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 Nov 23, 2022
Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Getinge USA Sales Inc.
FDA (openFDA device enforcement)
Reported Nov 23, 2022
Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
FDA (openFDA device enforcement)
Reported Nov 23, 2022
18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Insulet Corporation
FDA (openFDA device enforcement)
Reported Nov 23, 2022
TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LeMaitre Vascular, Inc.
FDA (openFDA device enforcement)
Reported Nov 23, 2022
Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
FDA (openFDA device enforcement)
Reported Nov 23, 2022
OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Novapproach Spine LLC
FDA (openFDA device enforcement)
Reported Nov 23, 2022
GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sonendo Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 23, 2022
Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spectranetics Corporation
FDA (openFDA device enforcement)
Reported Nov 23, 2022
GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
FDA (openFDA device enforcement)
Reported Nov 23, 2022
Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex LLC
FDA (openFDA device enforcement)
Reported Nov 23, 2022
Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Texas Medical Technology Inc.
FDA (openFDA device enforcement)
Reported Nov 23, 2022
Infection Control (IC) Lifting Strap used with the following Cirrus and Pinnacle Ceiling Lifts: Cirrus 450, Cirrus 600,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tollos
FDA (openFDA device enforcement)
Reported Nov 16, 2022
Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Access Vascular, Inc.
FDA (openFDA device enforcement)
Reported Nov 16, 2022
Disc Preparation instruments contained in the following products: CI-11050-08102515 Longer IdentiTi PO Trial Tip, 11A X…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alphatec Spine, Inc.
FDA (openFDA device enforcement)
Reported Nov 16, 2022
Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Avanos Medical, Inc.
FDA (openFDA device enforcement)
Reported Nov 16, 2022
Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may be used in various types of orthopedic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beaver Visitec International, Inc.
FDA (openFDA device enforcement)
Reported Nov 16, 2022
ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of…
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 Nov 16, 2022
Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Canon Medical System, USA, Inc.
FDA (openFDA device enforcement)
Reported Nov 16, 2022
Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
7 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 16, 2022
NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperSurgical, Inc.
FDA (openFDA device enforcement)
Reported Nov 16, 2022
FERNO POWER X1 AMBULANCE COT- Item #0015807/UDI-DI 00190790002183 with 36V Li-Ion Batteries Model Number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ferno-Washington Inc.
FDA (openFDA device enforcement)
Reported Nov 16, 2022
NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
FDA (openFDA device enforcement)
Reported Nov 16, 2022
Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.iRhythm Technologies, Inc.
FDA (openFDA device enforcement)
Reported Nov 16, 2022
Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 670G/ MMT-1780, MMT-1781, MMT-1782, MMT-1760,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed
1 more product 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.