February 25, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 2) TOTE SEN OSC HAND REPAIR, Mode
Hazard: 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.
February 25, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model
Hazard: 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.
February 25, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A;
Hazard: 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.
February 25, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY URETHROPLASTY, Model Nu
Hazard: 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.
February 25, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Numb
Hazard: 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.
February 25, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: C
Hazard: 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.
February 25, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, M
Hazard: 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.
February 25, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits: 1) DENTAL PACK, Model Number: DYNDA3003
Hazard: 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.
February 25, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP
Hazard: 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.
February 25, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Numbe
Hazard: 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.
February 25, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART CDS, Model Number: CDS840023T;
Hazard: 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.
February 25, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits: 1) OR ARTERIOGRAM, Model Number: CDS985094F; 2) KIT SURG ONC LAP DIAG/CV CATH, Model Number
Hazard: 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.
February 25, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY PACK-LF, Model Number: D
Hazard: 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.
February 25, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number: PAIN0150C
Hazard: 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.
February 25, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number: DYNJ56436
Hazard: 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.
February 25, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number: D
Hazard: 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.
February 25, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Num
Hazard: 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.
February 25, 2026Medical DevicesFDA
Auris Health, Inc recalls MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-00000
Hazard: 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.
February 25, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
Hazard: Firm is initiating a removal due to continued reports of adverse events.
February 25, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip
Hazard: Firm is initiating a removal due to continued reports of adverse events.
February 25, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip
Hazard: Firm is initiating a removal due to continued reports of adverse events.
February 25, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Thunderbeat, 5 mm, 45 cm Inline Grip
Hazard: Firm is initiating a removal due to continued reports of adverse events.
February 25, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
Hazard: Firm is initiating a removal due to continued reports of adverse events.
February 25, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip
Hazard: Firm is initiating a removal due to continued reports of adverse events.
February 25, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip
Hazard: Firm is initiating a removal due to continued reports of adverse events.
February 25, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip
Hazard: Firm is initiating a removal due to continued reports of adverse events.
February 25, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip
Hazard: Firm is initiating a removal due to continued reports of adverse events.
February 25, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S
Hazard: Firm is initiating a removal due to continued reports of adverse events.
February 25, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
Hazard: Firm is initiating a removal due to continued reports of adverse events.
February 25, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
Hazard: Firm is initiating a removal due to continued reports of adverse events.