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 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)
Reported Jun 18, 2025
EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Quantum Surgical Sas
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remel, Inc.
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker GmbH
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version: No…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tecfen Medical
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Turncare, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Zyno Medical LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 11, 2025
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Mishima K.K.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 11, 2025
Access Testosterone assay, Catalog Number 33560
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 Jun 11, 2025
BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Civco Medical Instruments Co. Inc.
FDA (openFDA device enforcement)
Reported Jun 11, 2025
Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dexcom, Inc.
FDA (openFDA device enforcement)
Reported Jun 11, 2025
Lazervida 10W diode laser cutter and engraver with Lazervida shield.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Flux Technology Inc.
FDA (openFDA device enforcement)
Reported Jun 11, 2025
FoundationOne Companion Diagnostic (F1CDx)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Foundation Medicine, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 11, 2025
Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Healthmark Industries Co., Inc.
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.