FDA Device
Medical devices recalls
Latest medical devices recall events with affected products, hazards, remedies, and official sources.
FDA Device
UrgentFDA Class I
Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5
Boston Scientific Corporation
FDA Device
FDA Device
UrgentFDA Class I
Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED, MANUAL, MEDLITE
Medline Industries, LP
FDA Device
UrgentFDA Class I
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes
Abiomed, Inc.
FDA Device
UrgentFDA Class I
Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414
Medline Industries, LP
FDA Device
UrgentFDA Class I
INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set
CooperSurgical, Inc.
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UrgentFDA Class I
DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150
Bard Access Systems, Inc.
FDA Device
UrgentFDA Class I
Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636
Given Imaging Ltd.
FDA Device
UrgentFDA Class II
Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 / 14987666542965 B96693 / 14987666542972 B12183 / 14987666540671 T
Beckman Coulter Mishima K.K.
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UrgentFDA Class I
Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS
Boston Scientific Corporation
FDA Device
UrgentFDA Class I
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0
Spectra Medical Devices, Llc
FDA Device
UrgentFDA Class I
Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507
Baxter Healthcare Corporation
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FDA Device
UrgentFDA Class II
Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO charger
Therabody, Inc
FDA Device
UrgentFDA Class I
INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500
Boston Scientific Neuromodulation Corporation
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UrgentFDA Class I
MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T
Medline Industries, LP
FDA Device
UrgentFDA Class I
MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A
Medline Industries, LP
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FDA Device
UrgentFDA Class I
Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators
Hamilton Medical AG
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UrgentFDA Class I
A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
Windstone Medical Packaging, Inc.
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FDA Device
UrgentFDA Class I
Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no
Medline Industries, LP
FDA Device
UrgentFDA Class I
Automated Impella Controller (AIC), for use with left heart support blood pump
Abiomed, Inc.
FDA Device
UrgentFDA Class I
Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic Star Off Handle Manifolds
Medical Action Industries, Inc. 306
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UrgentFDA Class I
Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890
Medline Industries, LP
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FDA Device
UrgentFDA Class I
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Fresenius Kabi USA, LLC
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FDA Device
UrgentFDA Class I
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds
AVID Medical, Inc.
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UrgentFDA Class I
Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-07155-UPM
ARROW INTERNATIONAL, LLC