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 2241–2260 of 38,428 recalls
Recalled Item: ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.
The Issue: transit delays of certain cold chain products due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.
The Issue: transit delays of certain cold chain products due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.
The Issue: transit delays of certain cold chain products due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.
The Issue: transit delays of certain cold chain products due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.
The Issue: transit delays of certain cold chain products due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABBOTT RAPID DX N AMERICA LLC
The Issue: transit delays of certain cold chain products due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.
The Issue: transit delays of certain cold chain products due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT.
The Issue: transit delays of certain cold chain products due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.
The Issue: transit delays of certain cold chain products due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA.
The Issue: transit delays of certain cold chain products due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.
The Issue: transit delays of certain cold chain products due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.
The Issue: transit delays of certain cold chain products due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT.
The Issue: transit delays of certain cold chain products due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.
The Issue: transit delays of certain cold chain products due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR.
The Issue: transit delays of certain cold chain products due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.
The Issue: transit delays of certain cold chain products due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT.
The Issue: transit delays of certain cold chain products due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT.
The Issue: transit delays of certain cold chain products due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR.
The Issue: transit delays of certain cold chain products due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE
The Issue: transit delays of certain cold chain products due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.