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 Jun 30, 2021
GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
High riskUsing this product could cause serious injury, illness or death — stop using it now.Vero Biotech, LLC
FDA (openFDA device enforcement)
Reported Jun 23, 2021
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories Inc. (St Jude Medical)
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 23, 2021
Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Anodyne Surgical
FDA (openFDA device enforcement)
Reported Jun 23, 2021
VENOVO Venous Stent System 10F Product Description(REF)/dimension: VENEL16040 Venovo 10F 16/40/1200mm OUS VENEL16060…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bard Peripheral Vascular Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 23, 2021
The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Circulatory Technology Inc.
FDA (openFDA device enforcement)
Reported Jun 23, 2021
Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Corin Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 23, 2021
Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien, LP
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 23, 2021
GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
FDA (openFDA device enforcement)
Reported Jun 23, 2021
ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive Power -1.50
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Johnson & Johnson Vision Care, Inc.
FDA (openFDA device enforcement)
Reported Jun 23, 2021
Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medivators, Inc.
FDA (openFDA device enforcement)
Reported Jun 23, 2021
Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
24 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 23, 2021
Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Vascular
FDA (openFDA device enforcement)
Reported Jun 23, 2021
OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ossur Americas
FDA (openFDA device enforcement)
Reported Jun 23, 2021
Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Radiometer Medical ApS
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 23, 2021
Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Jun 23, 2021
Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Skytron, Div. The KMW Group, Inc.
FDA (openFDA device enforcement)
Reported Jun 23, 2021
Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire 80 oz 4 Clamp Towel 2.5 1 Cover…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Windstone Medical Packaging, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alphatec Spine, Inc.
28 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 16, 2021
ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-04
High riskUsing this product could cause serious injury, illness or death — stop using it now.Avid Medical, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 16, 2021
ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Brainlab AG
FDA (openFDA device enforcement)
Reported Jun 16, 2021
CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodes,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperSurgical, Inc.
FDA (openFDA device enforcement)
Reported Jun 16, 2021
DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
FDA (openFDA device enforcement)
Reported Jun 16, 2021
DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06
High riskUsing this product could cause serious injury, illness or death — stop using it now.DeRoyal Industries Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 16, 2021
Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hardy Diagnostics
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.