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 37741–37760 of 38,428 recalls

May 9, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 12-GAUGE BLUE

The Issue: During production of the Sarns Antegrade Cardioplegia Cannula,

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

Class II — Potential Health HazardTerminated
May 9, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: INDIANA/OHIO HEART Product Usage: The Sarns Cardioplegia Cannula and...

The Issue: During production of the Sarns Antegrade Cardioplegia Cannula,

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

Class II — Potential Health HazardTerminated
May 9, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: CPB CATHETER KIT-DR VANTRIGHT Product Usage: The Sarns Cardioplegia Cannula

The Issue: During production of the Sarns Antegrade Cardioplegia Cannula,

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

Class II — Potential Health HazardTerminated
May 9, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 14-GAUGE WHITE

The Issue: During production of the Sarns Antegrade Cardioplegia Cannula,

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

Class II — Potential Health HazardTerminated
May 9, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: X-COATED H/L PK W/FX15RW40 Product Usage: The Sarns Cardioplegia Cannula

The Issue: During production of the Sarns Antegrade Cardioplegia Cannula,

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

Class II — Potential Health HazardTerminated
May 9, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: CPB CATHETER KIT- DR HENDRICKSO Product Usage: The Sarns Cardioplegia

The Issue: During production of the Sarns Antegrade Cardioplegia Cannula,

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

Class II — Potential Health HazardTerminated
May 9, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia Cannula

The Issue: During production of the Sarns Antegrade Cardioplegia Cannula,

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

Class II — Potential Health HazardTerminated
May 9, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: X-COATED FX25RW H/L PACK Product Usage: The Sarns Cardioplegia Cannula

The Issue: During production of the Sarns Antegrade Cardioplegia Cannula,

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

Class II — Potential Health HazardTerminated
May 9, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: CPB CATHETER KIT- DR OWEN Product Usage: The Sarns Cardioplegia

The Issue: During production of the Sarns Antegrade Cardioplegia Cannula,

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

Class II — Potential Health HazardTerminated
May 9, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia Cannula

The Issue: During production of the Sarns Antegrade Cardioplegia Cannula,

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

Class II — Potential Health HazardTerminated
May 9, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: XC HEART/LUNG PACK W/SX25RX Product Usage: The Sarns Cardioplegia Cannula

The Issue: During production of the Sarns Antegrade Cardioplegia Cannula,

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

Class II — Potential Health HazardTerminated
May 9, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: CUSTOM CPB CATHETER KIT-DR. Product Usage: The Sarns Cardioplegia Cannula

The Issue: During production of the Sarns Antegrade Cardioplegia Cannula,

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

Class II — Potential Health HazardTerminated
May 9, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: CPB CATHETER KIT-DR VANTRIGHT Product Usage: The Sarns Cardioplegia Cannula

The Issue: During production of the Sarns Antegrade Cardioplegia Cannula,

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

Class II — Potential Health HazardTerminated
May 9, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: CPB CATHETER KIT-DR GERHARDT Product Usage: The Sarns Cardioplegia Cannula

The Issue: During production of the Sarns Antegrade Cardioplegia Cannula,

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

Class II — Potential Health HazardTerminated
May 9, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: MAYO MN XCOATED 3/8X1/2 AV Product Usage: The Sarns Cardioplegia

The Issue: During production of the Sarns Antegrade Cardioplegia Cannula,

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

Class II — Potential Health HazardTerminated
May 9, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: SARNS ANTEGRADE: CARDIOPLEGIA CANNULA: ROOT INFUSION VENT/CATHETER WITH 14-...

The Issue: During production of the Sarns Antegrade Cardioplegia Cannula,

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

Class II — Potential Health HazardTerminated
May 9, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: CPB CATHETER KIT-DR BARTLES Product Usage: The Sarns Cardioplegia Cannula

The Issue: During production of the Sarns Antegrade Cardioplegia Cannula,

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

Class II — Potential Health HazardTerminated
May 9, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: SARNS FLEXIBLE ARTERIAL CANNULA: 7.3 MM (22 FR) 00 WITH 3/8" CONNECTOR

The Issue: During production of one lot of the Sarns

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

Class II — Potential Health HazardTerminated
May 9, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: SARNS HIGH-FLOW AORTIC ARCH CANNULA: 5.2 MM (16 FR) 00 WITH 3/8" CONNECTOR

The Issue: During production of one lot of the Sarns

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

Class II — Potential Health HazardTerminated
May 9, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) WITH 3/8" CONNECTOR

The Issue: During production of one lot of the Sarns

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

Class II — Potential Health HazardTerminated