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
5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aniara Diagnostica LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK…
High riskUsing this product could cause serious injury, illness or death — stop using it now.AVID Medical, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2026
REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Biomedical GmbH
FDA (openFDA device enforcement)
Reported Aug 12, 2026
REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: -…
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 Aug 12, 2026
FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biofire Defense
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2026
INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Neuromodulation Corporation
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Contego Medical, Inc.
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version: WebApp version 2.33.1, 2.33.3…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Copan WASP
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Freudenberg Medical, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2026
GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems Information Technologies Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Happiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S1000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Happiest Baby, Inc.
FDA (openFDA device enforcement)
Reported Aug 12, 2026
HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hardy Diagnostics
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Innovasis, Inc.
FDA (openFDA device enforcement)
Reported Aug 12, 2026
GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2026
FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-piece…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integrated Medcraft LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i C30 6888530…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Critical Care AB
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medical Action Industries, Inc. 306
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Merge PACS, medical imaging diagnostic workstation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2026
munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Munevo GmbH
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nuclein LLC
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog Number: MC2, MC2.1 Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Oxos Medical Inc.
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model…
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)
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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.