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 32401–32420 of 38,428 recalls

August 25, 2014· Navilyst Medical, Inc

Recalled Item: PICC Convenience Kit with Accessories

The Issue: NMI was notified by the manufacturer of the

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

Class II — Potential Health HazardTerminated
August 25, 2014· Navilyst Medical, Inc

Recalled Item: BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit

The Issue: NMI was notified by the manufacturer of the

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

Class II — Potential Health HazardTerminated
August 25, 2014· Navilyst Medical, Inc

Recalled Item: PICC Convenience Kit with Accessories

The Issue: NMI was notified by the manufacturer of the

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

Class II — Potential Health HazardTerminated
August 25, 2014· Navilyst Medical, Inc

Recalled Item: PICC Convenience Kit with Accessories

The Issue: NMI was notified by the manufacturer of the

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

Class II — Potential Health HazardTerminated
August 25, 2014· Navilyst Medical, Inc

Recalled Item: PICC Convenience Kit with Accessories

The Issue: NMI was notified by the manufacturer of the

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

Class II — Potential Health HazardTerminated
August 25, 2014· Navilyst Medical, Inc

Recalled Item: BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit

The Issue: NMI was notified by the manufacturer of the

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

Class II — Potential Health HazardTerminated
August 25, 2014· Beckman Coulter Inc.

Recalled Item: Coulter DxH Diluent

The Issue: Beckman Coulter is recalling Coulter DxH Diluent because

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

Class II — Potential Health HazardTerminated
August 22, 2014· DeRoyal Industries Inc

Recalled Item: DeRoyal(R) SafeLiner Suction Canister Kit

The Issue: These lots of suction canisters and lids have

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

Class II — Potential Health HazardTerminated
August 22, 2014· DeRoyal Industries Inc

Recalled Item: Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER

The Issue: These lots of suction canisters and lids have

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

Class II — Potential Health HazardTerminated
August 21, 2014· Philips Medical Systems, Inc.

Recalled Item: Ingenia

The Issue: When a fused series of a sagittal, coronal

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

Class II — Potential Health HazardTerminated
August 21, 2014· Maquet Medical Systems USA

Recalled Item: TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet

The Issue: The wrong movement results on the MAGNUS OR

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

Class II — Potential Health HazardTerminated
August 21, 2014· Beckman Coulter Inc.

Recalled Item: UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices

The Issue: Beckman Coulter is recalling the Sample Probe Cable

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

Class II — Potential Health HazardTerminated
August 20, 2014· Terumo Cardiovascular Systems Corporation

Recalled Item: Hercules 360 Universal Stabilizing Arm

The Issue: Terumo Cardiovascular Systems (Terumo CVS) is recalling certain

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

Class II — Potential Health HazardTerminated
August 20, 2014· Ortho-Clinical Diagnostics

Recalled Item: VITROS Chemistry Products PHYT (Phenytoin) Slides

The Issue: Ortho Clinical Diagnostics identified a potential for biased

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

Class II — Potential Health HazardTerminated
August 19, 2014· Philips Medical Systems, Inc.

Recalled Item: Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost

The Issue: The hook does not securely hold the footplate

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

Class II — Potential Health HazardTerminated
August 19, 2014· Philips Medical Systems, Inc.

Recalled Item: Patient Support Material Number: 9890 010 87431

The Issue: The hook does not securely hold the footplate

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

Class II — Potential Health HazardTerminated
August 19, 2014· Siemens Healthcare Diagnostics

Recalled Item: ADVIA Centaur XP Immunoassay System (including units)

The Issue: The firm has identified an issue with patient

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

Class II — Potential Health HazardTerminated
August 19, 2014· Siemens Healthcare Diagnostics

Recalled Item: ADVIA Centaur Immunoassay System (including units)

The Issue: The firm has identified an issue with patient

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

Class II — Potential Health HazardTerminated
August 19, 2014· ICU Medical, Inc.

Recalled Item: STAT 2 Flow Controller

The Issue: ICU is recalling the ConMed Stat 2 flow

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

Class I — Serious Health HazardTerminated
August 19, 2014· ICU Medical, Inc.

Recalled Item: 83" (211 cm) Appx 10.3 mL

The Issue: ICU is recalling the ConMed Stat 2 flow

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

Class I — Serious Health HazardTerminated