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 Aug 12, 2026
Brand Name: Quantum Rehab Product Name: Quantum 4Front 2 Model/Catalog Number: Quantum 4Front 2 Software Version:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pride Mobility Products Corp.
12 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Siemens Healthcare Diagnostics, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2026
STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
4 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Therabody, Inc.
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Theranica Bioelectronics Ltd.
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number: NCOCO1510 Software Version: N/A…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tissium Sa
7 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.United Orthopedic Corp.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 5, 2026
L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539; 18ga (3.5F) 1.15mm x…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Argon Medical Devices, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 5, 2026
GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory
5 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 5, 2026
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
Moderate riskThis product could cause temporary or reversible health problems — stop using it.IsoTis OrthoBiologics, Inc.
FDA (openFDA device enforcement)
Reported Aug 5, 2026
Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic Star Off Handle Manifolds
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medical Action Industries, Inc. 306
FDA (openFDA device enforcement)
Reported Aug 5, 2026
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
5 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 5, 2026
Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock REF:120031, Model version 3
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Permobil Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 5, 2026
Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades
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 Aug 5, 2026
Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory…
High riskUsing this product could cause serious injury, illness or death — stop using it now.ResMed Ltd.
FDA (openFDA device enforcement)
Reported Aug 5, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker GmbH
6 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 5, 2026
Power Over Fiber Base Module
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terex Utilities
FDA (openFDA device enforcement)
Reported Aug 5, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part Number AMS10411B; 2) ENT Pack,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Windstone Medical Packaging, Inc.
11 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 29, 2026
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alphatec Spine, Inc.
FDA (openFDA device enforcement)
Reported Jul 29, 2026
Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AVID Medical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 29, 2026
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
8 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 29, 2026
Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Emano Metrics, Inc.
FDA (openFDA device enforcement)
Reported Jul 29, 2026
Power F2 Powered Fastening System, Product No. 0567091 Powered fastening system intended for professional use only.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ferno-Washington Inc.
FDA (openFDA device enforcement)
Reported Jul 29, 2026
Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical 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.