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 19501–19520 of 38,428 recalls
Recalled Item: The Spirit Plus Bed
The Issue: The beds with the high rail side rail
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134
The Issue: Some eluates become colored because of remaining hemoglobin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Spirit Select Bed
The Issue: The beds with the high rail side rail
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Giraffe Omnibed - Product Usage: The OmniBed is a combination
The Issue: GE Healthcare has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1
The Issue: for leakage due to defect in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit
The Issue: for leakage due to defect in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1
The Issue: for leakage due to defect in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hemoglobin A1c Control
The Issue: Tosoh Bioscience has become aware of potential degradation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard
The Issue: The ventilator Inspiratory Safety Guard (ISG) may disconnect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AIA-900 Automated Immunoassay Analyzer
The Issue: Tosoh Bioscience has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product
The Issue: The firm is issuing this voluntary removal following
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AIA-900 Analyzer
The Issue: Tosoh Bioscience has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVO Excel
The Issue: The Evo Excel External-ECG Power-Connection current limit is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic MiniMed 630G 6025805-003_C
The Issue: Reports of occurrences in which insulin pumps with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA Architect system Product Usage: The Signa Architect system is
The Issue: A small area on the bore surface, which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AF w/AS 550 x 1-14ML/HR CPNB
The Issue: cracks on the body of the fill
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AF w/AS 550 x 1-14 ml/hr
The Issue: cracks on the body of the fill
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AF 550 x 5ML/H 6" CATH
The Issue: cracks on the body of the fill
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AF 550 x 5ML/H 6" DUAL CATHS
The Issue: cracks on the body of the fill
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AF w/AS 550 x 1-14ML/HR 2ML-30LO CPNB
The Issue: cracks on the body of the fill
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.