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 26221–26240 of 38,428 recalls
Recalled Item: Monitoring Kit w/TP4
The Issue: ICU Medical Inc. has identified a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HEART KIT W/03ML FLUSH DEVICE FOR ST. JOSEPHS HOSP.
The Issue: ICU Medical Inc. has identified a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Expression MR IBP DPT Kit
The Issue: ICU Medical Inc. has identified a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cath Lab Kit w/03 ml Squeeze Flush
The Issue: ICU Medical Inc. has identified a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Transpac¿ IV Monitoring Kit
The Issue: ICU Medical Inc. has identified a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KIT W/30ML FLUSH DEVICE FOR ALL CHILDRENS Hospital
The Issue: ICU Medical Inc. has identified a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRANSDUCER KIT W/30ML FLUSH DEVICE FOR CHILDRENS HOSP. OF WISC.
The Issue: ICU Medical Inc. has identified a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OPEN HEART MONITORING KIT WITH 03ML FLUSH DEVICE FOR ORLANDO REG. MED. CTR.
The Issue: ICU Medical Inc. has identified a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SAFESET" KIT W/03ML FLUSH DEVICE FOR HOLMES REG. M.C.
The Issue: ICU Medical Inc. has identified a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roche COBAS INTEGRA c111 Analyzer
The Issue: cobas c 111 analyzers (catalog numbers 04777433001 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The surgical table is a stand alone unit. Three (3)
The Issue: The floor locking cylinders contained in the base
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies
The Issue: There is the potential for contaminated water to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended
The Issue: Oxygen tubing and the oxygen connector of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Urea Base Agar
The Issue: Storage temperature listed on the label was incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch"
The Issue: The cleaning instructions provided in FemTouch Operator's Manual
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioSentry Tract Sealant System
The Issue: Surgical Specialties Mexico is recalling the BioSentry Track
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G
The Issue: Merit Medical Systems, Inc. announces a voluntary field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Manifold Kit. Catalog Number K09-11867AP
The Issue: Merit Medical Systems, Inc. announces a voluntary field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
The Issue: Merit Medical Systems, Inc. announces a voluntary field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Waste Management Kit. Catalog Number K10-04381AP
The Issue: Merit Medical Systems, Inc. announces a voluntary field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.