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 17601–17620 of 38,428 recalls

June 6, 2019· DRG Instruments GmbH

Recalled Item: DRG Salivary Progesterone HS ELISA- IVD for the determination of

The Issue: Salivary Progesterone assay may observe a higher percentage

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

Class II — Potential Health HazardTerminated
June 6, 2019· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number:

The Issue: Artis Zee, Artis Q, Artis Pheno or Artis

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

Class II — Potential Health HazardTerminated
June 6, 2019· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens Artis Q zeego ---Interventional Fluoroscopic X-Ray System Model Number:

The Issue: Artis Zee, Artis Q, Artis Pheno or Artis

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

Class II — Potential Health HazardTerminated
June 6, 2019· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens Artis Q floor --Interventional Fluoroscopic X-Ray System Model Number:

The Issue: Artis Zee, Artis Q, Artis Pheno or Artis

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

Class II — Potential Health HazardTerminated
June 6, 2019· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens Artis Q ceiling--Interventional Fluoroscopic X-Ray System Model...

The Issue: Artis Zee, Artis Q, Artis Pheno or Artis

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

Class II — Potential Health HazardTerminated
June 6, 2019· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens Artis zee biplane-Interventional Fluoroscopic X-Ray System Model...

The Issue: Artis Zee, Artis Q, Artis Pheno or Artis

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

Class II — Potential Health HazardTerminated
June 6, 2019· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens Artis zee ceiling -Interventional Fluoroscopic X-Ray System Model...

The Issue: Artis Zee, Artis Q, Artis Pheno or Artis

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

Class II — Potential Health HazardTerminated
June 6, 2019· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System Model...

The Issue: Artis Zee, Artis Q, Artis Pheno or Artis

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

Class II — Potential Health HazardTerminated
June 6, 2019· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model...

The Issue: Artis Zee, Artis Q, Artis Pheno or Artis

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

Class II — Potential Health HazardTerminated
June 6, 2019· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens Artis Q.zen floor----Interventional Fluoroscopic X-Ray System Model...

The Issue: Artis Zee, Artis Q, Artis Pheno or Artis

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

Class II — Potential Health HazardTerminated
June 6, 2019· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens Artis pheno-Interventional Fluoroscopic X-Ray System Model Number:...

The Issue: Artis Zee, Artis Q, Artis Pheno or Artis

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

Class II — Potential Health HazardTerminated
June 6, 2019· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model...

The Issue: Artis Zee, Artis Q, Artis Pheno or Artis

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

Class II — Potential Health HazardTerminated
June 6, 2019· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number:...

The Issue: Artis Zee, Artis Q, Artis Pheno or Artis

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

Class II — Potential Health HazardTerminated
June 5, 2019· Qiagen Sciences LLC

Recalled Item: Filter-Tips

The Issue: Kit lots contain a small percentage of damaged

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

Class I — Serious Health HazardTerminated
June 5, 2019· GETINGE US SALES LLC

Recalled Item: PulsioFlex Monitoring System

The Issue: The monitor displays an error message . The

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

Class II — Potential Health HazardTerminated
June 4, 2019· Inlightened Partners LLC

Recalled Item: inLight Medical LED Pads used with Polychromatic light technology system

The Issue: LED pads with cord connectors that have v-shaped

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

Class III — Low RiskTerminated
June 4, 2019· Zimmer Biomet, Inc.

Recalled Item: Ultra-Drive Irrigation Tubing Assembly

The Issue: The products do not have sufficient data to

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

Class II — Potential Health HazardTerminated
June 4, 2019· Zimmer Biomet, Inc.

Recalled Item: Ultra-Drive Hose/Drape Assembly

The Issue: The products do not have sufficient data to

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

Class II — Potential Health HazardTerminated
June 4, 2019· Siemens Medical Solutions USA, Inc

Recalled Item: SOMATOM go.Now

The Issue: The potential sporadic performance problems may cause scanning

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

Class II — Potential Health HazardTerminated
June 4, 2019· Siemens Medical Solutions USA, Inc

Recalled Item: SOMATOM go.Top

The Issue: The potential sporadic performance problems may cause scanning

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

Class II — Potential Health HazardTerminated