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 23801–23820 of 38,428 recalls
Recalled Item: RED SEXP DSTL FEM 19CM LT ASSY
The Issue: Possibility that the patient label inside the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COMP PRIMARY STEM 8MM MINI
The Issue: Possibility that the patient label inside the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CER BIOLOXD OPTION HD 32MM
The Issue: Possibility that the patient label inside the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lateral Troch Plate Full Crimp - 254mm
The Issue: Possibility that the patient label inside the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ECHO POR FMRL NC 9X125
The Issue: Possibility that the patient label inside the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS N/T Protein Control SL for use on the BN II
The Issue: Siemens Healthcare Diagnostics has confirmed a negative bias
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS N Protein Standard SL
The Issue: Siemens Healthcare Diagnostics has confirmed a negative bias
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non
The Issue: The medication cassette reservoir, part number 21-7002-24, with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional
The Issue: Inadequate seal due to lack of adhesive glue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arctic Sun ArcticGel Pads - Medium
The Issue: Label on product box contains the incorrect reference
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension
The Issue: Customer complaint of a cut in the side
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infinity 7
The Issue: The firm discovered a risk of loss of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infinity 5
The Issue: The firm discovered a risk of loss of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infinity 7
The Issue: The firm discovered a risk of loss of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proclaim 7 Elite
The Issue: The firm discovered a risk of loss of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infinity 5
The Issue: The firm discovered a risk of loss of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proclaim 5 Elite
The Issue: The firm discovered a risk of loss of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BLUE BURN SHEET
The Issue: Intact carton revealed presence of shredded burn sheets
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD PhoenixTM AP
The Issue: unexpected movement of robot arm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable
The Issue: There is a possibility that the finished good
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.