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 Sep 10, 2025
Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp. (NeuroSciences)
7 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 10, 2025
Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Lumicell, Inc.
FDA (openFDA device enforcement)
Reported Sep 10, 2025
Medshape Universal Joints, REF: DNE-9000-UJ
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medshape, Inc.
FDA (openFDA device enforcement)
Reported Sep 10, 2025
InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
FDA (openFDA device enforcement)
Reported Sep 10, 2025
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Perfusion Systems
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 10, 2025
Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
FDA (openFDA device enforcement)
Reported Sep 10, 2025
Micro Joystick R-net. Electrical wheelchair component.
High riskUsing this product could cause serious injury, illness or death — stop using it now.mo-Vis BVBA
5 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 10, 2025
Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
Moderate riskThis product could cause temporary or reversible health problems — stop using it.O&m Halyard Inc.
FDA (openFDA device enforcement)
Reported Sep 10, 2025
Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 10, 2025
LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Physio-Control, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 10, 2025
NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Preat Corp.
FDA (openFDA device enforcement)
Reported Sep 10, 2025
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Premia Spine Ltd.
FDA (openFDA device enforcement)
Reported Sep 10, 2025
RayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19. 2. RayStation 8A,…
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 Sep 10, 2025
RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Reflexion Medical, Inc.
FDA (openFDA device enforcement)
Reported Sep 10, 2025
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Visgeneer, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 3, 2025
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems Inc.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 3, 2025
Akreos, SKU: AO60P0300. Akreos intraocular lenses
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Bausch & Lomb Surgical, Inc.
FDA (openFDA device enforcement)
Reported Sep 3, 2025
Spectrum IQ Infusion Pump, Product Code 3570009
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 3, 2025
BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bd Switzerland Sarl
FDA (openFDA device enforcement)
Reported Sep 3, 2025
Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.C.R. Bard Inc.
FDA (openFDA device enforcement)
Reported Sep 3, 2025
BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis"…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
FDA (openFDA device enforcement)
Reported Sep 3, 2025
Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dentsply IH, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 3, 2025
STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Diagnostica Stago, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 3, 2025
GE HealthCare OEC 9800.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
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.