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 17281–17300 of 38,428 recalls

July 10, 2019· B. Braun Medical, Inc.

Recalled Item: CE17TKFCN EPID TRAY W/ 17GA TUOHY NRFIT Catalog # 339186

The Issue: The filter capacity is not achieved due to

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

Class II — Potential Health HazardTerminated
July 10, 2019· B. Braun Medical, Inc.

Recalled Item: ES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT Catalog # 339114

The Issue: The filter capacity is not achieved due to

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

Class II — Potential Health HazardTerminated
July 10, 2019· B. Braun Medical, Inc.

Recalled Item: CE17TKFCSN CON EPI TRAY W/17G TUHY NRFIT Catalog # 339187

The Issue: The filter capacity is not achieved due to

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

Class II — Potential Health HazardTerminated
July 10, 2019· B. Braun Medical, Inc.

Recalled Item: CE18TKSTN CONT EPID W/SOFT TIP NRFIT Catalog # 339191

The Issue: The filter capacity is not achieved due to

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

Class II — Potential Health HazardTerminated
July 10, 2019· B. Braun Medical, Inc.

Recalled Item: CE18TKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339188

The Issue: The filter capacity is not achieved due to

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

Class II — Potential Health HazardTerminated
July 10, 2019· B. Braun Medical, Inc.

Recalled Item: CE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183

The Issue: The filter capacity is not achieved due to

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

Class II — Potential Health HazardTerminated
July 10, 2019· B. Braun Medical, Inc.

Recalled Item: CE18HKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339189

The Issue: The filter capacity is not achieved due to

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

Class II — Potential Health HazardTerminated
July 10, 2019· B. Braun Medical, Inc.

Recalled Item: FEF 100N FLAT EPIDURAL FILTER NRFIT Catalog # 339160

The Issue: The filter capacity is not achieved due to

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

Class II — Potential Health HazardTerminated
July 10, 2019· B. Braun Medical, Inc.

Recalled Item: ES1827KN SPINAL/EPIDURAL TRAY NRFIT Catalog # 339115

The Issue: The filter capacity is not achieved due to

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

Class II — Potential Health HazardTerminated
July 10, 2019· Siemens Healthcare Diagnostics, Inc.

Recalled Item: IMMULITE 1000 Progesterone

The Issue: There is a potential for low discordant progesterone

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

Class II — Potential Health HazardTerminated
July 10, 2019· Radiometer America Inc

Recalled Item: ABL90 FLEX Analyzer UDI:05700693930909

The Issue: Software Security; The action is being initiated because

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

Class II — Potential Health HazardTerminated
July 10, 2019· Siemens Healthcare Diagnostics, Inc.

Recalled Item: IMMULITE 2000 Progesterone

The Issue: There is a potential for low discordant progesterone

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

Class II — Potential Health HazardTerminated
July 10, 2019· Siemens Medical Solutions USA, Inc

Recalled Item: Lantis Commander

The Issue: Potentially affected by the Microsoft Windows Remote Desktop

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

Class II — Potential Health HazardTerminated
July 10, 2019· Gk Photonics Inc

Recalled Item: Burstberry Laser Projection Series

The Issue: The User Remote Interlock Dongle provided with the

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

Class II — Potential Health HazardOngoing
July 10, 2019· Siemens Medical Solutions USA, Inc

Recalled Item: Lantis 8.3 Commander

The Issue: Potentially affected by the Microsoft Windows Remote Desktop

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

Class II — Potential Health HazardTerminated
July 10, 2019· Gk Photonics Inc

Recalled Item: Maxim Laser Projection Series

The Issue: The User Remote Interlock Dongle provided with the

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

Class II — Potential Health HazardOngoing
July 10, 2019· Gk Photonics Inc

Recalled Item: Spectrum Laser Projection Series

The Issue: The User Remote Interlock Dongle provided with the

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

Class II — Potential Health HazardOngoing
July 10, 2019· Siemens Medical Solutions USA, Inc

Recalled Item: Lantis 6.1 Commander

The Issue: Potentially affected by the Microsoft Windows Remote Desktop

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

Class II — Potential Health HazardTerminated
July 10, 2019· Gk Photonics Inc

Recalled Item: Atom Laser Projection Series

The Issue: The User Remote Interlock Dongle provided with the

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

Class II — Potential Health HazardOngoing
July 10, 2019· Siemens Medical Solutions USA, Inc

Recalled Item: Lantis system (pre-2003)

The Issue: Potentially affected by the Microsoft Windows Remote Desktop

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

Class II — Potential Health HazardTerminated