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 Nov 5, 2025
Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Balt USA, LLC
FDA (openFDA device enforcement)
Reported Nov 5, 2025
CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Nov 5, 2025
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Canon Medical System, USA, Inc.
FDA (openFDA device enforcement)
Reported Nov 5, 2025
Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-01…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 5, 2025
Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cepheid
FDA (openFDA device enforcement)
Reported Nov 5, 2025
9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Daye (anne's Day Ltd)
28 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 5, 2025
Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Dexcom, Inc.
FDA (openFDA device enforcement)
Reported Nov 5, 2025
Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product Description: The Endomag Magseed Pro Magnetic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Endomagnetics Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 5, 2025
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
FDA (openFDA device enforcement)
Reported Nov 5, 2025
Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Greiner Bio-One North America, Inc.
FDA (openFDA device enforcement)
Reported Nov 5, 2025
ChemoLock Bag Spike, 01 units REF: CL-10-10
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
37 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 5, 2025
IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio
High riskUsing this product could cause serious injury, illness or death — stop using it now.IMPRIS Imaging Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 5, 2025
Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medistim Asa
FDA (openFDA device enforcement)
Reported Nov 5, 2025
Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microgenics Corporation
FDA (openFDA device enforcement)
Reported Nov 5, 2025
MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MicroSurgical Technology Inc.
FDA (openFDA device enforcement)
Reported Nov 5, 2025
Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 5, 2025
Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Nov 5, 2025
SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Surgical Theater Inc.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 5, 2025
Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Trividia Health, Inc.
FDA (openFDA device enforcement)
Reported Nov 5, 2025
Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Vantive US Healthcare LLC
FDA (openFDA device enforcement)
Reported Oct 29, 2025
Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
FDA (openFDA device enforcement)
Reported Oct 29, 2025
Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.B Braun Medical Inc.
FDA (openFDA device enforcement)
Reported Oct 29, 2025
Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Oct 29, 2025
DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i…
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)
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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.