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 21, 2021
Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA (openFDA device enforcement)
Reported Jul 21, 2021
Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mercedes Medical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 21, 2021
Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Owen Mumford USA, Inc.
FDA (openFDA device enforcement)
Reported Jul 21, 2021
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Philips Respironics, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 21, 2021
Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RanD S.r.l.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 21, 2021
Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tornier, Inc.
FDA (openFDA device enforcement)
Reported Jul 14, 2021
FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioFire Diagnostics, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 14, 2021
Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 14, 2021
Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - Product Usage: intended to be used as…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 14, 2021
Revolution CT
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 14, 2021
HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Liebel-Flarsheim Company LLC
FDA (openFDA device enforcement)
Reported Jul 14, 2021
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Luminex Corporation
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 14, 2021
CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Heart Valves Division
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 14, 2021
Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Randox Laboratories Ltd.
FDA (openFDA device enforcement)
Reported Jul 14, 2021
ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Sentinel CH SpA
FDA (openFDA device enforcement)
Reported Jul 14, 2021
The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 14, 2021
ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Jul 14, 2021
FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Binding Site Group, Ltd.
FDA (openFDA device enforcement)
Reported Jul 14, 2021
Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Vivorte, Inc.
FDA (openFDA device enforcement)
Reported Jul 7, 2021
5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bard Access Systems Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 7, 2021
MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carefusion
FDA (openFDA device enforcement)
Reported Jul 7, 2021
Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Edwards Lifesciences, LLC
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 7, 2021
Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
FDA (openFDA device enforcement)
Reported Jul 7, 2021
Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra Programmable…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Flowonix Medical 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.