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 20501–20520 of 38,428 recalls

July 6, 2018· Smiths Medical ASD Inc.

Recalled Item: smiths medical portex First Breath Nasal Oxygen Cannula

The Issue: "Manufactured" and "Use By" labels are transposed incorrectly

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

Class III — Low RiskTerminated
July 6, 2018· Smiths Medical ASD Inc.

Recalled Item: smiths medical portex First Breath Adult Nasal Cannula

The Issue: "Manufactured" and "Use By" labels are transposed incorrectly

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

Class III — Low RiskTerminated
July 6, 2018· Smiths Medical ASD Inc.

Recalled Item: smiths medical portex First Breath Nasal Oxygen Cannula

The Issue: "Manufactured" and "Use By" labels are transposed incorrectly

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

Class III — Low RiskTerminated
July 5, 2018· CTL Medical Corporation

Recalled Item: CTL Medical Hex Driver

The Issue: the anti-toggle ring of the hex driver may

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

Class II — Potential Health HazardTerminated
July 5, 2018· CTL Medical Corporation

Recalled Item: CTL Medical Hex Driver MIS

The Issue: the anti-toggle ring of the hex driver may

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

Class II — Potential Health HazardTerminated
July 5, 2018· Pro-Med Instruments Gmbh

Recalled Item: DORO LUCENT Transitional Member

The Issue: The combination of two different design revisions of

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

Class I — Serious Health HazardTerminated
July 5, 2018· Pro-Med Instruments Gmbh

Recalled Item: DORO LUCENT Base Unit

The Issue: The combination of two different design revisions of

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

Class I — Serious Health HazardTerminated
July 5, 2018· Pro-Med Instruments Gmbh

Recalled Item: DORO LUCENT Locking Transitional Member

The Issue: The combination of two different design revisions of

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

Class I — Serious Health HazardTerminated
July 4, 2018· Medtronic Inc.

Recalled Item: Guardian Connect App CSS7200 used on the iPhone

The Issue: The application may be closed by the operating

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

Class II — Potential Health HazardTerminated
July 3, 2018· Philips Medical Systems (Cleveland) Inc

Recalled Item: Brilliance 16 Air

The Issue: Philips has identified that the compensator within the

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

Class II — Potential Health HazardTerminated
July 3, 2018· Philips Medical Systems (Cleveland) Inc

Recalled Item: Brilliance iCT

The Issue: Philips has identified that the compensator within the

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

Class II — Potential Health HazardTerminated
July 3, 2018· Philips Medical Systems (Cleveland) Inc

Recalled Item: Brilliance 64

The Issue: Philips has identified that the compensator within the

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

Class II — Potential Health HazardTerminated
July 3, 2018· Abbott Vascular

Recalled Item: PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended

The Issue: Incorrect expiration being entered for one lot

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

Class II — Potential Health HazardTerminated
July 3, 2018· Radiometer America Inc

Recalled Item: ABL800 analyzer

The Issue: The analyzer software may cause a mis-match of

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

Class II — Potential Health HazardTerminated
July 3, 2018· Alden Optical

Recalled Item: Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a

The Issue: Vials labeled for the prescriptions contained incorrect lenses

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

Class III — Low RiskTerminated
July 3, 2018· Alden Optical

Recalled Item: Zen RC Toric-Gas permeable contact lenses for Daily Wear in

The Issue: Vials labeled for the prescriptions contained incorrect lenses

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

Class III — Low RiskTerminated
July 3, 2018· Arrow International Inc

Recalled Item: Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip...

The Issue: One lot of product is from product code

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

Class II — Potential Health HazardTerminated
July 3, 2018· ConvaTec, Inc

Recalled Item: AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device

The Issue: Bubble Leak Testing on AbViser AutoValve IAP Monitoring

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

Class II — Potential Health HazardTerminated
July 2, 2018· Radiometer America Inc

Recalled Item: Product: ABL800 FLEX with Crea. The ABL800 with Crea is

The Issue: From three incidents in Denmark and Sweden, comparison

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

Class II — Potential Health HazardTerminated
July 2, 2018· Cypress Medical Products LLC

Recalled Item: Powder Free Vinyl Exam Gloves

The Issue: The firm is recalling one lot of McKesson

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

Class II — Potential Health HazardTerminated