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 30681–30700 of 38,428 recalls

April 2, 2015· Winco Mfg., LLC

Recalled Item: Winco Care Cliner X-Large - with Steel Casters Oncology

The Issue: Shipment of foam for chairs was received classified

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

Class II — Potential Health HazardTerminated
April 2, 2015· Winco Mfg., LLC

Recalled Item: Winco Designer Care Cliner w/Swing Arms - with Nylon Casters Oncology

The Issue: Shipment of foam for chairs was received classified

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

Class II — Potential Health HazardTerminated
April 2, 2015· Winco Mfg., LLC

Recalled Item: Winco Nocturnal Elite Care Cliner - with Nylon Casters Lay

The Issue: Shipment of foam for chairs was received classified

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

Class II — Potential Health HazardTerminated
April 2, 2015· Winco Mfg., LLC

Recalled Item: Winco Care Cliner X-Large - with Nylon Casters Oncology

The Issue: Shipment of foam for chairs was received classified

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

Class II — Potential Health HazardTerminated
April 2, 2015· Winco Mfg., LLC

Recalled Item: Winco Inverness 24-Hour Treatment Recliner - with Nylon Casters Lay

The Issue: Shipment of foam for chairs was received classified

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

Class II — Potential Health HazardTerminated
April 2, 2015· Winco Mfg., LLC

Recalled Item: Winco Drop Arm Care Cliner X-Large - with Nylon Casters Oncology

The Issue: Shipment of foam for chairs was received classified

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

Class II — Potential Health HazardTerminated
April 2, 2015· Winco Mfg., LLC

Recalled Item: Winco Elite Care Cliner w/Swing Away Arms X-Large - with Nylon Casters Oncology

The Issue: Shipment of foam for chairs was received classified

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

Class II — Potential Health HazardTerminated
April 2, 2015· Winco Mfg., LLC

Recalled Item: Winco Designer Care Cliner - with Nylon Casters Oncology

The Issue: Shipment of foam for chairs was received classified

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

Class II — Potential Health HazardTerminated
April 2, 2015· Maquet Cardiovascular Us Sales, Llc

Recalled Item: FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for

The Issue: In some Flow-i Anesthesia Systems, patient cassette can

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

Class I — Serious Health HazardTerminated
April 2, 2015· MELA Sciences, Inc.

Recalled Item: MelaFind Device

The Issue: The probability and histogram data within the Melafind's

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

Class II — Potential Health HazardTerminated
April 2, 2015· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Dimension EXL with LM

The Issue: Certain Dimension Integrated Chemistry Systems Instrument Power Configurations

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

Class II — Potential Health HazardTerminated
April 2, 2015· Zimmer, Inc.

Recalled Item: NexGen Augment

The Issue: The affected lot is being recalled because it

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

Class II — Potential Health HazardTerminated
April 1, 2015· Viewray Incorporated

Recalled Item: Patient Handling System (Motion Control Software)

The Issue: ViewRay received a report that the couch moved

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

Class II — Potential Health HazardTerminated
April 1, 2015· Teleflex Medical

Recalled Item: Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier

The Issue: Customer complaints were received of power to the

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

Class II — Potential Health HazardTerminated
April 1, 2015· Dako North America Inc.

Recalled Item: Test Request Distributor (TRD 1.3 and TRD 1.4)

The Issue: If a user requests slides from the LIS

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

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

Recalled Item: Reinforced Dual Lumen Cannula

The Issue: for clear extension tube to separate from

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

Class I — Serious Health HazardTerminated
March 30, 2015· Merge Healthcare, Inc.

Recalled Item: Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit)

The Issue: The units may display the alarm "sampling line

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

Class II — Potential Health HazardTerminated
March 30, 2015· Nipro Medical Corporation

Recalled Item: NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with

The Issue: Blood foaming was found during evaluation of the

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

Class II — Potential Health HazardTerminated
March 30, 2015· Integra LifeSciences Corp. d.b.a. Integra Pain Management

Recalled Item: Integra Long Epidural Steroid Injection Needle (Tuohy Needle)

The Issue: A single lot of 18 Gauge, 3.5 inch

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

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

Recalled Item: OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO

The Issue: for clear extension tube to separate from

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

Class I — Serious Health HazardTerminated