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 33421–33440 of 38,428 recalls
Recalled Item: RetractaBed
The Issue: All configurations of the SS Retractabed, Clinical Contour,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hudson RCI Adult Universal Ventilator Circuit
The Issue: Product is being recalled due to complaints that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Patient Control Module (PCM) is used in conjunction with
The Issue: for device malfunction resulting in flow when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN)
The Issue: Nanosphere has determined that a portion of BC-GN
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: APTIMA Urine Collection Kit
The Issue: Incorrect labeling was used on each pouch of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: enGen (TM) Laboratory Automation System Configured with TCAutomation"...
The Issue: Software anomaly: potential buffer timeout issues when using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McKesson Radiology-PACS. McKesson Radiology is a medical image and information
The Issue: High priority alert icon was not displayed in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HexaPOD evo RT Couchtop. To support and aid in positioning
The Issue: If screws are not properly tightened with a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polyflux Revaclear
The Issue: The firm received several complaints for internal blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies...
The Issue: DePuy Synthes is initiating a recall of certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tissue-Tek PARAFORM PROC/EMB/MEDIUM
The Issue: This Lot has variations in melting temperature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet PowerLED 700. Product Usage
The Issue: Maquet has identified an issue with the Maquet
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Licox Test Kit Rx Only An accessory
The Issue: Integra LifeSciences has identified through a small number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polyflux Revaclear Max
The Issue: The firm received several complaints for internal blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) -
The Issue: Patients and caregivers are instructed that if a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RAPIDFILL Syringe Strip
The Issue: breach in sterile barrier for inner and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 12-Instrument Sterilization Tray
The Issue: Gravity sterilization parameters provided in the 12 Instrument
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alere INRatio2 PT/INR Professional Test Strips
The Issue: Test Strips may report an inaccurately low INR
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ReTurn 7500/7500 Aid
The Issue: During the period of April 2009 May
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RenLane Renal Denervation Catheter
The Issue: Damage may occur to the helical tip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.