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 Feb 4, 2026
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 60500010100…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Surgical Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 28, 2026
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Jan 28, 2026
The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Ireland, Inc.
FDA (openFDA device enforcement)
Reported Jan 28, 2026
Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Community Products, LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 28, 2026
Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Edan Diagnostics
15 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 28, 2026
GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ge Medical Systems Israel, Functional Imaging
FDA (openFDA device enforcement)
Reported Jan 28, 2026
SQ40S Blood Transfusion Filter
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GVS TM, Inc.
FDA (openFDA device enforcement)
Reported Jan 28, 2026
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 28, 2026
Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
FDA (openFDA device enforcement)
Reported Jan 28, 2026
Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Leaseir Technologies Slu
FDA (openFDA device enforcement)
Reported Jan 28, 2026
Mazor X robotic guidance system REF: TPL0059
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mazor Robotics Ltd.
FDA (openFDA device enforcement)
Reported Jan 28, 2026
MEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed, REF MDR107002E; 2) Semi Electric Basic Homecare Bed,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medline Industries, LP
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 28, 2026
Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
6 more products in this recall
FDA (openFDA device enforcement)
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)
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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.