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 12, 2022
UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Uromedica Inc.
FDA (openFDA device enforcement)
Reported Jan 5, 2022
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott
FDA (openFDA device enforcement)
Reported Jan 5, 2022
iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States);…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AMO Manufacturing USA, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 5, 2022
RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomerieux Inc.
FDA (openFDA device enforcement)
Reported Jan 5, 2022
VIDAS PRG Progesterone, REF 30409-01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
15 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 5, 2022
Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube charging…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Forbes Rehab Services Inc.
FDA (openFDA device enforcement)
Reported Jan 5, 2022
da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
FDA (openFDA device enforcement)
Reported Jan 5, 2022
Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
FDA (openFDA device enforcement)
Reported Jan 5, 2022
Model B35200 - Percept PC BrainSense Implantable Neurostimulator
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported Jan 5, 2022
FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Migo Trading LLC
FDA (openFDA device enforcement)
Reported Jan 5, 2022
Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Jan 5, 2022
ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Dec 29, 2021
TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Acclarent, Inc.
FDA (openFDA device enforcement)
Reported Dec 29, 2021
Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beaver Visitec International, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 29, 2021
SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
FDA (openFDA device enforcement)
Reported Dec 29, 2021
WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cardiovascular Systems Inc.
FDA (openFDA device enforcement)
Reported Dec 29, 2021
VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Civco Medical Instruments Co. Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 29, 2021
Torosa Saline-Filled Testicular Prosthesis (Size Small)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Coloplast Manufacturing US, LLC
FDA (openFDA device enforcement)
Reported Dec 29, 2021
Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
FDA (openFDA device enforcement)
Reported Dec 29, 2021
These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hill-Rom Inc.
FDA (openFDA device enforcement)
Reported Dec 29, 2021
Leica Microsystems M220 F12 Microscope Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Leica Microsystems, Inc.
FDA (openFDA device enforcement)
Reported Dec 29, 2021
Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
FDA (openFDA device enforcement)
Reported Dec 29, 2021
Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
FDA (openFDA device enforcement)
Reported Dec 29, 2021
Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Navigation, Inc.
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.