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 21881–21900 of 38,428 recalls

February 5, 2018· ICU Medical, Inc.

Recalled Item: 6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear

The Issue: The infusion sets were manufactured with an incorrect

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

Class II — Potential Health HazardTerminated
February 5, 2018· ICU Medical, Inc.

Recalled Item: 14 cm (5.5") Appx 0.27 ml

The Issue: The infusion sets were manufactured with an incorrect

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

Class II — Potential Health HazardTerminated
February 5, 2018· ICU Medical, Inc.

Recalled Item: 5" (13 cm) Smallbore Ext Set w/MicroClave¿

The Issue: The infusion sets were manufactured with an incorrect

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

Class II — Potential Health HazardTerminated
February 5, 2018· ICU Medical, Inc.

Recalled Item: 7" Ext Set w/MicroClave¿

The Issue: The infusion sets were manufactured with an incorrect

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

Class II — Potential Health HazardTerminated
February 5, 2018· ICU Medical, Inc.

Recalled Item: 6.5" (17 cm) Appx. 0.57 ml

The Issue: The infusion sets were manufactured with an incorrect

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

Class II — Potential Health HazardTerminated
February 5, 2018· ICU Medical, Inc.

Recalled Item: 7" Smallbore Ext Set w/MicroClave¿

The Issue: The infusion sets were manufactured with an incorrect

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

Class II — Potential Health HazardTerminated
February 2, 2018· Philips Consumer Lifestyle

Recalled Item: Philips Avent Smart Ear Thermometer (SCH740)

The Issue: Device may provide inaccurate measurements

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

Class II — Potential Health HazardTerminated
February 2, 2018· Shippert Medical Technologies

Recalled Item: Tissu-Trans Syringe Fill 360

The Issue: The pouch integrity of the sterile product can't

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

Class II — Potential Health HazardCompleted
February 2, 2018· Shippert Medical Technologies

Recalled Item: Tissu-Trans FILTRON 2000 Recalled by Shippert Medical Technologies Due to

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

Class II — Potential Health HazardCompleted
February 2, 2018· Shippert Medical Technologies

Recalled Item: Tissu-Trans FILTRON 100

The Issue: The pouch integrity of the sterile product can't

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

Class II — Potential Health HazardCompleted
February 2, 2018· Shippert Medical Technologies

Recalled Item: Tissu-Trans FILTRON 500

The Issue: The pouch integrity of the sterile product can't

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

Class II — Potential Health HazardCompleted
February 2, 2018· Shippert Medical Technologies

Recalled Item: Tissu-Trans FILTRON 1000 Recalled by Shippert Medical Technologies Due to

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

Class II — Potential Health HazardCompleted
February 2, 2018· Shippert Medical Technologies

Recalled Item: Tissu-Trans MEGA 1500

The Issue: The pouch integrity of the sterile product can't

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

Class II — Potential Health HazardCompleted
February 2, 2018· Shippert Medical Technologies

Recalled Item: Tissu-Trans FILTRON 250

The Issue: The pouch integrity of the sterile product can't

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

Class II — Potential Health HazardCompleted
February 2, 2018· Merit Medical Systems, Inc.

Recalled Item: 1mL Medallion Syringes Are used to inject fluids into

The Issue: Supplier manufacturing defect with the syringe plunger tip

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

Class II — Potential Health HazardTerminated
February 2, 2018· Dako North America Inc.

Recalled Item: PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to

The Issue: To correct the kit's instructions for use as

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

Class II — Potential Health HazardTerminated
February 2, 2018· Signature Orthopedics Pty Limited

Recalled Item: Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
February 2, 2018· 3M Company - Health Care Business

Recalled Item: 3M Surgical Clipper Professional 9681

The Issue: Failure to follow proper charging practices can result

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

Class II — Potential Health HazardTerminated
February 1, 2018· Medline Industries Inc

Recalled Item: Medline 0.9 % Sodium Chloride Injection

The Issue: Packaged with an incorrect overwrap

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

Class II — Potential Health HazardTerminated
February 1, 2018· Natus Neurology Inc

Recalled Item: Nicolet¿ Ambulatory EEG

The Issue: to be able to import an ambulatory

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

Class II — Potential Health HazardTerminated