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 Apr 26, 2023
BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall A…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
FDA (openFDA device enforcement)
Reported Apr 26, 2023
FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioFire Diagnostics, LLC
FDA (openFDA device enforcement)
Reported Apr 26, 2023
Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
FDA (openFDA device enforcement)
Reported Apr 26, 2023
REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Compass Health Brands (Corporate Office)
FDA (openFDA device enforcement)
Reported Apr 26, 2023
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Covidien
FDA (openFDA device enforcement)
Reported Apr 26, 2023
GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Gramercy Extremity Orthopedics
FDA (openFDA device enforcement)
Reported Apr 26, 2023
MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medacta USA Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 26, 2023
Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
FDA (openFDA device enforcement)
Reported Apr 26, 2023
Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported Apr 26, 2023
INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 26, 2023
Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.NeuroLogica Corporation
FDA (openFDA device enforcement)
Reported Apr 26, 2023
Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Apr 26, 2023
VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Apr 26, 2023
SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 26, 2023
KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pro-Dex Inc.
FDA (openFDA device enforcement)
Reported Apr 26, 2023
AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Radiometer Medical ApS
FDA (openFDA device enforcement)
Reported Apr 26, 2023
JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
FDA (openFDA device enforcement)
Reported Apr 26, 2023
Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tobii Dynavox LLC
FDA (openFDA device enforcement)
Reported Apr 19, 2023
Agilent Resolution ctDx FIRST Sample Collection Kit, 500032
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Agilent Technologies Inc./us
FDA (openFDA device enforcement)
Reported Apr 19, 2023
NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
FDA (openFDA device enforcement)
Reported Apr 19, 2023
BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bio-Rad Laboratories, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 19, 2023
Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Church & Dwight Inc.
FDA (openFDA device enforcement)
Reported Apr 19, 2023
Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Coloplast Manufacturing US, LLC
16 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 19, 2023
Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number…
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)
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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.