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 21661–21680 of 38,428 recalls

March 2, 2018· Beckman Coulter Inc.

Recalled Item: BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer

The Issue: Beckman Coulter has determined that there is a

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

Class II — Potential Health HazardTerminated
March 1, 2018· ICU Medical de Mexico, S.A. de C.V.

Recalled Item: 30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold

The Issue: ICU Medical is expanding the scope of their

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

Class II — Potential Health HazardTerminated
March 1, 2018· ICU Medical de Mexico, S.A. de C.V.

Recalled Item: PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold

The Issue: ICU Medical is expanding the scope of their

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

Class II — Potential Health HazardTerminated
March 1, 2018· ICU Medical de Mexico, S.A. de C.V.

Recalled Item: 40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold

The Issue: ICU Medical is expanding the scope of their

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

Class II — Potential Health HazardTerminated
March 1, 2018· ICU Medical de Mexico, S.A. de C.V.

Recalled Item: Kit w/3 Ext Sets

The Issue: ICU Medical is expanding the scope of their

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

Class II — Potential Health HazardTerminated
March 1, 2018· ICU Medical de Mexico, S.A. de C.V.

Recalled Item: 38 cm (15") Smallbore Ext Set w/6-Port NanoClave Manifold

The Issue: ICU Medical is expanding the scope of their

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

Class II — Potential Health HazardTerminated
March 1, 2018· ICU Medical de Mexico, S.A. de C.V.

Recalled Item: PROXIMALE - 18 cm (7") Appx 0.92 ml

The Issue: ICU Medical is expanding the scope of their

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

Class II — Potential Health HazardTerminated
March 1, 2018· ICU Medical de Mexico, S.A. de C.V.

Recalled Item: 191 cm (75") Appx 2.9 ml

The Issue: ICU Medical is expanding the scope of their

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

Class II — Potential Health HazardTerminated
March 1, 2018· ICU Medical de Mexico, S.A. de C.V.

Recalled Item: 20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold

The Issue: ICU Medical is expanding the scope of their

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

Class II — Potential Health HazardTerminated
March 1, 2018· ICU Medical de Mexico, S.A. de C.V.

Recalled Item: 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold

The Issue: ICU Medical is expanding the scope of their

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

Class II — Potential Health HazardTerminated
March 1, 2018· ICU Medical de Mexico, S.A. de C.V.

Recalled Item: 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange

The Issue: ICU Medical is expanding the scope of their

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

Class II — Potential Health HazardTerminated
March 1, 2018· ICU Medical de Mexico, S.A. de C.V.

Recalled Item: 10" Smallbore Ext Set w/6-Port NanoClave Manifold

The Issue: ICU Medical is expanding the scope of their

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

Class II — Potential Health HazardTerminated
March 1, 2018· ICU Medical de Mexico, S.A. de C.V.

Recalled Item: DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold

The Issue: ICU Medical is expanding the scope of their

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

Class II — Potential Health HazardTerminated
March 1, 2018· ICU Medical de Mexico, S.A. de C.V.

Recalled Item: 165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold

The Issue: ICU Medical is expanding the scope of their

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

Class II — Potential Health HazardTerminated
March 1, 2018· ICU Medical de Mexico, S.A. de C.V.

Recalled Item: 216 cm (85") PVC/PUR Smallbore Bifuse Ext Set w/3-Port NanoClave Manifold

The Issue: ICU Medical is expanding the scope of their

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

Class II — Potential Health HazardTerminated
March 1, 2018· ICU Medical de Mexico, S.A. de C.V.

Recalled Item: 61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold

The Issue: ICU Medical is expanding the scope of their

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

Class II — Potential Health HazardTerminated
March 1, 2018· ICU Medical de Mexico, S.A. de C.V.

Recalled Item: 43 cm (17") Smallbore Ext Set w/3-Port NanoClave Manifold

The Issue: ICU Medical is expanding the scope of their

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

Class II — Potential Health HazardTerminated
March 1, 2018· ICU Medical de Mexico, S.A. de C.V.

Recalled Item: 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange

The Issue: ICU Medical is expanding the scope of their

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

Class II — Potential Health HazardTerminated
March 1, 2018· ICU Medical de Mexico, S.A. de C.V.

Recalled Item: 11" Smallbore Ext Set w/NanoClave

The Issue: ICU Medical is expanding the scope of their

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

Class II — Potential Health HazardTerminated
March 1, 2018· ICU Medical de Mexico, S.A. de C.V.

Recalled Item: 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold

The Issue: ICU Medical is expanding the scope of their

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

Class II — Potential Health HazardTerminated