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 12801–12820 of 38,428 recalls

March 25, 2021· Zavation

Recalled Item: 10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.

The Issue: Products distributed as sterile may not have been

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

Class II — Potential Health HazardTerminated
March 25, 2021· Zavation

Recalled Item: ZVplasty 10G

The Issue: Products distributed as sterile may not have been

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

Class II — Potential Health HazardTerminated
March 25, 2021· Zavation

Recalled Item: ZVplasty Direct Unipedicular Bone Access Kit with Drill

The Issue: Products distributed as sterile may not have been

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

Class II — Potential Health HazardTerminated
March 25, 2021· Zavation

Recalled Item: ZVplasty Direct Access Bevel Tip Trocar

The Issue: Products distributed as sterile may not have been

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

Class II — Potential Health HazardTerminated
March 25, 2021· Zavation

Recalled Item: 10 GAUGE DIRECT UNILATERAL STYLET (1 X DIAMOND 1 X

The Issue: Products distributed as sterile may not have been

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

Class II — Potential Health HazardTerminated
March 25, 2021· Zavation

Recalled Item: ZVplasty Direct Access Diamond Tip Trocar

The Issue: Products distributed as sterile may not have been

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

Class II — Potential Health HazardTerminated
March 25, 2021· Zavation

Recalled Item: 10 GAUGE DIRECT ACCESS DIAMOND TIP

The Issue: Products distributed as sterile may not have been

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

Class II — Potential Health HazardTerminated
March 25, 2021· Zavation

Recalled Item: 10G COAXIAL CANNULA WITH TUOHY CONNECTION STERILE. For use in

The Issue: Products distributed as sterile may not have been

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

Class II — Potential Health HazardTerminated
March 25, 2021· Zavation

Recalled Item: ZVplasty System

The Issue: Products distributed as sterile may not have been

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

Class II — Potential Health HazardTerminated
March 25, 2021· Zavation

Recalled Item: InterV

The Issue: Products distributed as sterile may not have been

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

Class II — Potential Health HazardTerminated
March 25, 2021· Zavation

Recalled Item: OsteoFlex Cement and Mixing System

The Issue: Products distributed as sterile may not have been

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

Class II — Potential Health HazardTerminated
March 25, 2021· Zavation

Recalled Item: 11G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.

The Issue: Products distributed as sterile may not have been

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

Class II — Potential Health HazardTerminated
March 25, 2021· Zavation

Recalled Item: InterV 10G Bone Access Tools/Kit

The Issue: Products distributed as sterile may not have been

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

Class II — Potential Health HazardTerminated
March 25, 2021· Zavation

Recalled Item: ZVplasty Direct Bipedicular Bone Access Kit with Drill

The Issue: Products distributed as sterile may not have been

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

Class II — Potential Health HazardTerminated
March 25, 2021· Zavation

Recalled Item: 10 G Coxaxial Cannula with Tuohy Connection

The Issue: Products distributed as sterile may not have been

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

Class II — Potential Health HazardTerminated
March 25, 2021· Zavation

Recalled Item: 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL)

The Issue: Products distributed as sterile may not have been

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

Class II — Potential Health HazardTerminated
March 25, 2021· Zavation

Recalled Item: 10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.

The Issue: Products distributed as sterile may not have been

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

Class II — Potential Health HazardTerminated
March 25, 2021· Zavation

Recalled Item: CEMIX - CEMENT MIXING SYSTEM STERILE

The Issue: Products distributed as sterile may not have been

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

Class II — Potential Health HazardTerminated
March 25, 2021· Zavation

Recalled Item: ZVplasty Cement Delivery Cannula

The Issue: Products distributed as sterile may not have been

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

Class II — Potential Health HazardTerminated
March 25, 2021· Zavation

Recalled Item: ZVplasty

The Issue: Products distributed as sterile may not have been

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

Class II — Potential Health HazardTerminated