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 18941–18960 of 38,428 recalls

January 17, 2019· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: Medtronic Power Supply 26907

The Issue: There is a potential for an electrical short

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

Class II — Potential Health HazardTerminated
January 17, 2019· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: Medtronic implantable pulse generator: SENSIA

The Issue: A subset of Medtronic dual chamber pacemakers distributed

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

Class I — Serious Health HazardOngoing
January 17, 2019· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: Medtronic implantable pulse generator: Sphera DR MRI SureScan

The Issue: A subset of Medtronic dual chamber pacemakers distributed

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

Class I — Serious Health HazardOngoing
January 17, 2019· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: Medtronic implantable pulse generator: RELIA

The Issue: A subset of Medtronic dual chamber pacemakers distributed

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

Class I — Serious Health HazardOngoing
January 17, 2019· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan

The Issue: A subset of Medtronic dual chamber pacemakers distributed

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

Class I — Serious Health HazardOngoing
January 17, 2019· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: vitatron (implantable pulse generator): (a) A-series

The Issue: A subset of Medtronic dual chamber pacemakers distributed

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

Class I — Serious Health HazardOngoing
January 17, 2019· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: Medtronic implantable pulse generator: Versa

The Issue: A subset of Medtronic dual chamber pacemakers distributed

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

Class I — Serious Health HazardOngoing
January 17, 2019· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: Medtronic implantable pulse generator: ADAPTA

The Issue: A subset of Medtronic dual chamber pacemakers distributed

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

Class I — Serious Health HazardOngoing
January 17, 2019· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: MEDTRONIC CARELINK 2090 programmer

The Issue: There is an error in how the programmer

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

Class II — Potential Health HazardTerminated
January 17, 2019· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices

The Issue: The Medtronic CareLink Encore 29901 programmer system is

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

Class II — Potential Health HazardTerminated
January 16, 2019· Polymer Technology Systems, Inc.

Recalled Item: CHOL+HDL+GLU test strips

The Issue: Some lots of test strips do not fit

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

Class II — Potential Health HazardTerminated
January 16, 2019· Polymer Technology Systems, Inc.

Recalled Item: Lipid Panel test strips (as a component of smart bundles)

The Issue: Some lots of test strips do not fit

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

Class II — Potential Health HazardTerminated
January 16, 2019· Polymer Technology Systems, Inc.

Recalled Item: Lipid Panel test strips

The Issue: Some lots of test strips do not fit

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

Class II — Potential Health HazardTerminated
January 16, 2019· Carolina Liquid Chemistries

Recalled Item: CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT Recalled by Carolina...

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

Class III — Low RiskTerminated
January 16, 2019· Carolina Liquid Chemistries

Recalled Item: CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT

The Issue: Supplier testing showed that the absorbance rate of

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

Class III — Low RiskTerminated
January 16, 2019· Edwards Lifesciences, LLC

Recalled Item: Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a...

The Issue: Edwards Lifesciences has received a limited number of

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

Class II — Potential Health HazardOngoing
January 16, 2019· Intuitive Surgical, Inc.

Recalled Item: daVinci Harmonic ACE Curved Shears

The Issue: During an internal inspection, Intuitive found that the

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

Class II — Potential Health HazardOngoing
January 15, 2019· Westmed, Inc.

Recalled Item: Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask

The Issue: A repair was made to an adapter mold

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

Class II — Potential Health HazardTerminated
January 15, 2019· Westmed, Inc.

Recalled Item: Neo-Vent Infant T-Piece Resuscitation Circuit

The Issue: A repair was made to an adapter mold

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

Class II — Potential Health HazardTerminated
January 15, 2019· Westmed, Inc.

Recalled Item: Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask

The Issue: A repair was made to an adapter mold

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

Class II — Potential Health HazardTerminated