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 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)
Reported Oct 29, 2025
BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 29, 2025
BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
FDA (openFDA device enforcement)
Reported Oct 29, 2025
Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit"…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
5 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 29, 2025
Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CPM Medical Consultants, LLC.
FDA (openFDA device enforcement)
Reported Oct 29, 2025
Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ge Medical Systems Israel, Functional Imaging
13 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 29, 2025
MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
FDA (openFDA device enforcement)
Reported Oct 29, 2025
HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J
Moderate riskThis product could cause temporary or reversible health problems — stop using it.HeartSine Technologies Ltd.
FDA (openFDA device enforcement)
Reported Oct 29, 2025
One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Home Health US, Incorporated
FDA (openFDA device enforcement)
Reported Oct 29, 2025
IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm)…
High riskUsing this product could cause serious injury, illness or death — stop using it now.ICU Medical, Inc.
FDA (openFDA device enforcement)
Reported Oct 29, 2025
Artegraft¿ Collagen Vascular Graft; REF: AG1015;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LeMaitre Vascular, Inc.
FDA (openFDA device enforcement)
Reported Oct 29, 2025
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries, LP
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.