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 21621–21640 of 38,428 recalls

March 5, 2018· Tosoh Bioscience Inc

Recalled Item: ST-AIA PACK IGE II

The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays

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

Class II — Potential Health HazardTerminated
March 5, 2018· Tosoh Bioscience Inc

Recalled Item: ST-AIA PACK PA

The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays

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

Class II — Potential Health HazardTerminated
March 5, 2018· Tosoh Bioscience Inc

Recalled Item: ST-AIA PACK T4

The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays

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

Class II — Potential Health HazardTerminated
March 5, 2018· Tosoh Bioscience Inc

Recalled Item: ST-AIA PACK CEA

The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays

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

Class II — Potential Health HazardTerminated
March 5, 2018· Tosoh Bioscience Inc

Recalled Item: ST-AIA PACK Prog II

The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays

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

Class II — Potential Health HazardTerminated
March 5, 2018· Tosoh Bioscience Inc

Recalled Item: ST-AIA PACK CK-MB

The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays

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

Class II — Potential Health HazardTerminated
March 5, 2018· Tosoh Bioscience Inc

Recalled Item: ST-AIA PACK 27.29

The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays

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

Class II — Potential Health HazardTerminated
March 5, 2018· Tosoh Bioscience Inc

Recalled Item: ST-AIA PACK LH II

The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays

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

Class II — Potential Health HazardTerminated
March 5, 2018· Tosoh Bioscience Inc

Recalled Item: ST-AIA DHEA-S

The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays

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

Class II — Potential Health HazardTerminated
March 5, 2018· Tosoh Bioscience Inc

Recalled Item: ST-AIA PACK FT4

The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays

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

Class II — Potential Health HazardTerminated
March 5, 2018· Tosoh Bioscience Inc

Recalled Item: ST-AIA PACK Cystatin C

The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays

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

Class II — Potential Health HazardTerminated
March 5, 2018· Tosoh Bioscience Inc

Recalled Item: ST-AIA PACK TU

The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays

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

Class II — Potential Health HazardTerminated
March 5, 2018· Tosoh Bioscience Inc

Recalled Item: ST-AIA PACK HGH

The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays

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

Class II — Potential Health HazardTerminated
March 5, 2018· Tosoh Bioscience Inc

Recalled Item: ST-AIA PACK AFP

The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays

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

Class II — Potential Health HazardTerminated
March 5, 2018· Tosoh Bioscience Inc

Recalled Item: ST-AIA PACK C-Peptide

The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays

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

Class II — Potential Health HazardTerminated
March 5, 2018· Tosoh Bioscience Inc

Recalled Item: ST-AIA PACK hsE2

The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays

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

Class II — Potential Health HazardTerminated
March 5, 2018· Tosoh Bioscience Inc

Recalled Item: ST-AIA PACK FT3

The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays

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

Class II — Potential Health HazardTerminated
March 5, 2018· Tosoh Bioscience Inc

Recalled Item: ST-AIA PACK TT3

The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays

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

Class II — Potential Health HazardTerminated
March 5, 2018· Tosoh Bioscience Inc

Recalled Item: ST-AIA PACK PAP

The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays

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

Class II — Potential Health HazardTerminated
March 5, 2018· Tosoh Bioscience Inc

Recalled Item: ST-AIA PACK cTnI 2nd Gen

The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays

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

Class II — Potential Health HazardTerminated