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.
- 2026-02-25FDA-DeviceMedline Industries, LPClass IIMedline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 2) TOTE SEN OSC HAND REPAIR, Model Number: DYKM1776; 3) TOTE MOMENI SB CAPSULOTOMY REC, Model Number: DYKM1765A; 4) TOTE YAO OSC HAND REPAIR, Model Number: DYKM1796A; 5) TOTE SB NGUYEN CAPSULOTOMY, Model Number: DYKM1756A; 6) TOTE FOX OSC HAND REPAIR, Model Number: DYKM1783A; 7) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A; 8) TOTE SB NGUYEN LIPOSUCTION, Model Number: DYKM1927A; 9) TOTE YA
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 Medline Lithotomy Pack 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 surgical 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 endoscopy kits for sterilization defect
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) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) MAJOR LAPAROTOMY CDS, Model Number: CDS860015W; 4) MAJOR LAPAROTOMY CDS, Model Number: CDS860015X; 5) MINOR LAPAROTOMY CDS, Model Number: CDS860016P; 6) MINOR LAPAROTOMY CDS, Model Number: CDS860016Q; 7) MINOR LAPAROTOMY CDS, Model Number: CDS860016R; 8) MINOR LAPAROTOMY CDS, Model Number: CDS860016S; 9) LAP GASTRIC BYPASS CDS, Model Number: CDS86014
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 issues
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 Dental Pack 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 IICheck Medline surgical and biopsy kits for 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 IICheck Medline surgical 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 IICheck Medline surgical 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 IICheck Medline surgical kits for sterilization problems
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 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 Medline nerve block 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 IIReturn Medline Convenience Kits to your supplier
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 tracheostomy 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 IICheck Medline surgical kits for proper sterilization
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-DeviceAuris Health, IncClass IIStop using affected Auris Health MONARCH devices
Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to patient-left position; and if right position was previously selected, this may lead to unanticipated robotic arm positioning toward patient-left, may result in contact with patient/endotracheal tube.
- 2026-02-25FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus Thunderbeat surgical instruments
Firm is initiating a removal due to continued reports of adverse events.
- 2026-02-25FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus Thunderbeat surgical devices
Firm is initiating a removal due to continued reports of adverse events.
- 2026-02-25FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus Thunderbeat surgical instruments
Firm is initiating a removal due to continued reports of adverse events.
- 2026-02-25FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus Thunderbeat surgical instruments
Firm is initiating a removal due to continued reports of adverse events.
- 2026-02-25FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus Thunderbeat surgical instruments
Firm is initiating a removal due to continued reports of adverse events.
- 2026-02-25FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus Thunderbeat surgical instruments
Firm is initiating a removal due to continued reports of adverse events.
- 2026-02-25FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus Thunderbeat surgical instruments
Firm is initiating a removal due to continued reports of adverse events.
- 2026-02-25FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus Thunderbeat 5mm instruments
Firm is initiating a removal due to continued reports of adverse events.
- 2026-02-25FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus Thunderbeat surgical instruments
Firm is initiating a removal due to continued reports of adverse events.
- 2026-02-25FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus Thunderbeat instruments
Firm is initiating a removal due to continued reports of adverse events.
- 2026-02-25FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus Thunderbeat devices
Firm is initiating a removal due to continued reports of adverse events.
- 2026-02-25FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus Thunderbeat surgical instruments
Firm is initiating a removal due to continued reports of adverse events.
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