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 Jan 22, 2025
Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ev3 Inc.
FDA (openFDA device enforcement)
Reported Jan 22, 2025
GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ge Medical Systems Israel, Functional Imaging
12 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hologic, Inc.
FDA (openFDA device enforcement)
Reported Jan 22, 2025
8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
38 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.IsoTis OrthoBiologics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069; 2)…
High riskUsing this product could cause serious injury, illness or death — stop using it now.MEDLINE INDUSTRIES, LP - Northfield
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Mercury Enterprises, Inc. dba Mercury Medical
FDA (openFDA device enforcement)
Reported Jan 22, 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 Jan 22, 2025
NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX
Moderate riskThis product could cause temporary or reversible health problems — stop using it.NOA Medical Industries Inc.
FDA (openFDA device enforcement)
Reported Jan 22, 2025
nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Nuwellis Inc.
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Olympus Corporation of the Americas
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Quidel Ortho
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sin Sistema de Implante Nacional S.a
FDA (openFDA device enforcement)
Reported Jan 22, 2025
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" BUCK EAR CUR BL STR#0STRLCS/25, Model Number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sklar Instruments
29 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tornier S.A.S.
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Trokamed GmbH
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 15, 2025
Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.3B Medical, Inc.
FDA (openFDA device enforcement)
Reported Jan 15, 2025
Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aerin Medical, Inc.
FDA (openFDA device enforcement)
Reported Jan 15, 2025
AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Applied Medical Technology Inc.
FDA (openFDA device enforcement)
Reported Jan 15, 2025
Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Jan 15, 2025
EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Elucent Medical Inc.
FDA (openFDA device enforcement)
Reported Jan 15, 2025
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
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.