May 13, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780; 2) LVAD DRIVELINE TRAY, 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.
May 13, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A; 2) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A
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.
May 13, 2026Medical DevicesFDA
Medline Industries, LP recalls See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-
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.
May 13, 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.
May 13, 2026Medical DevicesFDA
Medline Industries, LP recalls See RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) BREAST-HERN
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.
May 13, 2026Medical DevicesFDA
Medline Industries, LP recalls See RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROT
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.
May 13, 2026Medical DevicesFDA
Medline Industries, LP recalls See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHL
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.
May 13, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ87157, Model Number: GULLO SURGICAL PACK
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.
May 13, 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.
May 13, 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 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.
May 13, 2026Medical DevicesFDA
Medline Industries, LP recalls See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Mod
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.
May 13, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR ARTERIOGRAM, Model Number:CDS98509
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.
May 13, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AA; 2) ENDO KIT W/SYRINGE, Model Number:DYKE
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.
May 13, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number:DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number:DYNJ56436B;
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.
May 13, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, 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.
May 13, 2026Medical DevicesFDA
DFI Co., Ltd. recalls One Step P in vitro diagnostic test REF: 8194
Hazard: The devices were distributed without required FDA premarket clearance or approval.
May 13, 2026Medical DevicesFDA
DFI Co., Ltd. recalls One Step K in vitro diagnostic test REF: 81A4
Hazard: The devices were distributed without required FDA premarket clearance or approval.
May 13, 2026Medical DevicesFDA
DFI Co., Ltd. recalls Uric Acid in vitro diagnostic test REF: 31H0P
Hazard: The devices were distributed without required FDA premarket clearance or approval.
May 13, 2026Medical DevicesFDA
DFI Co., Ltd. recalls QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
Hazard: The devices were distributed without required FDA premarket clearance or approval.
May 13, 2026Medical DevicesFDA
DFI Co., Ltd. recalls One Step pH in vitro diagnostic test REF: 31I4P
Hazard: The devices were distributed without required FDA premarket clearance or approval.
May 13, 2026Medical DevicesFDA
DFI Co., Ltd. recalls One Step UTI in vitro diagnostic test REF: 3374
Hazard: The devices were distributed without required FDA premarket clearance or approval.
May 13, 2026Medical DevicesFDA
DFI Co., Ltd. recalls One Step 10A in vitro diagnostic test
Hazard: The devices were distributed without required FDA premarket clearance or approval.
May 13, 2026Medical DevicesFDA
BioFire Diagnostics, LLC recalls Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Hazard: Respiratory/sore throat panel test may result in false negative results and control failures.
May 13, 2026Medical DevicesFDA
Katalyst Surgical, LLC recalls DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27
Hazard: Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding tissues during surgical procedures. These devices fall under the GMDN code 62478 entitled Ophthalmic soft-tissue surgical forceps, probe-like, single use . Double pouched in tyvek pouches, sold in boxes of 5 with an inner and outer box.
May 13, 2026Medical DevicesFDA
Katalyst Surgical, LLC recalls DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S
Hazard: Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
May 13, 2026Medical DevicesFDA
Katalyst Surgical, LLC recalls DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25
Hazard: Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
May 13, 2026Medical DevicesFDA
Katalyst Surgical, LLC recalls DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S
Hazard: Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
May 13, 2026Medical DevicesFDA
Katalyst Surgical, LLC recalls DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27
Hazard: Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
May 13, 2026Medical DevicesFDA
Katalyst Surgical, LLC recalls DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S
Hazard: Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
May 13, 2026Medical DevicesFDA
Katalyst Surgical, LLC recalls DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25
Hazard: Field Safety Corrective Action for IFU in DEX Forceps and Scissors.