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 2261–2280 of 38,428 recalls
Recalled Item: ABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR.
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 VANCOMYCIN (300/BX)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 RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD
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 FS(3PK/BX)ORCLNL DILUENT PACK 3.
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 MULTI ANALYTE LVL1&2250UL CHOLS 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 TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK)...
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 MAC CONKEY II AGAR (100/CT) 21270 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 ALINITY I ANTI-CCPS REAGENT.
The Issue: transit delays of certain cold chain products due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Novum IQ LVP INFUSION SYSTEM
The Issue: There is a potential for the Novum IQ
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxI 9000 Access Immunoassay Analyzer
The Issue: A new motor/encoder and cable was introduced into
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MIRA SURGICAL SYSTEM
The Issue: The MIRA Surgical System Software Version 4.0.3 loaded
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque...
The Issue: breach of sterile barrier packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack....
The Issue: breach of sterile barrier packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxI 9000 Access Immunoassay Analyzer
The Issue: A new software update (v1.20) is introducing error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque...
The Issue: breach of sterile barrier packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
The Issue: breach of sterile barrier packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque...
The Issue: breach of sterile barrier packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Apo B Reagent
The Issue: The product Value Assignment Sheet (VAS) is used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M Ranger Irrigation Fluid Warming Set
The Issue: Notice was issued to clarify flow rates related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICU Medical Plum Solos
The Issue: Internal testing found that Plum Duo pumps with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.