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 Dec 20, 2023
TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Dec 20, 2023
VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 20, 2023
Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR)…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Philips North America LLC
FDA (openFDA device enforcement)
Reported Dec 20, 2023
Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Riverpoint Medical, LLC
FDA (openFDA device enforcement)
Reported Dec 20, 2023
ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Dec 20, 2023
Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spectranetics Corporation
FDA (openFDA device enforcement)
Reported Dec 13, 2023
Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abiomed, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 13, 2023
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 13, 2023
Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Auris Health Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 13, 2023
Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15…
High riskUsing this product could cause serious injury, illness or death — stop using it now.B. Braun Medical, Inc.
FDA (openFDA device enforcement)
Reported Dec 13, 2023
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioFire Diagnostics, LLC
FDA (openFDA device enforcement)
Reported Dec 13, 2023
CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CardioQuip, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 13, 2023
DRX Revolution Mobile X-Ray System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carestream Health, Inc.
FDA (openFDA device enforcement)
Reported Dec 13, 2023
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperSurgical, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 13, 2023
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Elekta, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 13, 2023
DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Encore Medical, LP
FDA (openFDA device enforcement)
Reported Dec 13, 2023
Stay Safe Cap
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
FDA (openFDA device enforcement)
Reported Dec 13, 2023
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Heartware, Inc.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 13, 2023
Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with built in 42A Lightweight Spring Arm…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ihb Operations B.v.
FDA (openFDA device enforcement)
Reported Dec 13, 2023
Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 13, 2023
Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Liberty Medical Solutions, LLC
FDA (openFDA device enforcement)
Reported Dec 13, 2023
Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Luminex Corporation
FDA (openFDA device enforcement)
Reported Dec 13, 2023
CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Maquet Medical Systems USA
FDA (openFDA device enforcement)
Reported Dec 13, 2023
VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
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.