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 Oct 27, 2021
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho Clinical Diagnostics Inc.
FDA (openFDA device enforcement)
Reported Oct 27, 2021
EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Ultrasound Inc.
FDA (openFDA device enforcement)
Reported Oct 27, 2021
Atellica IM 1300 Analyzer, SMN 11066001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 27, 2021
6.5MMX165MM CANNULATED SCREW
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
FDA (openFDA device enforcement)
Reported Oct 27, 2021
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d.…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 27, 2021
Tenaculum, Plastic
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stradis Medical, LLC dba Stradis Healthcare
5 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 20, 2021
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abbott Molecular, Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 20, 2021
Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
FDA (openFDA device enforcement)
Reported Oct 20, 2021
BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bio-Rad Laboratories, Inc.
FDA (openFDA device enforcement)
Reported Oct 20, 2021
MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioMerieux SA
FDA (openFDA device enforcement)
Reported Oct 20, 2021
Thoraguard Chest Tube Kit, 20 Fr
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Centese Inc.
FDA (openFDA device enforcement)
Reported Oct 20, 2021
Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Draeger Medical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 20, 2021
Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Elekta Solutions Ab
FDA (openFDA device enforcement)
Reported Oct 20, 2021
Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekta…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Elekta, Inc.
FDA (openFDA device enforcement)
Reported Oct 20, 2021
Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Flower Orthopedics Corporation
3 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 20, 2021
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Inpeco S.A.
FDA (openFDA device enforcement)
Reported Oct 20, 2021
Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
FDA (openFDA device enforcement)
Reported Oct 20, 2021
Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
Moderate riskThis product could cause temporary or reversible health problems — stop using it.K2M, Inc.
FDA (openFDA device enforcement)
Reported Oct 20, 2021
Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 20, 2021
ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs ECO 40JMC Gel…
High riskUsing this product could cause serious injury, illness or death — stop using it now.National Distribution & Contracting Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 20, 2021
Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 20, 2021
EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU
High riskUsing this product could cause serious injury, illness or death — stop using it now.Red Medical Supplies
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 20, 2021
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Molecular Systems, Inc.
FDA (openFDA device enforcement)
Reported Oct 20, 2021
medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
11 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.