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.
Showing 21641–21660 of 38,428 recalls
Recalled Item: ST-AIA PACK Estradiol
The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ST-AIA PACK BMG
The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ST-AIA PACK C-Peptide II
The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ST-AIA PACK HCG
The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ST-AIA PACK Myoglobin
The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ST-AIA PACK SHBG
The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AIA-PACK TSH 3rd Generation
The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ST-AIA PACK IRI
The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tosoh ST AIA-PACK HbA1c Control
The Issue: The assay can potentially generate erroneously elevated or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tosoh ST AIA-PACK HbA1c
The Issue: The assay can potentially generate erroneously elevated or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tosoh ST AIA-PACK HbA1c Calibrator
The Issue: The assay can potentially generate erroneously elevated or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tosoh ST AIA-PACK HbA1c Pretreatment Solution
The Issue: The assay can potentially generate erroneously elevated or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON SC2000 Ultrasound System. The firm name on the label
The Issue: The ECG signal may flatline due to electromagnetic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flex Arm Product Usage: The Synthes Flex Arm is a
The Issue: Quick connect feature of instruments may be unable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BECKMAN COULTER iChemVELOCITY
The Issue: Beckman Coulter has determined that there is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lipase
The Issue: Randox has now released further steps to avoid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD MAX DNA MMK (SPC) For Laboratory Use
The Issue: The package insert incorrectly lists the volume of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD MAX DNA MMK Lab Use
The Issue: The package insert incorrectly lists the volume of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Getinge AGS
The Issue: There is potential for a cart with disinfected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Getinge AGS
The Issue: There is potential for a cart with disinfected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.