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 Jun 25, 2025
UROSKOP Omnia. Model Number: 10094910
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 25, 2025
Lago X
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spectral Instruments Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 18, 2025
LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems, Inc.
FDA (openFDA device enforcement)
Reported Jun 18, 2025
2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600
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 Jun 18, 2025
Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bd Switzerland Sarl
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 18, 2025
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Allon 2001. Part Number: 200-00263
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Belmont Instrument LLC
FDA (openFDA device enforcement)
Reported Jun 18, 2025
SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Contamac Solutions, Inc.
FDA (openFDA device enforcement)
Reported Jun 18, 2025
BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Copan Italia
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Covidien
FDA (openFDA device enforcement)
Reported Jun 18, 2025
IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL.…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
FDA (openFDA device enforcement)
Reported Jun 18, 2025
MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems Information Technologies Inc.
FDA (openFDA device enforcement)
Reported Jun 18, 2025
OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient…
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)
Reported Jun 18, 2025
Azure S DR MRI SureScan, Product number W3DR01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic, Inc.
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MicroAire Surgical Instruments, LLC
FDA (openFDA device enforcement)
Reported Jun 18, 2025
KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microbiologics Inc.
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microtek Medical, Inc.
FDA (openFDA device enforcement)
Reported Jun 18, 2025
iBOT PMD with software version 01.05.24. Personal Mobility Device.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mobius Mobility LLC
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Natus Neurology dba Excel Tech., Ltd. (XLTEK)
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Achieva XR Product Numbers: (1) 781153, (2) 781253;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
8 more products 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.