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 Jul 24, 2024
OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
28 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 24, 2024
Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara.…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 24, 2024
BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton, Dickinson and Company, BD Biosciences
FDA (openFDA device enforcement)
Reported Jul 24, 2024
Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
FDA (openFDA device enforcement)
Reported Jul 24, 2024
Cascade IOMAX Cortical Module, REF: 190296-200
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cadwell Industries Inc.
FDA (openFDA device enforcement)
Reported Jul 24, 2024
Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Canadian Hospital Specialties Ltd.
FDA (openFDA device enforcement)
Reported Jul 24, 2024
BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
FDA (openFDA device enforcement)
Reported Jul 24, 2024
SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon Sarl, a Johnson & Johnson Company
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 24, 2024
VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Greiner Bio-One North America, Inc.
FDA (openFDA device enforcement)
Reported Jul 24, 2024
Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hologic Inc.
FDA (openFDA device enforcement)
Reported Jul 24, 2024
UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 24, 2024
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MED-EL Elektromedizinische Gereate, GmbH
FDA (openFDA device enforcement)
Reported Jul 24, 2024
Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medical Depot Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 24, 2024
Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported Jul 24, 2024
QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Qiagen Sciences LLC
FDA (openFDA device enforcement)
Reported Jul 24, 2024
Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Seaspine Orthopedics Corporation
FDA (openFDA device enforcement)
Reported Jul 24, 2024
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
Moderate riskThis product could cause temporary or reversible health problems — stop using it.St. Jude Medical
FDA (openFDA device enforcement)
Reported Jul 24, 2024
REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
FDA (openFDA device enforcement)
Reported Jul 24, 2024
Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Waldemar Link GmbH & Co. KG (Mfg Site)
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 17, 2024
AHAR50K STANDARD ARTHROSCOPY PACK - 291852. Procedure tray Catalog Number: AHAR50K
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems Inc.
38 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 17, 2024
MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Barco N.V.
FDA (openFDA device enforcement)
Reported Jul 17, 2024
VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 17, 2024
Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2) ANGIOGRAPHY PACK, Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 17, 2024
Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Echonous 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.