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 7, 2026
Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Ultrasound, LLC
FDA (openFDA device enforcement)
Reported Jan 7, 2026
Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sheathing Technologies Inc.
FDA (openFDA device enforcement)
Reported Jan 7, 2026
Material Processing Laser Products
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Shenzhen Atomstack Technologies
FDA (openFDA device enforcement)
Reported Jan 7, 2026
Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Vortex Surgical Inc.
FDA (openFDA device enforcement)
Reported Dec 31, 2025
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AGFA Healthcare Corp.
FDA (openFDA device enforcement)
Reported Dec 31, 2025
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Alcon Research LLC
FDA (openFDA device enforcement)
Reported Dec 31, 2025
BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Ireland, Inc.
FDA (openFDA device enforcement)
Reported Dec 31, 2025
BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
FDA (openFDA device enforcement)
Reported Dec 31, 2025
Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Incorporated
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 31, 2025
Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Diasol, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 31, 2025
Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 31, 2025
The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
FDA (openFDA device enforcement)
Reported Dec 31, 2025
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 31, 2025
da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
FDA (openFDA device enforcement)
Reported Dec 31, 2025
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported Dec 31, 2025
KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microbiologics Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 31, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
16 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 24, 2025
Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
FDA (openFDA device enforcement)
Reported Dec 24, 2025
Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AVID Medical, Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 24, 2025
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cepheid
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 24, 2025
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Copan Italia
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 24, 2025
Cardiosave Hybrid
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Datascope Corp.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 24, 2025
Intelerad InteleShare software, with ProViewer component
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DICOM Grid, Inc.
FDA (openFDA device enforcement)
Reported Dec 24, 2025
Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 -…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dsaart LLC
5 more products 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.