FDA Device
Medical devices recalls
Latest medical devices recall events with affected products, hazards, remedies, and official sources.
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) ACC010308A, Catalog Number: ACC010308A
Medline Industries, LP
FDA Device
FDA Device
UrgentFDA Class I
Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150
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.
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FDA Device
UrgentFDA Class I
Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-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
FDA Device
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
FDA Device
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FDA Device
UrgentFDA Class I
MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N
Medline Industries, LP
FDA Device
UrgentFDA Class I
MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835
Medline Industries, LP
FDA Device
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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FDA Device
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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FDA Device
UrgentFDA Class I
Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP
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
FDA Device
FDA Device
UrgentFDA Class I
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds
AVID Medical, Inc.
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FDA Device
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
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FDA Device
UrgentFDA Class I
Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F
Windstone Medical Packaging, Inc.
FDA Device
FDA Device
UrgentFDA Class I
AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and
North American Rescue LLC.