Medical Device Recalls | FDA Device Safety Alerts And Recall Notices

Medical Device Recall Alerts List

Showing 626 - 650 of 1,678 matching product recalls.

Product Recall	Source	Type	Risk	Date	Action
See RES for complete list. 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: CDS860016P; 6) MINOR LAPAROTOMY CDS, Model Number: CDS860016Q; 7) MINOR LAPAROTOMY CDS, Model Number: CDS860016R; 8) MINOR LAPAROTOMY CDS, Model Number: CDS860016S; 9) LAP GASTRIC BYPASS CDS, Model Number: CDS860146M; 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-2098-2026	Medical Device	High	May 13, 2026 Recall: Jan 7, 2026	Details
Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36. 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-1971-2026	Medical Device	High	May 13, 2026 Recall: Mar 13, 2026	Details
See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number: CDS981504G; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407P; 3) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 4) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 5) NHP ROBOTIC GYNE CDS, Model Number: CDS984243G; 6) ROBOTIC-LF, Model Number: CDS984543D; 7) ROBOTIC-LF, Model Number: CDS984543F; 8) ROBOTIC-LF, Model Number: CDS984543G; 9) ROBOTIC-LF, Model Number: CDS984543I; 10) GYN CDS, Model Number: CDS984860F; 11) GYN LAP PELVI, Model Number: CDS985423G; 12) GYN KIT, Model Number: DYKM1657A; 13) KIT G 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-2109-2026	Medical Device	High	May 13, 2026 Recall: Jan 7, 2026	Details
Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55A; 3) TRACH TOTE, Model Number:DYNJ85691 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-2115-2026	Medical Device	High	May 13, 2026 Recall: Jan 7, 2026	Details
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000 Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk	FDA Z-1942-2026	Medical Device	High	May 13, 2026 Recall: Mar 25, 2026	Details
DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23 Field Safety Corrective Action for IFU in DEX Forceps and Scissors.	FDA Z-2073-2026	Medical Device	High	May 13, 2026 Recall: Mar 25, 2026	Details
Uric Acid in vitro diagnostic test REF: 31H0P The devices were distributed without required FDA premarket clearance or approval.	FDA Z-2086-2026	Medical Device	High	May 13, 2026 Recall: Apr 2, 2026	Details
DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25 Field Safety Corrective Action for IFU in DEX Forceps and Scissors.	FDA Z-2070-2026	Medical Device	High	May 13, 2026 Recall: Mar 25, 2026	Details
Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR ARTERIOGRAM, Model Number:CDS985094F; 3) INTRAVASOR CATH KIT, Model Number:DYK1060193I; 4) KIT SURG ONC LAP DIAG/CV CATH, Model Number:DYKMBNDL153; 5) KIT ACES INSERT PERCUTANEOUS T, Model Number:DYKMBNDL4A; 6) KIT ACES INSERT PERCUTANEOUS T, Model Number:DYKMBNDL4B; 7) VEIN PROCEDURE KIT, Model Number:DYNDA2076C; 8) CARDIAC CATH PACK-LF, Model Number:DYNJ0150605AC; 9) CARDIAC CATH PACK-LF, Model Number:DYNJ0368386D; 10) CATH LAB PACK-LF, Model Number:DYNJ0648473Y; 11) NBMC CATH PACK-LF, Model Number:DYNJ0803367 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-2092-2026	Medical Device	High	May 13, 2026 Recall: Jan 7, 2026	Details
Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number:DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number:DYKMBNDL87A; 3) CT BIOPSY TRAY, Model Number:DYNDH1143C; 4) BIOPSY SPECIALS PACK, Model Number:DYNDH1873; 5) BIOPSY SPECIALS PACK, Model Number:DYNDH1934; 6) BREAST BIOPSY PACK, Model Number:DYNJ17489I; 7) C T BIOPSY TRAY-LF, Model Number:DYNJ17558D; 8) RIGHT HEART BIOPSY TRAY, Model Number:DYNJ19063K; 9) VOR PACK-LF, Model Number:DYNJ48539; 10) VOR PACK-LF, Model Number:DYNJ48539A; 11) IR BIOPSY PACK, Model Number:DYNJ59897B; 12) BREAST PACK, Model Number:DYNJ8299 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-2095-2026	Medical Device	High	May 13, 2026 Recall: Jan 7, 2026	Details
Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all basic physiologic parameters. The Command Module inserts into the side of a Spacelabs patient monitor. A variety of configurations can be selected to suit the monitoring needs of specific patients or care units in the hospital. Component: N/A Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).	FDA Z-2052-2026	Medical Device	High	May 13, 2026 Recall: Mar 26, 2026	Details
Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential risk for biohazard exposure, blood loss, infection, or air embolism.	FDA Z-1981-2026	Medical Device	High	May 13, 2026 Recall: Mar 19, 2026	Details
Medline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ87157, Model Number: GULLO SURGICAL 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-2096-2026	Medical Device	High	May 13, 2026 Recall: Jan 7, 2026	Details
Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number:DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number:DYNJ56436B; 3) SCC RF PAIN MGMT, Model Number:DYNJ56436C; 4) CPNB SETUP TRAY, Model Number:DYNJRA1979; 5) CPNB SETUP TRAY, Model Number:DYNJRA1979A; 6) CPNB SETUP TRAY, Model Number:DYNJRA1979B; 7) VARITHENA TRAY 2, Model Number:DYNJRA2608; 8) CPNB SETUP TRAY, Model Number:SAMPA0108 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-2090-2026	Medical Device	High	May 13, 2026 Recall: Jan 7, 2026	Details
Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number:PAIN0150C 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-2116-2026	Medical Device	High	May 13, 2026 Recall: Jan 7, 2026	Details
LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-001938, 99577-000045; LIFEPAK 1000, REF: 99425-000025, 99425-000023, 99425-000096; LIFEPAK 35, REF: 99335-000013, 99335-000031; LIFEPAK 20e, REF: 99507-000122 Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy.	FDA Z-2065-2026	Medical Device	High	May 13, 2026 Recall: Apr 13, 2026	Details
See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Model Number:CDS840015AQ; 3) OPEN HEART CDS, Model Number:CDS840023T; 4) OFF PUMP CABG CDS, Model Number:CDS840087AI; 5) OFF PUMP CABG CDS, Model Number:CDS840087AK; 6) OFF PUMP CABG CDS, Model Number:CDS840087AL; 7) OFF PUMP CABG CDS, Model Number:CDS840087AM; 8) OPEN HEART, Model Number:CDS840150S; 9) OPEN HEART, Model Number:CDS840150T; 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-2093-2026	Medical Device	High	May 13, 2026 Recall: Jan 7, 2026	Details
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement. Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.	FDA Z-2050-2026	Medical Device	High	May 13, 2026 Recall: Mar 20, 2026	Details
Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A; 3) LAP BASIN, Model Number: DYNJVB91109D 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-2100-2026	Medical Device	High	May 13, 2026 Recall: Jan 7, 2026	Details
One Step K in vitro diagnostic test REF: 81A4 The devices were distributed without required FDA premarket clearance or approval.	FDA Z-2087-2026	Medical Device	High	May 13, 2026 Recall: Apr 2, 2026	Details
Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P 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-2104-2026	Medical Device	High	May 13, 2026 Recall: Jan 7, 2026	Details
Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L 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-2119-2026	Medical Device	High	May 13, 2026 Recall: Jan 7, 2026	Details
Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05. 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-1972-2026	Medical Device	High	May 13, 2026 Recall: Mar 13, 2026	Details
See RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) BREAST-HERNIA-PORT CDS-LF, Model Number: CDS984853J; 3) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 4) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158; 5) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170; 6) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170A; 7) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170B; 8) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182; 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-2099-2026	Medical Device	High	May 13, 2026 Recall: Jan 7, 2026	Details
Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.	FDA Z-1965-2026	Medical Device	High	May 6, 2026 Recall: Apr 14, 2026	Details

Showing 626 - 650 of 1,678 product recalls

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