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 18861–18880 of 38,428 recalls

February 11, 2019· Smiths Medical ASD Inc.

Recalled Item: Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device

The Issue: Incorrect needle length and gage

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

Class II — Potential Health HazardTerminated
February 11, 2019· Fenwal Inc

Recalled Item: Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous...

The Issue: The optional Vacuum Unit may stop working and

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

Class II — Potential Health HazardTerminated
February 8, 2019· Riverpoint Medical, LLC

Recalled Item: Riverpoint Medical 18G Brachy Grid

The Issue: The integrity of the sterile grid packaging is

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

Class II — Potential Health HazardTerminated
February 8, 2019· Canon Medical System, USA, INC.

Recalled Item: Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) -...

The Issue: Table tilts without operator involvement as a result

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

Class II — Potential Health HazardTerminated
February 8, 2019· Terumo Medical Corporation

Recalled Item: Terumo Needle

The Issue: There is a potential for a loss of

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

Class II — Potential Health HazardTerminated
February 8, 2019· Terumo Medical Corporation

Recalled Item: Terumo Sur-vet Needle

The Issue: There is a potential for a loss of

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

Class II — Potential Health HazardTerminated
February 8, 2019· Terumo Medical Corporation

Recalled Item: Terumo Sur-vet Needle

The Issue: There is a potential for a loss of

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

Class II — Potential Health HazardTerminated
February 8, 2019· Terumo Medical Corporation

Recalled Item: Terumo Sur-vet Needle

The Issue: There is a potential for a loss of

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

Class II — Potential Health HazardTerminated
February 8, 2019· Terumo Medical Corporation

Recalled Item: Terumo Sur-vet Needle

The Issue: There is a potential for a loss of

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

Class II — Potential Health HazardTerminated
February 8, 2019· Terumo Medical Corporation

Recalled Item: Terumo Needle

The Issue: There is a potential for a loss of

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

Class II — Potential Health HazardTerminated
February 8, 2019· Terumo Medical Corporation

Recalled Item: Terumo Needle

The Issue: There is a potential for a loss of

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

Class II — Potential Health HazardTerminated
February 8, 2019· Terumo Medical Corporation

Recalled Item: Terumo Sur-vet Needle

The Issue: There is a potential for a loss of

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

Class II — Potential Health HazardTerminated
February 8, 2019· Terumo Medical Corporation

Recalled Item: Terumo Sur-vet Needle

The Issue: There is a potential for a loss of

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

Class II — Potential Health HazardTerminated
February 8, 2019· Maquet Cardiovascular Us Sales, Llc

Recalled Item: Cardiohelp Emergency Drive

The Issue: Upon servicing the gearwheel in the Emergency Drive

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

Class I — Serious Health HazardTerminated
February 8, 2019· Draegar Medical Systems, Inc.

Recalled Item: Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta

The Issue: The firm is recalling their Delta family of

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

Class II — Potential Health HazardOngoing
February 8, 2019· Draegar Medical Systems, Inc.

Recalled Item: Omega Systems These devices are intended to be used in

The Issue: The firm is recalling their Delta family of

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

Class II — Potential Health HazardOngoing
February 8, 2019· Siemens Medical Solutions USA, Inc

Recalled Item: Uroskop Omnia Max -fluoroscopic X-ray system Model # 10762473 Uroskop

The Issue: The swivel arm holding the monitors may become

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

Class II — Potential Health HazardTerminated
February 8, 2019· Siemens Medical Solutions USA, Inc

Recalled Item: Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop

The Issue: The swivel arm holding the monitors may become

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

Class II — Potential Health HazardTerminated
February 8, 2019· Elekta, Inc.

Recalled Item: Monaco Radiation Treatment Planning (RTP) System

The Issue: If Improve Target Dose was chosen as an

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

Class II — Potential Health HazardTerminated
February 7, 2019· Cordis Corporation

Recalled Item: Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage:

The Issue: Frayed pieces of the mounting card being inside

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

Class III — Low RiskTerminated