Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2025-07-09FDA-DeviceCHANGE HEALTHCARE CANADA COMPANYClass IIChange Healthcare Cardiology Hemodynamics Software
Due to complaints, software update may cause software to unexpectedly shutdown.
- 2025-07-09FDA-DeviceCHANGE HEALTHCARE CANADA COMPANYClass IIChange Healthcare Cardiology Hemo Software
Due to complaints, software update may cause software to unexpectedly shutdown.
- 2025-07-09FDA-DeviceHemoCue ABClass IIThe HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the measured whole blood glucose value by a factor of 1.112 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials. The box contains 4 vials with 25 microcuvettes in each vial.
Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency, and purity of the product. This failure could increase the probability of an incorrect test result or a delayed test result.
- 2025-07-09FDA-DeviceCORIN MEDICAL, LTD.Class IIApex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243
Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.
- 2025-07-09FDA-DevicePhilips Ultrasound, IncClass IIPhilips XL14-3 Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
- 2025-07-09FDA-DevicePhilips Ultrasound, IncClass IIPhilips X8-2t Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
- 2025-07-09FDA-DevicePhilips Ultrasound, IncClass IIPhilips X7-2t Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
- 2025-07-09FDA-DevicePhilips Ultrasound, IncClass IIPhilips X6-1 Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
- 2025-07-09FDA-DevicePhilips Ultrasound, IncClass IIPhilips X5-1 Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
- 2025-07-09FDA-DevicePhilips Ultrasound, IncClass IIPhilips VL13-5 Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
- 2025-07-09FDA-DevicePhilips Ultrasound, IncClass IIPhilips V6-2 Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
- 2025-07-09FDA-DevicePhilips Ultrasound, IncClass IIPhilips S8-3t Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
- 2025-07-09FDA-DevicePhilips Ultrasound, IncClass IIPhilips S7-3t Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
- 2025-07-09FDA-DevicePhilips Ultrasound, IncClass IIPhilips S7-2 Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
- 2025-07-09FDA-DevicePhilips Ultrasound, IncClass IIPhilips S5-1 Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
- 2025-07-09FDA-DevicePhilips Ultrasound, IncClass IIPhilips L9-3 Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
- 2025-07-09FDA-DevicePhilips Ultrasound, IncClass IIPhilips L8-4 Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
- 2025-07-09FDA-DevicePhilips Ultrasound, IncClass IIPhilips L12-4 Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
- 2025-07-09FDA-DevicePhilips Ultrasound, IncClass IIPhilips L12-3 Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
- 2025-07-09FDA-DevicePhilips Ultrasound, IncClass IIPhilips eL18-4 EMT Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
- 2025-07-09FDA-DevicePhilips Ultrasound, IncClass IIPhilips eL18-4 Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
- 2025-07-09FDA-DevicePhilips Ultrasound, IncClass IIPhilips C9-5EC Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
- 2025-07-09FDA-DevicePhilips Ultrasound, IncClass IIPhilips C5-2 Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
- 2025-07-09FDA-DevicePhilips Ultrasound, IncClass IIPhilips C5-1 Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
- 2025-07-09FDA-DevicePhilips Ultrasound, IncClass IIPhilips 3D9-3v Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
- 2025-07-09FDA-DeviceLUMITHERA INCClass IIIBrand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Product Description: Light Based Device for Dry Age Related Macular Degeneration Component: No
U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.
- 2025-07-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK-LF, REF DYNJ0151148B
Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
- 2025-07-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665
Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
- 2025-07-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B; 2) CC ADULT DRAWER 2, REF ACC010256; 3) PEDI EMERGENCY TRAY-BLUE, REF ACC010316A; 4) ADULT DRAWER 4, REF ACC010389C; 5) DRAWER 4 - SUMMIT, REF ACC010627; 6) DRAWER 3, REF ACC010898.
Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
- 2025-07-09FDA-DeviceOnkos Surgical, Inc.Class IIMy3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
Required inspections were not performed on finished product prior to release and distribution.
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