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 12761–12780 of 38,428 recalls

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: 11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK.

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 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: 10G CEMENT DELIVERY 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: 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES

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: 11G DIAMOND 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: 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: 10G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). 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 Bipedicular 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: 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: 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
March 25, 2021· Zavation

Recalled Item: InterV CurvePlus 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: 11G 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: ZVplasty Direct Access Beveled 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: ZVplasty 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 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: VERTEBREX SINGLE BALLOON 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: 10G 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: 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES 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