Medical device recalls
38845 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2026-02-04FDA-DevicePhilips North AmericaClass IIContact Philips about your Ingenia 3.0T MRI system
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DevicePhilips North AmericaClass IIContact Philips about your Ingenia 1.5T MRI system
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DevicePhilips North AmericaClass IIContact Philips about Evolution Upgrade 3.0T MR system
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DevicePhilips North AmericaClass IICheck Philips MRI elastography software
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DeviceCardinal Health 200, LLCClass IIStop using Cardinal Health chest drainage units on infants
The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.
- 2026-02-04FDA-DeviceZimmer Surgical IncClass IICheck your Zimmer A.T.S. 3200TS tourniquet software
Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.
- 2026-02-04FDA-DeviceZimmer Surgical IncClass IICheck your Zimmer tourniquet system software
Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.
- 2026-02-04FDA-DeviceMedline Industries, LPClass IIStop using affected Medline surgical kits
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
- 2026-02-04FDA-DeviceMedline Industries, LPClass IIStop using affected Medline C-section kits
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
- 2026-02-04FDA-DeviceMedline Industries, LPClass IIStop using Medline circumcision procedure kit
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
- 2026-02-04FDA-DeviceMedline Industries, LPClass IIStop using Medline surgical procedure kits
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
- 2026-02-04FDA-DeviceMedline Industries, LPClass IIStop using affected Medline neuro procedure kits
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
- 2026-02-04FDA-DeviceMedline Industries, LPClass IICheck Medline procedure kits for cracked adhesive applicators
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
- 2026-02-04FDA-DeviceMedline Industries, LPClass IIStop using Medline HEAD SHAVE-LATEX SAFE KIT
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
- 2026-02-04FDA-DeviceMedline Industries, LPClass IIStop using recalled Medline procedure kits
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
- 2026-02-04FDA-DeviceMedline Industries, LPClass IIStop using affected Medline procedure kits
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
- 2026-02-04FDA-DeviceMedline Industries, LPClass IICheck your Medline surgical kit lot numbers
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
- 2026-02-04FDA-DeviceMedline Industries, LPClass IIStop using affected Medline procedure kits
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
- 2026-02-04FDA-DeviceMedline Industries, LPClass IIStop using affected Medline procedure kits
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
- 2026-02-04FDA-DeviceMedline Industries, LPClass IIStop using affected Medline procedure kits
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
- 2026-02-04FDA-DeviceMedline Industries, LPClass IIStop using affected Medline procedure kits
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
- 2026-02-04FDA-DeviceMedline Industries, LPClass IIStop using Medline Nerve Block Tray 2 kits
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
- 2026-02-04FDA-DeviceNIPRO Technical Services, Inc.Class IIStop using NIPRO Conductivity Standard Solution
due to a defect associated with the conductivity values of the solution used to calibrate meters and result in the reporting of incorrect conductivity values for dialysate.
- 2026-02-04FDA-DeviceGOLD STAR DISTRIBUTION INCClass IIStop using Gold Star Distribution pregnancy tests
Potential exposure of rodents and rodent activity in the distribution center.
- 2026-02-04FDA-DeviceGOLD STAR DISTRIBUTION INCClass IIStop using recalled Oral-B and Colgate toothbrushes
Potential exposure of rodents and rodent activity in the distribution center.
- 2026-02-04FDA-DeviceGOLD STAR DISTRIBUTION INCClass IIStop using recalled feminine hygiene products
Potential exposure of rodents and rodent activity in the distribution center.
- 2026-02-04FDA-DeviceGOLD STAR DISTRIBUTION INCClass IIStop using recalled Trojan condoms
Potential exposure of rodents and rodent activity in the distribution center.
- 2026-02-04FDA-DeviceGOLD STAR DISTRIBUTION INCClass IIStop using Gold Star first aid kits and bandages
Potential exposure of rodents and rodent activity in the distribution center.
- 2026-02-04FDA-DeviceCanon Medical System, USA, INC.Class IICheck your Canon Medical X-ray system
It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
- 2026-02-04FDA-DeviceCanon Medical System, USA, INC.Class IICheck your Canon Medical X-ray system
It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
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