leak at

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

Class II — Potential Health HazardTerminated
March 19, 2014· Zimmer, Inc.

Recalled Item: DROP LOK" Knee Brace***LATEX FREE" Product Usage: Used in the treatment

The Issue: During a transfer of products from a recently

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

Class II — Potential Health HazardTerminated
March 19, 2014· RM Temena GmbH

Recalled Item: Ultrasound needles

The Issue: Ultrasound needles may be defective and leak at

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

Class II — Potential Health HazardTerminated
March 19, 2014· Biorep Technologies

Recalled Item: Joseph Lamelas Atrial Lift System

The Issue: The support arm attached with an adhesive to

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

Class II — Potential Health HazardTerminated
March 19, 2014· CareFusion 303, Inc.

Recalled Item: SmartSite Extension Set

The Issue: Disconnections and leakages at the connection of the

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

Class II — Potential Health HazardTerminated
March 18, 2014· Nanosphere, Inc.

Recalled Item: Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit

The Issue: Nanosphere has recieved reports related to an unacceptable

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

Class III — Low RiskTerminated
March 18, 2014· SCM True Air Technologies LLC

Recalled Item: JK Bariatric Beds

The Issue: The firm is recalling the products due to

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

Class II — Potential Health HazardTerminated
March 18, 2014· SCM True Air Technologies LLC

Recalled Item: MaXair True Low Air Loss Mattress Replacement System

The Issue: The firm is recalling the products due to

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

Class II — Potential Health HazardTerminated
March 18, 2014· SCM True Air Technologies LLC

Recalled Item: ECATS E 850 Bariatric Bed

The Issue: The firm is recalling the products due to

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

Class II — Potential Health HazardTerminated
March 18, 2014· Energizer Personal Care

Recalled Item: Playtex Nurser Deluxe Double Electric Breast Pump

The Issue: Some of the power adapters outer casings may

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

Class II — Potential Health HazardTerminated
March 18, 2014· Stryker Instruments Div. of Stryker Corporation

Recalled Item: 2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade

The Issue: Stryker Instruments is voluntarily recalling the single use

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

Class II — Potential Health HazardTerminated
March 17, 2014· Arjo Hospital Equipment AB

Recalled Item: ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients

The Issue: There is a low but existing entrapment risk

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

Class II — Potential Health HazardTerminated