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 32361–32380 of 38,428 recalls
Recalled Item: Rusch
The Issue: Misbranding: Although the product labeling identifies the catheters
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aqauapak 728 SW
The Issue: Possibility that the nebulizer adaptor packaging may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aquapak Adaptor
The Issue: Possibility that the nebulizer adaptor packaging may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RECLAIM Distal Reamer Extension Non Sterile Intended as
The Issue: Specific lots are being recalled due to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SPECTRUM Pump
The Issue: One Service Technician may not have correctly serviced
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Aeroneb Professional Nebulizer System is a portable medical device
The Issue: Aerogen has received a small number of complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Aeroneb Professional Nebulizer System is a portable medical device
The Issue: Aerogen has received a small number of complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Aeroneb Professional Nebulizer System is a portable medical device
The Issue: Aerogen has received a small number of complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Aeroneb Professional Nebulizer System is a portable medical device
The Issue: Aerogen has received a small number of complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF
The Issue: Two malfunctions posing potential risk to patients were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Luminos Agile Max system The Luminos Agile is intended
The Issue: Two malfunctions posing potential risk to patients were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Uroskop Omnia Max system The Uroskop Omnia is a
The Issue: Two malfunctions posing potential risk to patients were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals
The Issue: Two malfunctions posing potential risk to patients were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Synthes TI Vectra Plates: TI Vectra-One" Plate 2 Level
The Issue: DePuy Synthes is initiating a voluntary medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fluid Management System P4000
The Issue: To correct software bugs that could affect the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pressure IQ Evolve Mattress
The Issue: The firm received complaints regarding multiple mattresses were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dako Autostainer Link 48 with software version Dako Link 4.0.3
The Issue: Dako is recalling the Dako Link 4.0.3 software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bionector Needleless connector. Bionector is a multi-purpose catheter accessory
The Issue: Vygon has uncovered potential problems with membrane elasticity
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of
The Issue: There is an issue related to eFilm Workstation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista¿ Mass CKMB Isoenzyme Calibrator (MMB CAL) an in
The Issue: Siemens Healthcare Diagnostics has determined that Dimension Vista®
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.