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 12, 2025
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to…
High riskUsing this product could cause serious injury, illness or death — stop using it now.ROi CPS LLC
FDA (openFDA device enforcement)
Reported Feb 12, 2025
Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sysmex America, Inc.
FDA (openFDA device enforcement)
Reported Feb 12, 2025
Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP125253PK…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.US Endodontics, LLC
FDA (openFDA device enforcement)
Reported Feb 5, 2025
CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Accuray Incorporated
FDA (openFDA device enforcement)
Reported Feb 5, 2025
Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alphatec Spine, Inc.
FDA (openFDA device enforcement)
Reported Feb 5, 2025
Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
FDA (openFDA device enforcement)
Reported Feb 5, 2025
AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
13 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 5, 2025
BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
FDA (openFDA device enforcement)
Reported Feb 5, 2025
Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Draeger Medical Systems, Inc.
FDA (openFDA device enforcement)
Reported Feb 5, 2025
HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory
FDA (openFDA device enforcement)
Reported Feb 5, 2025
KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
13 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 5, 2025
Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA…
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 5, 2025
Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B; 2) ARTERIAL LINE BUNDLE, Item…
High riskUsing this product could cause serious injury, illness or death — stop using it now.MEDLINE INDUSTRIES, LP - Northfield
6 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 5, 2025
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
FDA (openFDA device enforcement)
Reported Feb 5, 2025
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Murata Vios, Inc.
FDA (openFDA device enforcement)
Reported Feb 5, 2025
ARTIS One Angiographic X-Ray System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Feb 5, 2025
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 29, 2025
Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Adept Medical Ltd.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 29, 2025
Baxter Solution Set with Duo-Vent Spike, REF 2R8404
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 29, 2025
BD PCR Cartridges used with MAX System. Model Number: 437519
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
FDA (openFDA device enforcement)
Reported Jan 29, 2025
BD Pyxis MedStation ES (Med ES Main), REF 323
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 29, 2025
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 29, 2025
Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integrity Implants Inc.
FDA (openFDA device enforcement)
Reported Jan 29, 2025
Bodor P and C series laser cutting machines
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Jinan Bodor Cnc Machine Co. Ltd.
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.