Medical device recalls
Device recalls are the largest single group in this archive, because the FDA logs corrections and removals as well as outright withdrawals. Many are handled entirely between the manufacturer and a hospital and need nothing from a patient. Each notice states who has to act.
13,634 stored notices, reported between Jun 20, 2012 and Sep 9, 2026. Newest first.
Reported Jan 24, 2024
Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
High riskUsing this product could cause serious injury, illness or death — stop using it now.Maquet Cardiovascular, LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 24, 2024
Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultrasound examination table
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Oakworks Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 24, 2024
Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 24, 2024
High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
High riskUsing this product could cause serious injury, illness or death — stop using it now.Percussionaire Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 24, 2024
INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Phase Scientific International Limited
FDA (openFDA device enforcement)
Reported Jan 24, 2024
Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported Jan 24, 2024
Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 24, 2024
Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Randox Laboratories Ltd.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 24, 2024
regard Operative LAP, Item Number 800943001; surgical convenience kit
High riskUsing this product could cause serious injury, illness or death — stop using it now.ROi CPS LLC
FDA (openFDA device enforcement)
Reported Jan 24, 2024
Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare professionals with an assortment…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sarnova HC, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 24, 2024
Medex LOGICAL CATH LAB KIT, List Number M20754
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical Asd Inc.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 24, 2024
V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)-…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
FDA (openFDA device enforcement)
Reported Jan 24, 2024
Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Waldemar Link GmbH & Co. KG (Mfg Site)
FDA (openFDA device enforcement)
Reported Jan 24, 2024
GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Intended…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Xcision Medical Systems, LLC
FDA (openFDA device enforcement)
Reported Jan 17, 2024
Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 17, 2024
Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abiomed, Inc.
9 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 17, 2024
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ambu Inc.
FDA (openFDA device enforcement)
Reported Jan 17, 2024
Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bard Peripheral Vascular Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 17, 2024
Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes: a) Product Code 50100:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
16 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 17, 2024
CD11b APC: ASR, REF: 340936, and CE, REF: 333143
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton, Dickinson and Company, BD Biosciences
FDA (openFDA device enforcement)
Reported Jan 17, 2024
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioFire Diagnostics, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 17, 2024
CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Blue Belt Technologies, Inc.
FDA (openFDA device enforcement)
Reported Jan 17, 2024
Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
FDA (openFDA device enforcement)
Reported Jan 17, 2024
MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cordis US Corp.
1 more product in this recall
FDA (openFDA device enforcement)
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RecallNow is not a government agency. Every notice above was published by the FDA, USDA FSIS or CPSC and links back to its source. Browse the whole archive.