Medical Device Recalls | FDA Device Safety Alerts And Recall Notices

Medical Device Recall Alerts List

Showing 576 - 600 of 1,678 matching product recalls.

Product Recall	Source	Type	Risk	Date	Action
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) LVAD DRIVELINE TRAY, Model Number: DM1035A; 3) CENTRAL LINE DRESSING CHANGE TRAY, Model Number: DT8670A 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.	FDA Z-2125-2026	Medical Device	High	May 13, 2026 Recall: Jan 7, 2026	Details
Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CS, Model Number: DYNJP8401 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.	FDA Z-2130-2026	Medical Device	High	May 13, 2026 Recall: Jan 7, 2026	Details
Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A; 2) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A; 3) TOTE CHANGE OSC HAND REPAIR, Model Number: DYKM1751A; 4) TOTE SB NGUYEN CAPSULOTOMY, Model Number: DYKM1756A; 5) TOTE MOMENI SB CAPSULOTOMY REC, Model Number: DYKM1765A; 6) TOTE SAFRAN OSC HIP ARTHRSCPY, Model Number: DYKM1767B; 7) TOTE SEN OSC HAND REPAIR, Model Number: DYKM1776; 8) TOTE CURTIN OSC HAND REPAIR, Model Number: DYKM1781A; 9) TOTE FOX OSC HAND REPAIR, Model Number: DYKM1783A; 10) TOTE YAO OSC HAND REPAIR, Model Number: DYKM1796A; 11) TOTE ABRAMS KNEE ARTHROSCO 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.	FDA Z-2102-2026	Medical Device	High	May 13, 2026 Recall: Jan 7, 2026	Details
Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the syringe and manifold"	FDA Z-2007-2026	Medical Device	High	May 13, 2026 Recall: Mar 17, 2026	Details
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S Field Safety Corrective Action for IFU in DEX Forceps and Scissors.	FDA Z-2075-2026	Medical Device	High	May 13, 2026 Recall: Mar 25, 2026	Details
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S Field Safety Corrective Action for IFU in DEX Forceps and Scissors.	FDA Z-2077-2026	Medical Device	High	May 13, 2026 Recall: Mar 25, 2026	Details
Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005 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.	FDA Z-2124-2026	Medical Device	High	May 13, 2026 Recall: Jan 7, 2026	Details
One Step UTI in vitro diagnostic test REF: 3374 The devices were distributed without required FDA premarket clearance or approval.	FDA Z-2083-2026	Medical Device	High	May 13, 2026 Recall: Apr 2, 2026	Details
Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.	FDA Z-1978-2026	Medical Device	High	May 13, 2026 Recall: Mar 13, 2026	Details
DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25 Field Safety Corrective Action for IFU in DEX Forceps and Scissors.	FDA Z-2078-2026	Medical Device	High	May 13, 2026 Recall: Mar 25, 2026	Details
Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437 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.	FDA Z-2120-2026	Medical Device	High	May 13, 2026 Recall: Jan 7, 2026	Details
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S Field Safety Corrective Action for IFU in DEX Forceps and Scissors.	FDA Z-2079-2026	Medical Device	High	May 13, 2026 Recall: Mar 25, 2026	Details
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number:DYNJ905567A 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.	FDA Z-2089-2026	Medical Device	High	May 13, 2026 Recall: Jan 7, 2026	Details
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27 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.	FDA Z-2080-2026	Medical Device	High	May 13, 2026 Recall: Mar 25, 2026	Details
Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.	FDA Z-1975-2026	Medical Device	High	May 13, 2026 Recall: Mar 13, 2026	Details
Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.	FDA Z-1976-2026	Medical Device	High	May 13, 2026 Recall: Mar 13, 2026	Details
DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23 Field Safety Corrective Action for IFU in DEX Forceps and Scissors.	FDA Z-2069-2026	Medical Device	High	May 13, 2026 Recall: Mar 25, 2026	Details
Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31; 4) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38; 5) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38B; 6) L & D PACK-LF, Model Number: DYNJ0456816O; 7) L & D PACK-LF, Model Number: DYNJ0456816P; 8) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ04692S; 9) VAGINAL DELIVERY PACK, Model Number: DYNJ16621B; 10) VAGINAL DELIVERY PACK, Model Number: DYNJ16621C; 11) DELIVERY PACK-LF, Model Number: DYNJ20546 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.	FDA Z-2108-2026	Medical Device	High	May 13, 2026 Recall: Jan 7, 2026	Details
Halyard CATH LAB kit. Model Number: SACL75AM. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.	FDA Z-1973-2026	Medical Device	High	May 13, 2026 Recall: Mar 13, 2026	Details
Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780; 2) LVAD DRIVELINE TRAY, Model Number: DM1035; 3) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43 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.	FDA Z-2103-2026	Medical Device	High	May 13, 2026 Recall: Jan 7, 2026	Details
One Step 10A in vitro diagnostic test The devices were distributed without required FDA premarket clearance or approval.	FDA Z-2082-2026	Medical Device	High	May 13, 2026 Recall: Apr 2, 2026	Details
Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI4300; 2) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977C; 3) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 4) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 5) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4; 6) NICU LINE CHANGE TRAY, Model Number: LC295 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.	FDA Z-2118-2026	Medical Device	High	May 13, 2026 Recall: Jan 7, 2026	Details
Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING, Model Number: DYKMBNDL106A; 3) KIT UROLOGY PENILE REPAIR, Model Number: DYKMBNDL188; 4) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189; 5) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189A 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.	FDA Z-2126-2026	Medical Device	High	May 13, 2026 Recall: Jan 7, 2026	Details
Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simult Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.	FDA Z-2046-2026	Medical Device	High	May 13, 2026 Recall: Apr 2, 2026	Details
Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Model Number: CDSCCR611O; 4) C-SECTION, Model Number: CDSCCR611P; 5) LUD C-SECTION-LF, Model Number: DYNJ0101616I; 6) C-SECTION TRAY, Model Number: DYNJ15494G; 7) C-SECTION TRAY-LF, Model Number: DYNJ19529O; 8) C-SECTION TRAY-LF, Model Number: DYNJ19529P; 9) C-SECTION TRAY-LF, Model Number: DYNJ19529Q; 10) C-SECTION TRAY-LF, Model Number: DYNJ19529R; 11) C-SECTION TRAY-LF, Model Number: DYNJ19529S; 12) C-SECTION PACK-LF, Model Number: DYNJ21550Q; 13) C-SECTION PACK, 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.	FDA Z-2110-2026	Medical Device	High	May 13, 2026 Recall: Jan 7, 2026	Details

Showing 576 - 600 of 1,678 product recalls

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Medical Device Recalls Today

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