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 14681–14700 of 38,428 recalls

July 6, 2020· ICU Medical, Inc.

Recalled Item: 112 IN (284cm) APPX 14.8ml

The Issue: Identification of a potential manufacturing defect on the

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

Class II — Potential Health HazardTerminated
July 6, 2020· ICU Medical, Inc.

Recalled Item: 54 IN (137 cm) APPX 7.2 ml EXT SET w NanoClave 4-Way Stopcock

The Issue: Identification of a potential manufacturing defect on the

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

Class II — Potential Health HazardTerminated
July 6, 2020· ICU Medical, Inc.

Recalled Item: 5.5" (14 cm) Appx 0.39 ml

The Issue: Identification of a potential manufacturing defect on the

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

Class II — Potential Health HazardTerminated
July 6, 2020· ICU Medical, Inc.

Recalled Item: 11 IN(28cm)APPX 0.97ml

The Issue: Identification of a potential manufacturing defect on the

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

Class II — Potential Health HazardTerminated
July 6, 2020· ICU Medical, Inc.

Recalled Item: 112 IN(284cm) APPX 14.6ml

The Issue: Identification of a potential manufacturing defect on the

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

Class II — Potential Health HazardTerminated
July 6, 2020· ICU Medical, Inc.

Recalled Item: 7" (18 cm) Appx 0.32 ml

The Issue: Identification of a potential manufacturing defect on the

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

Class II — Potential Health HazardTerminated
July 6, 2020· ICU Medical, Inc.

Recalled Item: 10 IN (25cm) APPX 1.5ml EXT w/6-Port NanoClave Manifold

The Issue: Identification of a potential manufacturing defect on the

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

Class II — Potential Health HazardTerminated
July 6, 2020· ICU Medical, Inc.

Recalled Item: 128" (325 cm) Appx 16.6 ml

The Issue: Identification of a potential manufacturing defect on the

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

Class II — Potential Health HazardTerminated
July 6, 2020· Arrow International Inc

Recalled Item: Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural

The Issue: The lidstock states the incorrect expiration date for

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

Class II — Potential Health HazardTerminated
July 6, 2020· Golden Technologies, Inc.

Recalled Item: Golden Technologies Model Number PR515 Lift Chair - Product Usage:

The Issue: Suspect poor weld on back KD bar

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

Class II — Potential Health HazardTerminated
July 6, 2020· Arrow International Inc

Recalled Item: Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The

The Issue: The lidstock states the incorrect expiration date for

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

Class II — Potential Health HazardTerminated
July 6, 2020· Arrow International Inc

Recalled Item: Cannon II Plus Replacement Hub Set - Product Usage: is

The Issue: The lidstock states the incorrect expiration date for

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

Class II — Potential Health HazardTerminated
July 6, 2020· Arrow International Inc

Recalled Item: NextStep Retrograde Replacement Hub Set - Product Usage: is indicated

The Issue: The lidstock states the incorrect expiration date for

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

Class II — Potential Health HazardTerminated
July 6, 2020· Boston Scientific Corporation

Recalled Item: Captivator Polypectomy Snare

The Issue: BSC has noted a potential inability to cut

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

Class II — Potential Health HazardOngoing
July 6, 2020· Boston Scientific Corporation

Recalled Item: Captivator Polypectomy Snare

The Issue: BSC has noted a potential inability to cut

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

Class II — Potential Health HazardOngoing
July 6, 2020· Boston Scientific Corporation

Recalled Item: Captivator Polypectomy Snare

The Issue: BSC has noted a potential inability to cut

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

Class II — Potential Health HazardOngoing
July 6, 2020· Boston Scientific Corporation

Recalled Item: Captivator Polypectomy Snare

The Issue: BSC has noted a potential inability to cut

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

Class II — Potential Health HazardOngoing
July 6, 2020· Boston Scientific Corporation

Recalled Item: Captiflex Snares

The Issue: BSC has noted a potential inability to cut

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

Class II — Potential Health HazardOngoing
July 6, 2020· Boston Scientific Corporation

Recalled Item: Captivator Polypectomy Snare

The Issue: BSC has noted a potential inability to cut

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

Class II — Potential Health HazardOngoing
July 6, 2020· Boston Scientific Corporation

Recalled Item: Captivator Polypectomy Snare

The Issue: BSC has noted a potential inability to cut

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

Class II — Potential Health HazardOngoing