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.
13,791 stored notices, reported between Jun 20, 2012 and Oct 28, 2026. Newest first.
Reported Jan 22, 2025
Impella RP with SmartAssist; Product Number: 0046-0035;
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Accriva Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model #…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Augustine Temperature Management, LLC
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biocartis Nv
FDA (openFDA device enforcement)
Reported Jan 22, 2025
ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
9 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Coloplast Manufacturing US, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ConvaTec, Inc.
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Biotech, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DRG International, Inc.
FDA (openFDA device enforcement)
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)
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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.