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 28, 2026
Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MicroPort Orthopedics Inc.
FDA (openFDA device enforcement)
Reported Jan 28, 2026
Philips Azurion system; Software Version Number: R3.1;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
FDA (openFDA device enforcement)
Reported Jan 28, 2026
Patient Information Center iX; Software Version Number: 4.5.0
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
FDA (openFDA device enforcement)
Reported Jan 28, 2026
RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
8 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 28, 2026
TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sysmex America, Inc.
FDA (openFDA device enforcement)
Reported Jan 28, 2026
Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tyber Medical
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 21, 2026
FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abbott Diabetes Care, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 21, 2026
Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
FDA (openFDA device enforcement)
Reported Jan 21, 2026
Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.C-Rad Positioning Ab
FDA (openFDA device enforcement)
Reported Jan 21, 2026
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Canon Medical System, USA, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 21, 2026
Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Diagnostica Stago, Inc.
FDA (openFDA device enforcement)
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)
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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.