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 Feb 19, 2025
The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ithera Medical GmbH
FDA (openFDA device enforcement)
Reported Feb 19, 2025
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Max Mobility LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 19, 2025
Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microbiologics Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 19, 2025
MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microvention Inc.
FDA (openFDA device enforcement)
Reported Feb 19, 2025
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Murata Vios, Inc.
FDA (openFDA device enforcement)
Reported Feb 19, 2025
Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Feb 19, 2025
stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 12, 2025
Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
FDA (openFDA device enforcement)
Reported Feb 12, 2025
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Feb 12, 2025
Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Belmont Instrument LLC
FDA (openFDA device enforcement)
Reported Feb 12, 2025
Temporary Titanium Abutments
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DDS Lab
FDA (openFDA device enforcement)
Reported Feb 12, 2025
PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 12, 2025
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
FDA (openFDA device enforcement)
Reported Feb 12, 2025
Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 12, 2025
The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hologic, Inc.
FDA (openFDA device enforcement)
Reported Feb 12, 2025
SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LivaNova USA, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 12, 2025
UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medicrea International
FDA (openFDA device enforcement)
Reported Feb 12, 2025
NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Neilmed Pharmaceuticals Inc.
FDA (openFDA device enforcement)
Reported Feb 12, 2025
Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.New Medical Technologies GmbH
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 12, 2025
. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nobel Biocare
FDA (openFDA device enforcement)
Reported Feb 12, 2025
Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Oxoid Limited
FDA (openFDA device enforcement)
Reported Feb 12, 2025
Allura CV20 System Code: 722031
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
18 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 12, 2025
IntelliBridge EC10 Module. Model Number: 865115
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
4 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 12, 2025
LIFEPAK 35 ECG cable REF 11111-000041
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Physio-Control, 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.