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 35621–35640 of 38,428 recalls

May 23, 2013· Prism Medical Services USA

Recalled Item: BC Hammock Mesh Sling (Junior)

The Issue: The product does not meet the firm's size

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

Class II — Potential Health HazardTerminated
May 23, 2013· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile

The Issue: Based on an accelerated aging test for this

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

Class II — Potential Health HazardTerminated
May 23, 2013· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker Instruments 0400-760-000 T4 Toga

The Issue: Based on an accelerated aging test for this

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

Class II — Potential Health HazardTerminated
May 23, 2013· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile

The Issue: Based on an accelerated aging test for this

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

Class II — Potential Health HazardTerminated
May 23, 2013· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker Instruments 0400-770-000 T4 Toga

The Issue: Based on an accelerated aging test for this

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

Class II — Potential Health HazardTerminated
May 23, 2013· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile

The Issue: Based on an accelerated aging test for this

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

Class II — Potential Health HazardTerminated
May 23, 2013· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker Instruments 0400-840-000 T4 Toga

The Issue: Based on an accelerated aging test for this

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

Class II — Potential Health HazardTerminated
May 23, 2013· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away

The Issue: Based on an accelerated aging test for this

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

Class II — Potential Health HazardTerminated
May 23, 2013· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut

The Issue: Based on an accelerated aging test for this

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

Class II — Potential Health HazardTerminated
May 23, 2013· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker Instruments 0400-850-000 T4 Toga

The Issue: Based on an accelerated aging test for this

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

Class II — Potential Health HazardTerminated
May 23, 2013· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away

The Issue: Based on an accelerated aging test for this

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

Class II — Potential Health HazardTerminated
May 23, 2013· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away

The Issue: Based on an accelerated aging test for this

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

Class II — Potential Health HazardTerminated
May 23, 2013· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker Instruments 0400-830-000 T4 Toga

The Issue: Based on an accelerated aging test for this

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

Class II — Potential Health HazardTerminated
May 23, 2013· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker Instruments0400-750-000 T4 Toga

The Issue: Based on an accelerated aging test for this

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

Class II — Potential Health HazardTerminated
May 23, 2013· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile

The Issue: Based on an accelerated aging test for this

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

Class II — Potential Health HazardTerminated
May 23, 2013· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker Instruments 0400-850-000S2 T4 Toga

The Issue: Based on an accelerated aging test for this

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

Class II — Potential Health HazardTerminated
May 23, 2013· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties

The Issue: Based on an accelerated aging test for this

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

Class II — Potential Health HazardTerminated
May 22, 2013· Elekta, Inc.

Recalled Item: Monaco RTP System Radiation Therapy Treatment Planning System. Radiation...

The Issue: Patient needs to be positioned as indicated by

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

Class II — Potential Health HazardTerminated
May 21, 2013· Baxter Healthcare Corp.

Recalled Item: Baxter

The Issue: leaking pouches

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

Class II — Potential Health HazardTerminated
May 21, 2013· Stryker Howmedica Osteonics Corp.

Recalled Item: GAMMA3 System Long Nail Kit

The Issue: Stryker Osteosynthesis has become aware that LEFT GAMMA3

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

Class II — Potential Health HazardTerminated