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 22641–22660 of 38,428 recalls

October 19, 2017· Datascope Corporation

Recalled Item: BEQ-TOP 8504 1/4X1/4 PACK W/QP

The Issue: The Better Bladder device provided as part of

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

Class II — Potential Health HazardTerminated
October 19, 2017· Datascope Corporation

Recalled Item: Small Patient ECC Pack BEQ-TOP 22301

The Issue: The Better Bladder device provided as part of

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

Class II — Potential Health HazardTerminated
October 19, 2017· Datascope Corporation

Recalled Item: BEQ-TOP 50900 Custom ECC Pack-Neonatal 1/4

The Issue: The Better Bladder device provided as part of

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

Class II — Potential Health HazardTerminated
October 19, 2017· Datascope Corporation

Recalled Item: BEQ-TOP 50903 Custom ECC Pack-Pedriatric

The Issue: The Better Bladder device provided as part of

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

Class II — Potential Health HazardTerminated
October 19, 2017· Datascope Corporation

Recalled Item: BEQ-TOP 33500 3/8" ECC PACK

The Issue: The Better Bladder device provided as part of

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

Class II — Potential Health HazardTerminated
October 19, 2017· Datascope Corporation

Recalled Item: BEQ-T 25501 3/8" Better Bladder Pack

The Issue: The Better Bladder device provided as part of

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

Class II — Potential Health HazardTerminated
October 19, 2017· Johnson & Johnson Vision Care, Inc.

Recalled Item: ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR

The Issue: Some contact lenses were associated with complaints of

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

Class II — Potential Health HazardTerminated
October 19, 2017· Johnson & Johnson Vision Care, Inc.

Recalled Item: ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS

The Issue: Some contact lenses were associated with complaints of

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

Class II — Potential Health HazardTerminated
October 19, 2017· Johnson & Johnson Vision Care, Inc.

Recalled Item: 1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses

The Issue: Some contact lenses were associated with complaints of

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

Class II — Potential Health HazardTerminated
October 19, 2017· Ion Beam Applications S.A.

Recalled Item: Proteus 235

The Issue: Range for the same energy could be different

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

Class II — Potential Health HazardTerminated
October 19, 2017· Cook Inc.

Recalled Item: Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended...

The Issue: Cook has identified that the affected lots may

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

Class II — Potential Health HazardTerminated
October 19, 2017· Cook Inc.

Recalled Item: Percutaneous Gastrojejunostomy Set Product Usage: Intended for the...

The Issue: Cook has identified that the affected lots may

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

Class II — Potential Health HazardTerminated
October 19, 2017· Cook Inc.

Recalled Item: Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the...

The Issue: Cook has identified that the affected lots may

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

Class II — Potential Health HazardTerminated
October 19, 2017· Philips Electronics North America Corporation

Recalled Item: CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost...

The Issue: The tube adapter-plate green/yellow protective earthing (PE) wire

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

Class II — Potential Health HazardTerminated
October 18, 2017· Bioseal Corporation

Recalled Item: Custom surgical kits labeled as follows: (a) Suture Removal Set

The Issue: Custom surgical kits contain Aplicare Providone Iodine Prep

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

Class II — Potential Health HazardCompleted
October 18, 2017· BioMerieux SA

Recalled Item: NucliSENS Lysis Buffer Extended lot for RES 76675

The Issue: Elute may become colored due to the residual

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

Class II — Potential Health HazardTerminated
October 18, 2017· Teleflex Medical

Recalled Item: Teleflex(R) Percuvance(TM) Percutaneous Surgical System

The Issue: Teleflex is recalling these products because the jaws

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

Class II — Potential Health HazardTerminated
October 17, 2017· Angiodynamics Inc. (Navilyst Medical Inc.)

Recalled Item: Xcela PICC with PASV Valve Technology/Kit 5 F-55cm

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
October 17, 2017· Southmedic, Inc.

Recalled Item: Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8

The Issue: for loose or missing CO2 diffusers which

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

Class II — Potential Health HazardTerminated
October 17, 2017· Ion Beam Applications S.A.

Recalled Item: Proteus 235

The Issue: IBA identified incorrect screw holes depth in graphite

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

Class II — Potential Health HazardTerminated