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 15361–15380 of 38,428 recalls

April 6, 2020· Skeletal Kinetics, Llc

Recalled Item: CRANIOSCULPT FLOW

The Issue: Bone void filler kits may not maintain its

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

Class II — Potential Health HazardTerminated
April 6, 2020· Skeletal Kinetics, Llc

Recalled Item: SKAFFOLD FLOW (MX) 5CC. Product Number: SKMX-FL05

The Issue: Bone void filler kits may not maintain its

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

Class II — Potential Health HazardTerminated
April 6, 2020· Skeletal Kinetics, Llc

Recalled Item: CRANIOSCULPT FLOW

The Issue: Bone void filler kits may not maintain its

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

Class II — Potential Health HazardTerminated
April 6, 2020· Skeletal Kinetics, Llc

Recalled Item: OSTEOVATION IMPACT 10CC and OSTEOVATION

The Issue: Bone void filler kits may not maintain its

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

Class II — Potential Health HazardTerminated
April 6, 2020· Skeletal Kinetics, Llc

Recalled Item: OSTEOVATION RMX 5CC. Product Number: 390-6001

The Issue: Bone void filler kits may not maintain its

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

Class II — Potential Health HazardTerminated
April 6, 2020· Skeletal Kinetics, Llc

Recalled Item: ACUMED CALLOS INJECT 10CC. Product Number: 65-0010-S

The Issue: Bone void filler kits may not maintain its

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

Class II — Potential Health HazardTerminated
April 6, 2020· Skeletal Kinetics, Llc

Recalled Item: ACUMED CALLOS INJECT 3CC. Product Number: 65-0003-S

The Issue: Bone void filler kits may not maintain its

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

Class II — Potential Health HazardTerminated
April 6, 2020· Skeletal Kinetics, Llc

Recalled Item: SKAFFOLD CMF IMPRESS (MP)

The Issue: Bone void filler kits may not maintain its

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

Class II — Potential Health HazardTerminated
April 6, 2020· Skeletal Kinetics, Llc

Recalled Item: SKAFFOLD FLOW

The Issue: Bone void filler kits may not maintain its

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

Class II — Potential Health HazardTerminated
April 6, 2020· Skeletal Kinetics, Llc

Recalled Item: OSTEOVATION

The Issue: Bone void filler kits may not maintain its

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

Class II — Potential Health HazardTerminated
April 6, 2020· Skeletal Kinetics, Llc

Recalled Item: CRANIOSCULPT C

The Issue: Bone void filler kits may not maintain its

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

Class II — Potential Health HazardTerminated
April 6, 2020· Skeletal Kinetics, Llc

Recalled Item: OSTEOVATIONEX 2CC INJECT FORMULA. Product Number: 390-0002

The Issue: Bone void filler kits may not maintain its

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

Class II — Potential Health HazardTerminated
April 6, 2020· Skeletal Kinetics, Llc

Recalled Item: CRANIOSCULPT C

The Issue: Bone void filler kits may not maintain its

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

Class II — Potential Health HazardTerminated
April 6, 2020· Skeletal Kinetics, Llc

Recalled Item: CRANIOSCULPT C

The Issue: Bone void filler kits may not maintain its

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

Class II — Potential Health HazardTerminated
April 6, 2020· Skeletal Kinetics, Llc

Recalled Item: CRANIOSCULPT FLOW

The Issue: Bone void filler kits may not maintain its

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

Class II — Potential Health HazardTerminated
April 6, 2020· Skeletal Kinetics, Llc

Recalled Item: MEDTRONIC BONE VOID FILLER

The Issue: Bone void filler kits may not maintain its

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

Class II — Potential Health HazardTerminated
April 6, 2020· Skeletal Kinetics, Llc

Recalled Item: CRANIOSCULPT

The Issue: Bone void filler kits may not maintain its

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

Class II — Potential Health HazardTerminated
April 6, 2020· Skeletal Kinetics, Llc

Recalled Item: CRANIOSCULPT

The Issue: Bone void filler kits may not maintain its

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

Class II — Potential Health HazardTerminated
April 6, 2020· Skeletal Kinetics, Llc

Recalled Item: OSTEOVATIONEX

The Issue: Bone void filler kits may not maintain its

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

Class II — Potential Health HazardTerminated
April 6, 2020· Skeletal Kinetics, Llc

Recalled Item: CRANIOSCULPT FLOW

The Issue: Bone void filler kits may not maintain its

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

Class II — Potential Health HazardTerminated