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 Nov 2, 2022
ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Nov 2, 2022
GORE CARDIOFORM ASD Occluder. cardiovascular implant.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.W L Gore & Associates, Inc.
FDA (openFDA device enforcement)
Reported Nov 2, 2022
Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 2, 2022
AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ZOLL Circulation, Inc.
FDA (openFDA device enforcement)
Reported Oct 26, 2022
Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT US/CDS0701-NT,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Vascular
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 26, 2022
ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ARROW INTERNATIONAL Inc.
FDA (openFDA device enforcement)
Reported Oct 26, 2022
ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 26, 2022
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Balt USA, LLC
FDA (openFDA device enforcement)
Reported Oct 26, 2022
BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001. For collecting,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
FDA (openFDA device enforcement)
Reported Oct 26, 2022
Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intersurgical Inc.
FDA (openFDA device enforcement)
Reported Oct 26, 2022
Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medicina Uk Ltd.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 26, 2022
CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
FDA (openFDA device enforcement)
Reported Oct 26, 2022
cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Molecular Systems, Inc.
FDA (openFDA device enforcement)
Reported Oct 26, 2022
N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297
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 26, 2022
Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN):…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 26, 2022
SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 26, 2022
Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Teleflex LLC
5 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 19, 2022
COVID Test Kit Nonsterile
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems, Inc.
FDA (openFDA device enforcement)
Reported Oct 19, 2022
Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
4 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 19, 2022
Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hobbs Medical, Inc.
60 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 19, 2022
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
High riskUsing this product could cause serious injury, illness or death — stop using it now.Jiangsu Well Biotech Co.,Ltd.
FDA (openFDA device enforcement)
Reported Oct 19, 2022
Veritas Advanced Infusion Packs. Used in ophthalmic procedures.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Johnson & Johnson Surgical Vision, Inc.
FDA (openFDA device enforcement)
Reported Oct 19, 2022
Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LUMINOSTICS, Inc. dba CLIP HEALTH
FDA (openFDA device enforcement)
Reported Oct 19, 2022
VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
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.