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 27881–27900 of 38,428 recalls

February 16, 2016· Baxter Healthcare Corp.

Recalled Item: Automated peritoneal dialysis (APD) cycler

The Issue: Baxter Healthcare Corporation is sending this communication to

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

Class II — Potential Health HazardTerminated
February 16, 2016· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The

The Issue: Siemens Healthcare Diagnostics has determined that Dimension Vista

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

Class II — Potential Health HazardTerminated
February 16, 2016· Ortho-Clinical Diagnostics

Recalled Item: VITROS 5600 Integrated System

The Issue: The two sets of wires (4 total wires)

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

Class II — Potential Health HazardTerminated
February 16, 2016· Richard-Allan Scientific Company

Recalled Item: Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use.

The Issue: Multiple complaints were received from customers indicating that

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

Class III — Low RiskTerminated
February 16, 2016· Siemens Medical Solutions USA, Inc

Recalled Item: CIOS ALPHA (Image-intensified fluoroscope x-ray system) Product Usage: The Cios

The Issue: Siemens found a defective part in their production

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

Class II — Potential Health HazardTerminated
February 16, 2016· Synthes (USA) Products LLC

Recalled Item: Synthes Interlocking Bolt

The Issue: DePuy Synthes is initiating a voluntary medical device

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

Class II — Potential Health HazardTerminated
February 16, 2016· Intuitive Surgical, Inc.

Recalled Item: da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console...

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

Class II — Potential Health HazardTerminated
February 16, 2016· CooperSurgical, Inc.

Recalled Item: Milex Arcing Diaphragm Size 95

The Issue: The products have been identified to contain an

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

Class II — Potential Health HazardTerminated
February 16, 2016· Biomet, Inc.

Recalled Item: Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong...

The Issue: Zimmer Biomet Inc. Verso Shoulder Forked Retractor (Comprehensive

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

Class II — Potential Health HazardTerminated
February 16, 2016· Biomet, Inc.

Recalled Item: HipLOC CHS Plate/Lag Screw Introducer

The Issue: A complaint was received where the Hiploc Plate/Lag

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

Class II — Potential Health HazardTerminated
February 15, 2016· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT

The Issue: Siemens is initiating this recall due to a

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

Class II — Potential Health HazardTerminated
February 15, 2016· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT

The Issue: Siemens is initiating this recall due to a

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

Class II — Potential Health HazardTerminated
February 15, 2016· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT

The Issue: Siemens is initiating this recall due to a

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

Class II — Potential Health HazardTerminated
February 15, 2016· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT

The Issue: Siemens is initiating this recall due to a

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

Class II — Potential Health HazardTerminated
February 15, 2016· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT

The Issue: Siemens is initiating this recall due to a

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

Class II — Potential Health HazardTerminated
February 15, 2016· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT

The Issue: Siemens is initiating this recall due to a

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

Class II — Potential Health HazardTerminated
February 15, 2016· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT

The Issue: Siemens is initiating this recall due to a

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

Class II — Potential Health HazardTerminated
February 15, 2016· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT

The Issue: Siemens is initiating this recall due to a

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

Class II — Potential Health HazardTerminated
February 15, 2016· CareFusion 303, Inc.

Recalled Item: Alaris Pump VersaSafe Infusion Set

The Issue: CareFusion is recalling the Alaris VersaSafe Infusion Set

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

Class II — Potential Health HazardTerminated
February 14, 2016· Euro Diagnostica AB

Recalled Item: Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA)

The Issue: Decreasing performance overtime

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

Class II — Potential Health HazardTerminated