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.
13,791 stored notices, reported between Jun 20, 2012 and Oct 28, 2026. Newest first.
Reported Jan 21, 2026
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Elekta, Inc.
FDA (openFDA device enforcement)
Reported Jan 21, 2026
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
FDA (openFDA device enforcement)
Reported Jan 21, 2026
SMV DSX New Line, System, Tomography, Computed, Emission
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ge Medical Systems Israel, Functional Imaging
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 21, 2026
BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hangzhou Bever Medical Devices Co., Ltd.
FDA (openFDA device enforcement)
Reported Jan 21, 2026
Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Heraeus Medical GmbH (Dental Division)
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 21, 2026
ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hologic, Inc.
FDA (openFDA device enforcement)
Reported Jan 21, 2026
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
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 Jan 21, 2026
Plum Duo Infusion System, List Number 40002-04-01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
FDA (openFDA device enforcement)
Reported Jan 21, 2026
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory
FDA (openFDA device enforcement)
Reported Jan 21, 2026
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
FDA (openFDA device enforcement)
Reported Jan 21, 2026
Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medicrea International
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 21, 2026
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: AN01 CAROTID ANESTH…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries, LP
17 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 21, 2026
Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
FDA (openFDA device enforcement)
Reported Jan 21, 2026
A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported Jan 21, 2026
Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mobius Imaging, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 21, 2026
Product Name: Allura Xper FD10C; Model number: 722001;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
17 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 21, 2026
MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Repligen Corporation
FDA (openFDA device enforcement)
Reported Jan 21, 2026
CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Thoratec LLC
FDA (openFDA device enforcement)
Reported Jan 14, 2026
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abiomed, Inc.
FDA (openFDA device enforcement)
Reported Jan 14, 2026
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Applied Medical Resources Corp.
FDA (openFDA device enforcement)
Reported Jan 14, 2026
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
High riskUsing this product could cause serious injury, illness or death — stop using it now.AVID Medical, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 14, 2026
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 14, 2026
BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
FDA (openFDA device enforcement)
Reported Jan 14, 2026
Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.IMRIS Imaging Inc.
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.