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 21981–22000 of 38,428 recalls
Recalled Item: Sonialvision Safire II
The Issue: When selecting serial radiography with a pulse rate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Solid state x-ray imager (flat panel/digital imager) Solid state x-ray
The Issue: While transporting the portable machine with the retrofit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Knee Prosthesis
The Issue: Firm became aware that the specific product/lot combinations
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Progressa Bed - AC-powered adjustable hospital bed
The Issue: A component used within the braking system may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000) G20079 is a
The Issue: The temperature of the incubation lids of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is
The Issue: The temperature of the incubation lids of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis one fluoroscopic x-ray system and patient table Artis one
The Issue: Certain patient table systems may have a missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items
The Issue: Alcon is conducting this Voluntary Medical Device Recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy
The Issue: Alcon is conducting this Voluntary Medical Device Recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ellex I.Science iTRACK 250A
The Issue: Sterility failure found in one of the units
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products TSH Reagent Pack
The Issue: VITROS TSH reagent lots have been found to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hex Driver Part Number HXDRIVER-2.0 AO
The Issue: Following the completion of sterilization cycle(s) of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IQon Spectral CT with 4.7.2 software version.- Model 728332
The Issue: 23 Software related issues for the IQon Spectral
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The
The Issue: CARESCAPE Central Station (CSCS) software version 2.0.2 units
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet
The Issue: Three (3) lots were distributed with the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet
The Issue: Three (3) lots were distributed with the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet
The Issue: Three (3) lots were distributed with the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syngo.via software is intended to be used for viewing
The Issue: When the archiving configuration is changed, data received/created
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style
The Issue: Product is labeled with "CE", but is not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LeadCare II Blood Lead Analyzer Part Numbers: 70-6760
The Issue: The incorrect placement of AA batteries into certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.