Medical device recalls

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

801–825 of 13399

HighFDA (Devices)·Z-1435-2026·2026-03-04
Meijer Saline Wound Wash Recalled Due to Sterility Assurance Level Failure
Medline Industries is recalling Meijer STERILE saline wound wash because the manufacturer may not have met required sterility standards. The recalled product was distributed nationwide in the US and internationally.
Product
Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MJSALINE7
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1474-2026·2026-03-04
Remel Campy CVA Culture Medium Fails to Recover Campylobacter Jejuni
Remel Inc. recalls Campy CVA Culture Medium lot R01272 (expired Jan 12, 2026) due to customer reports of low to no recovery of Campylobacter Jejuni. The culture medium failed to perform its intended function.
Product
Campy CVA Medium 100/PK, R01272
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1460-2026·2026-03-04
Knee and Shoulder Implants Recalled for Incorrect Labeling
Encore Medical is recalling both knee and shoulder implants due to incorrect labeling. Affected patients should contact their healthcare provider for guidance.
Product
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1458-2026·2026-03-04
Reverse Shoulder Prosthesis Implants Recalled for Incorrect Labeling
Encore Medical is recalling RSP HUMERAL SOCKET INSERT implants (Model 509-00-432, Lot 385P1263) due to incorrect labeling. The implants were distributed nationwide across multiple states.
Product
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1459-2026·2026-03-04
Knee and Humeral Socket Implants Recalled for Incorrect Labeling
Encore Medical is recalling EMPOWR 3D KNEE implants due to incorrect labeling. Patients and healthcare providers should contact the manufacturer for guidance.
Product
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1461-2026·2026-03-04
PIE Trolley System Model 2005 Recalled for Lack of FDA 510K Clearance
Edermy LLC is recalling the PIE Trolley System Model 2005 because the device was distributed without required FDA 510(k) clearance. The recall affects 27 units distributed nationwide across 18 states.
Product
PIE Trolley System Model: 2005
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1354-2026·2026-02-25
Olympus Insufflation Unit Recalled for Software Overpressure Risk
Olympus is recalling 485 High Flow Insufflation Units nationwide due to a software algorithm defect that may cause overpressure during laparoscopic surgery.
Product
Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1353-2026·2026-02-25
Olympus High Flow Insufflation Unit recalled for overpressure software defect
Olympus Corporation recalls 744 High Flow Insufflation Units (Model UHI-2) nationwide due to a software algorithm issue that may cause overpressure events during laparoscopic surgery.
Product
Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1352-2026·2026-02-25
Olympus High Flow Insufflation Unit software defect may cause overpressure
Olympus Corporation recalled 18 High Flow Insufflation Units nationwide due to a software algorithm issue that may lead to overpressure events during laparoscopic surgery.
Product
Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1406-2026·2026-02-25
Medline Surgical Drape Pack Recall Due to Sterilization Equipment Calibration Issues
Medline is recalling surgical drape packs due to sterilization equipment calibration issues that could compromise sterility levels. No illnesses have been reported.
Product
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1378-2026·2026-02-25
Olympus Thunderbeat Surgical Instrument Recalled Due to Adverse Events
Olympus Corporation of the Americas is recalling 3,381 units of its Olympus Thunderbeat surgical instrument worldwide due to continued reports of adverse events.
Product
Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1402-2026·2026-02-25
Medline Surgical Convenience Kits Recalled for Sterilization Failure Risk
Medline is recalling 684 surgical convenience kits due to equipment calibration issues that may have compromised sterility assurance levels. Affected devices may not meet required sterilization standards.
Product
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1366-2026·2026-02-25
Medline IV Administration and Extension Sets: Connector Defect Risk
Medline Industries is recalling 926,227 units of IV Administration and Extension Sets due to potential male luer connector defects that may leak, crack, or break during use, risking treatment delays, infection, blood loss, or air embolism.
Product
Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529; 2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029; 3) DBD-IVEXTSET2.4ML2 NEEDLE-FREEVLVE,35, Model Number: DYNDTB1516; 4) DBD-IV ADMIN SE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1362-2026·2026-02-25
Teslatome Bipolar Sphincterotomes Recalled for Material Void Defect
Wilson-Cook is recalling Teslatome Bipolar Sphincterotomes due to material voids that could cause inappropriate electrical current during cutting procedures. The recall affects 153 units distributed in four U.S. states.
Product
Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulation of the ductal system and for sphincterotomy. If preloade
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1405-2026·2026-02-25
Medline Convenience Kits Recalled Due to Sterilization Equipment Calibration Issues
Medline is recalling 108 Convenience Kits nationwide due to sterilization equipment calibration defects that could compromise sterility assurance on medical closure devices.
Product
Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1365-2026·2026-02-25
CVS Wound Care Dressing Recalled for Potential Sterile Packaging Failures
Integra LifeSciences is recalling CVS private-label wound dressing (Model CVS405406) due to potential packaging failures that could compromise the sterile barrier. No injuries have been reported.
Product
Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducive to wound healing. Intended for minor scalds & burns, minor cuts, lacerations & minor abrasions.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1395-2026·2026-02-25
Medline Surgical Convenience Kits Recalled Due to Sterilization Calibration Issues
Medline is recalling 82,597 surgical device kits nationwide due to equipment calibration issues that could affect sterilization quality. The kits were used in various surgical procedures.
Product
Medline 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: CD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1381-2026·2026-02-25
FDA Recalls Olympus Thunderbeat Surgical Device for Adverse Events
Olympus is recalling the Thunderbeat surgical device model TB-0520IC due to continued reports of adverse events. The recall affects 140 units distributed worldwide.
Product
Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1385-2026·2026-02-25
Medline tracheostomy kits recalled for sterilization equipment calibration issues
Medline is recalling 753 tracheostomy convenience kits due to calibration issues in sterilization equipment that could affect sterility assurance level.
Product
Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55A; 3) TRACH TOTE, Model Number: DYNJ85691
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1398-2026·2026-02-25
Medline Lithotomy Packs Recalled for Sterilization Equipment Calibration Issues
Medline has recalled lithotomy packs due to calibration issues with sterilization equipment that may compromise sterility assurance. Affected units were distributed nationwide and worldwide.
Product
Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1408-2026·2026-02-25
Medline PPE Convenience Kit Sterilization Calibration Issue Recall
Medline is recalling approximately 7,575 PPE Convenience Kits (Model DYK1011945P) due to sterilization equipment calibration issues that may compromise device sterility. Affected products were distributed nationwide.
Product
Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1411-2026·2026-02-25
Medline Convenience Kits Recalled Over Sterilization Equipment Calibration Issues
Medline is recalling 9,720 sterilized medical device kits due to sterilization equipment calibration problems that may compromise their sterility assurance levels.
Product
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035A; 2) LVAD DRIVELINE TRAY, Model Number: DM1035; 3) CENTRAL LINE DRESSING CHANGE TRAY, Model Number: DT8670A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1393-2026·2026-02-25
Medline Dental Pack Kits Recalled for Sterilization Equipment Calibration Issues
Medline is recalling Dental Pack convenience kits (Model DYNDA3003) due to calibration issues in sterilization equipment that may compromise sterility assurance. Healthcare providers should stop use and contact Medline for replacement.
Product
Medline Convenience Kits: 1) DENTAL PACK, Model Number: DYNDA3003
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1407-2026·2026-02-25
Medline Triple Lumen Catheter Insertion Kit Recalled Due to Sterilization Concerns
Medline is recalling a triple lumen catheter insertion kit (Model DYNDM1031A) due to potential sterility issues caused by equipment calibration problems during sterilization and packaging.
Product
Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1369-2026·2026-02-25
Estrone RIA diagnostic kit may produce falsely elevated results
Certain lots of Estrone RIA diagnostic kits may rarely produce falsely elevated test results that could lead to temporary injury in rare cases. The kits were distributed worldwide including North Carolina.
Product
Estrone RIA, REF: DSL8700
Category
Medical Device
Distribution
Distributed nationwide

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