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 33801–33820 of 38,428 recalls

February 26, 2014· Biomet, Inc.

Recalled Item: Part 475630

The Issue: Incorrect labeling on specific lots of the Intramedullary

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

Class II — Potential Health HazardTerminated
February 26, 2014· Biomet, Inc.

Recalled Item: Part 475620 Intramedullary Bone Saw CAM Assembly Size 12mm

The Issue: Incorrect labeling on specific lots of the Intramedullary

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

Class II — Potential Health HazardTerminated
February 26, 2014· Biomet, Inc.

Recalled Item: Part 475625

The Issue: Incorrect labeling on specific lots of the Intramedullary

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

Class II — Potential Health HazardTerminated
February 25, 2014· Hospira Inc.

Recalled Item: LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet

The Issue: Hospira identified an incorrect lower lid (set component)

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

Class II — Potential Health HazardTerminated
February 25, 2014· Zimmer, Inc.

Recalled Item: Natural-Knee¿/Apollo" Knee: M/B PAT SZ0 NATURAL-KNEE M/B PAT SZ1 NATURAL-KNEE

The Issue: A complaint was received for a discolored All

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

Class II — Potential Health HazardTerminated
February 25, 2014· Zimmer, Inc.

Recalled Item: Natural-Knee¿ II Posterior Stabilized (P.S.) Condylar Tibial Inserts: N-K II

The Issue: A complaint was received for a discolored All

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

Class II — Potential Health HazardTerminated
February 25, 2014· Zimmer, Inc.

Recalled Item: Natural-Knee¿ II - Unicompartmental Knee Prosthesis: CONG TIB INS SZ1/2

The Issue: A complaint was received for a discolored All

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

Class II — Potential Health HazardTerminated
February 25, 2014· Zimmer, Inc.

Recalled Item: Apollo Knee Tibial Baseplate/Knee Tibial Insert: CONG TIB INS SZ0/19MM

The Issue: A complaint was received for a discolored All

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

Class II — Potential Health HazardTerminated
February 25, 2014· Zimmer, Inc.

Recalled Item: Natural-Knee¿ N-K II DOMED ALL-POLY PAT

The Issue: A complaint was received for a discolored All

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

Class II — Potential Health HazardTerminated
February 25, 2014· Zimmer, Inc.

Recalled Item: MOST Options" System (MOST) HINGED TIB INS SZ 1 16MM

The Issue: A complaint was received for a discolored All

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

Class II — Potential Health HazardTerminated
February 25, 2014· Zimmer, Inc.

Recalled Item: Natural-Knee¿ Congruent Tibial Insert with Screw: SF-CON TIB INS LT

The Issue: A complaint was received for a discolored All

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

Class II — Potential Health HazardTerminated
February 25, 2014· Zimmer, Inc.

Recalled Item: Natural-Knee¿ II Unicompartmental Knee System: UNI ALL-POLY TIB SZ 1-7mm

The Issue: A complaint was received for a discolored All

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

Class II — Potential Health HazardTerminated
February 25, 2014· Zimmer, Inc.

Recalled Item: Natural-Knee¿ II Constrained Knee System NKII CCK TIB INS SZ00/0-L

The Issue: A complaint was received for a discolored All

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

Class II — Potential Health HazardTerminated
February 25, 2014· Zimmer, Inc.

Recalled Item: Gender Solutions" Natural-Knee¿ Flex System: N-K FLEX MBACK SZ 0

The Issue: A complaint was received for a discolored All

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

Class II — Potential Health HazardTerminated
February 25, 2014· Zimmer, Inc.

Recalled Item: Natural-Knee¿ II System ULTRA CONG INS LT SZA/9MM ULTRA CONG

The Issue: A complaint was received for a discolored All

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

Class II — Potential Health HazardTerminated
February 25, 2014· Zimmer, Inc.

Recalled Item: Apollo" Revision/Constrained Knee System: SZ0-16MM AK CCK TIB INSER SZ1-11MM

The Issue: A complaint was received for a discolored All

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

Class II — Potential Health HazardTerminated
February 25, 2014· Zimmer, Inc.

Recalled Item: Natural-Knee¿ II System: POLY ULTRA TIB LT SZ00/9M POLY ULTRA

The Issue: A complaint was received for a discolored All

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

Class II — Potential Health HazardTerminated
February 25, 2014· Zimmer, Inc.

Recalled Item: Apollo" Knee System: PS TIB INS SZ0/16MM APOLL PS TIB

The Issue: A complaint was received for a discolored All

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

Class II — Potential Health HazardTerminated
February 25, 2014· Zimmer, Inc.

Recalled Item: Apollo" Knee System: APOLLO PATELLA SZ0 28MM R

The Issue: A complaint was received for a discolored All

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

Class II — Potential Health HazardTerminated
February 24, 2014· Nico Corp.

Recalled Item: Myriad handpiece Tissue morcellator

The Issue: This recall has been initiated due to a

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

Class II — Potential Health HazardTerminated