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.
- 2026-03-04FDA-DeviceHitachi, Ltd. Radiation Oncology Systems, KashiwanohaClass IICheck Hitachi Proton Beam Therapy positioning
Software anomaly in the patient positioning system may result in positional discrepancy.
- 2026-03-04FDA-DeviceHitachi, Ltd. Radiation Oncology Systems, KashiwanohaClass IICheck Hitachi proton therapy system positioning
Software anomaly in the patient positioning system may result in positional discrepancy.
- 2026-02-25FDA-DeviceIntuitive Surgical, Inc.Class IICheck your Da Vinci 5 console software version
An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.
- 2026-02-25FDA-DeviceStryker CorporationClass IICheck your Stryker MOLLI 2 system serial number
Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedures.
- 2026-02-25FDA-DeviceCentinel Spine, Inc.Class IIContact Centinel Spine about Prodisc C SK disc replacement
Products were mislabeled as the 6mm product but included the 5 mm product.
- 2026-02-25FDA-DeviceMedline Industries, LPClass IICheck your Medline surgical packs
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- 2026-02-25FDA-DeviceMedline Industries, LPClass IIStop using recalled Medline surgical gowns
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- 2026-02-25FDA-DeviceMedline Industries, LPClass IICheck Medline surgical drapes for sterilization defects
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- 2026-02-25FDA-DeviceMedline Industries, LPClass IICheck Medline arthroscopy kits for sterilization defects
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- 2026-02-25FDA-DeviceMedline Industries, LPClass IICheck Medline surgical kits for sterilization issue
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- 2026-02-25FDA-DeviceMedline Industries, LPClass IICheck Medline surgical kits for sterilization recall
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- 2026-02-25FDA-DeviceMedline Industries, LPClass IICheck Medline surgical kit lot numbers
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- 2026-02-25FDA-DeviceMedline Industries, LPClass IIStop using affected Medline surgical kits
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- 2026-02-25FDA-DeviceMedline Industries, LPClass IIStop using recalled Medline C-section kits
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- 2026-02-25FDA-DeviceMedline Industries, LPClass IIStop using affected Medline urology kits
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- 2026-02-25FDA-DeviceMedline Industries, LPClass IIStop using affected Medline surgical kits
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- 2026-02-25FDA-DeviceMedline Industries, LPClass IICheck Medline delivery kits for sterilization concerns
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- 2026-02-25FDA-DeviceMedline Industries, LPClass IIStop using Medline neuro surgical kits
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- 2026-02-25FDA-DeviceMedline Industries, LPClass IICheck Medline Convenience Kit lot numbers
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- 2026-02-25FDA-DeviceMedline Industries, LPClass IIStop using affected Medline medical trays
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- 2026-02-25FDA-DeviceMedline Industries, LPClass IIStop using Medline Admit Kit DYKA1343A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- 2026-02-25FDA-DeviceMedline Industries, LPClass IIStop using Medline Convenience Kits
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- 2026-02-25FDA-DeviceMedline Industries, LPClass IICheck your Medline PPE kit lot number
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- 2026-02-25FDA-DeviceMedline Industries, LPClass IIStop using Medline triple lumen insertion kit
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- 2026-02-25FDA-DeviceMedline Industries, LPClass IIStop using Medline DRAPE PACK-CHOICE kits
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- 2026-02-25FDA-DeviceMedline Industries, LPClass IIMedline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- 2026-02-25FDA-DeviceMedline Industries, LPClass IIStop using Medline burn care kits
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- 2026-02-25FDA-DeviceMedline Industries, LPClass IIStop using Medline Convenience Kits DYNJ50806L
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- 2026-02-25FDA-DeviceMedline Industries, LPClass IICheck Medline surgical kits for recall
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- 2026-02-25FDA-DeviceMedline Industries, LPClass IIStop using Medline convenience kits
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
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