Class IIOngoingZ-1121-2025
MICROVENTION INC. recalls MicoVention Terumo
Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
MICROVENTION INC.CAFeb 19, 2025
Recalls: Nonconforming Material/Component
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 325–336 of 386 recalls
Class IIOngoingZ-1095-2025
Hologic, Inc. recalls The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN…
Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen Collection Tubes which may be empty, underfilled, or overfilled with extraction buffer.…
Hologic, Inc.CAFeb 12, 2025
Class IOngoingZ-1047-2025
ROi CPS LLC recalls regard Item Number: 830106006
There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee Resuscitator and/or Circuit will not reach the high and low ends of…
ROi CPS LLCMOFeb 12, 2025
Class IIOngoingZ-1021-2025
B. Braun Medical, Inc. recalls Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic…
Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter.…
B. Braun Medical, Inc.PAFeb 5, 2025
Class IIOngoingZ-0976-2025
CareFusion 303, Inc. recalls BD Pyxis Med 4000 Auxiliary (AUX)
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Sit…
CareFusion 303, Inc.CAJan 29, 2025
Class IIOngoingZ-0975-2025
CareFusion 303, Inc. recalls BD Pyxis Med ES Auxiliary (AUX)
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Sit…
CareFusion 303, Inc.CAJan 29, 2025
Class IIOngoingZ-0974-2025
CareFusion 303, Inc. recalls BD Pyxis MedStation 4000 AUX
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Sit…
CareFusion 303, Inc.CAJan 29, 2025
Class IIOngoingZ-0973-2025
CareFusion 303, Inc. recalls BD Pyxis MedStation 4000 Main
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Sit…
CareFusion 303, Inc.CAJan 29, 2025
Class IIOngoingZ-0972-2025
CareFusion 303, Inc. recalls BD Pyxis MedStation ES AUX
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Sit…
CareFusion 303, Inc.CAJan 29, 2025
Class IIOngoingZ-0971-2025
CareFusion 303, Inc. recalls BD Pyxis MedStation ES (Med ES Main)
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Sit…
CareFusion 303, Inc.CAJan 29, 2025
Class IIOngoingZ-0921-2025
DRG International, Inc. recalls DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
The user of the assay may either face a failure message during re-calibration of the Hybrid.XL instrument using the re-calibration R1 and R2 of the device or find controls out of specification (failed Control High) which…
DRG International, Inc…NJJan 22, 2025
Class IIOngoingZ-0917-2025
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Cardinal Health 200, L…ILJan 22, 2025