Medical device recalls

FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.

851–875 of 13399

HighFDA (Devices)·Z-1421-2026·2026-02-25
Medline Surgical Kits Recalled Due to Sterilization Equipment Calibration Issues
Medline is recalling surgical convenience kits used in orthopedic procedures due to sterilization equipment calibration issues that could compromise sterility assurance. The recall affects approximately 117,907 units distributed nationwide.
Product
Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6) TOTAL KNEE CDS-
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1380-2026·2026-02-25
Olympus Thunderbeat Surgical Instrument Recalled for Adverse Events
Olympus Corporation of the Americas is recalling the Olympus Thunderbeat surgical instrument due to continued reports of adverse events. Approximately 52 units were distributed worldwide.
Product
Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1423-2026·2026-02-25
Medline Surgical Drapes Recalled Due to Sterilization Equipment Calibration Issues
Medline Industries is recalling over 14 million surgical drapes due to sterilization equipment calibration issues that could compromise product sterility. No illnesses or injuries have been reported.
Product
Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,ECONOMY,40X58",ST,20/CS, Model Number: DYNJP2411; 3) SHEET,DRAPE, 40X70,STERILE, Model Number: DYNJP2412; 4) DRAPE,MEDIUM,TAPE,40X70",ST,50/CS, Model Number: DYNJP2412T; 5) SHE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1426-2026·2026-02-25
Prodisc C SK Cervical Implants Recalled for Mislabeling of Device Size
Centinel Spine is recalling 20 Prodisc C SK cervical disc replacements because units were mislabeled as 6mm but contained 5mm products. Affected devices were distributed in multiple US states.
Product
Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1372-2026·2026-02-25
Olympus Thunderbeat Device Recalled Due to Adverse Events
Olympus Corporation of the Americas is recalling the Olympus Thunderbeat 5 mm, 35 cm device due to continued adverse event reports. Approximately 88,268 units are affected across worldwide distribution.
Product
Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1374-2026·2026-02-25
Olympus Thunderbeat Surgical Instrument Recalled Due to Adverse Events
Olympus is recalling all lots of the Thunderbeat ultrasonic surgical instrument worldwide due to continued reports of adverse events.
Product
Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1409-2026·2026-02-25
Medline Convenience Kits Recalled Due to Sterilization Equipment Calibration Issues
Medline is recalling two medical device convenience kits due to calibration issues with sterilization equipment that could impact product sterility.
Product
Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1379-2026·2026-02-25
Olympus Thunderbeat Surgical Device Recalled for Adverse Events
Olympus Corporation is recalling the Olympus Thunderbeat 5 mm surgical device due to continued reports of adverse events. The device was distributed worldwide including the United States.
Product
Olympus Thunderbeat, 5 mm, 45 cm Inline Grip
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1410-2026·2026-02-25
Medline Admission Kits Recalled Due to Sterilization Equipment Calibration Issues
Medline is recalling Admission Kits (Model DYKA1343A) due to calibration problems in sterilization equipment that could compromise the sterility of the devices. The recall affects 1,070 units distributed nationwide.
Product
Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1371-2026·2026-02-25
Olympus Thunderbeat surgical instrument recalled due to adverse events
Olympus Corporation is recalling 9,542 Thunderbeat surgical instruments worldwide due to continued reports of adverse events. Users should contact the manufacturer for instructions.
Product
Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1367-2026·2026-02-25
Central Venous Catheters Recalled Due to Potential Sterile Barrier Compromise
Bard is recalling approximately 14,935 central venous catheters (Broviac and Hickman brands) because outer tray damage may compromise the sterile barrier.
Product
Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1383-2026·2026-02-25
Bronchoscopy System Software Bug Could Cause Unexpected Robotic Arm Positioning
Auris Health MONARCH Platform bronchoscopy systems are affected by a software defect where the application may reinitialize to an incorrect position after restart, potentially causing the robotic arm to contact the patient's airway.
Product
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1386-2026·2026-02-25
Medline convenience kits recalled for sterilization equipment calibration issues
Medline is recalling 779 units of five convenience kit models due to calibration issues in sterilization equipment. These issues may compromise the sterility assurance of affected devices.
Product
Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number: DYNJ56436B; 3) CPNB SETUP TRAY, Model Number: DYNJRA1979; 4) CPNB SETUP TRAY, Model Number: DYNJRA1979A; 5) CPNB SETUP TRAY, Model Number: SAMPA0108
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1363-2026·2026-02-25
Medical wound dressing recalled due to potential sterile packaging failures
Integra LifeSciences is recalling MediHoney Gel wound dressings due to potential packaging failures that could breach the sterile barrier. The recall affects 49,367 units distributed worldwide.
Product
MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing with Active Leptospermum Honey provides a moist environment conducive to wound healing and is indicated for light to moderately exuding wounds.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1401-2026·2026-02-25
Medline Medical Device Kits Recalled Due to Sterilization Equipment Calibration Issues
Medline is recalling 553 convenience kits used in medical procedures due to calibration issues with sterilization equipment that could compromise device sterility. No illnesses or injuries have been reported.
Product
Medline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 2) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4; 4) NICU LINE CHANGE TRAY, Model Number: LC295; 5) OSC SHERMAN KNEE ARTHRO BASIC, M
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1387-2026·2026-02-25
Medline nerve block tray recalled over sterilization equipment calibration
Medline recalls 448 units of Basic Nerve Block Trays due to equipment calibration issues that may affect sterilization assurance levels of the medical devices.
Product
Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number: PAIN0150C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1418-2026·2026-02-25
Medline Surgical Convenience Kits Recalled for Sterilization Calibration Issues
Medline is recalling surgical and gynecological convenience kits due to calibration issues with sterilization and packaging equipment that could compromise sterility assurance. No illnesses have been reported to date.
Product
Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) MINOR VAGINAL #76-RF, Mod
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1412-2026·2026-02-25
Medline Convenience Kits Recalled for Potential Sterility Issues
Medline Industries is recalling certain Chest/Breast-LF Convenience Kits due to equipment calibration issues that could compromise sterility assurance during sterilization and packaging. The affected kits were distributed nationwide.
Product
Medline Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1376-2026·2026-02-25
Olympus Thunderbeat Surgical Device Recalled for Reported Adverse Events
Olympus Corporation is recalling the Thunderbeat 5 mm surgical device due to continued reports of adverse events. The device has been distributed worldwide, including throughout the United States.
Product
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1419-2026·2026-02-25
Medical Device Surgical Kits Recalled for Sterilization Equipment Calibration Issues
Medline is recalling 31 models of surgical instrument kits due to calibration issues with sterilization equipment that could affect sterility assurance. The recall affects approximately 7,725 units distributed nationwide.
Product
Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431O; 4) KIT ROBOTICS GYN, Model Number: DYKMBNDL109A; 5) KIT ROBOTICS UROLOGY PROSTA
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1399-2026·2026-02-25
Medline Convenience Kits Recalled Due to Sterilization Calibration Issues
Medline Industries recalls 154,427 sterilized medical convenience kits due to calibration issues with sterilization and packaging equipment that may impact sterility assurance. No illnesses have been reported.
Product
Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER #5, Model Number: ACC010475; 4) DRAWER 1 NEURO CART, Model Number: ACC010542; 5) DRAWER 2 NEURO CART, Model Number: ACC01054
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1389-2026·2026-02-25
Medline surgical and catheterization kits recalled for sterilization calibration issues
Medline is recalling 30,958 Convenience Kits for surgical and catheterization procedures due to calibration issues with sterilization equipment that could compromise sterility assurance levels.
Product
Medline Convenience Kits: 1) OR ARTERIOGRAM, Model Number: CDS985094F; 2) KIT SURG ONC LAP DIAG/CV CATH, Model Number: DYKMBNDL153; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4A; 4) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4B; 5) VEIN PROCEDURE
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1403-2026·2026-02-25
Medline Convenience Kits Recalled Due to Potential Sterility Compromise
Medline Industries is recalling convenience kits due to calibration problems with sterilization equipment that could affect whether devices remain sterile.
Product
Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1382-2026·2026-02-25
Olympus Thunderbeat Surgical Instrument Recall Due to Adverse Events
Olympus is recalling approximately 1,538 Thunderbeat surgical instruments due to continued reports of adverse events. Affected devices are being removed from distribution.
Product
Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1388-2026·2026-02-25
Medline Convenience Kits Sterility Assurance Recall
Medline is recalling 3,561 convenience kits due to calibration issues with sterilization equipment that may compromise sterility assurance. No illnesses have been reported.
Product
Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY PACK-LF, Model Number: DYNJ0800934D; 3) GENERAL ENDO PACK-LF, Model Number: DYNJ0842873J; 4) OR ANGIO PACK-LF, Model Number: DYNJ43415C; 5) ANGIO PACK II, Model Number: DYNJ44066
Category
Medical Device
Distribution
Distributed nationwide

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