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.
13,791 stored notices, reported between Jun 20, 2012 and Oct 28, 2026. Newest first.
Reported Jun 3, 2026
HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Devicor Medical Products Inc.
FDA (openFDA device enforcement)
Reported Jun 3, 2026
GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems Information Technologies Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 3, 2026
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) ANESTHESIA TRAY, Medline…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medline Industries, LP
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 3, 2026
Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 3, 2026
Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.O&m Halyard Inc.
FDA (openFDA device enforcement)
Reported Jun 3, 2026
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064,…
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 May 27, 2026
Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton, Dickinson and Company
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 27, 2026
Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.C.R. Bard Inc.
FDA (openFDA device enforcement)
Reported May 27, 2026
Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
FDA (openFDA device enforcement)
Reported May 27, 2026
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
8 more products in this recall
FDA (openFDA device enforcement)
Reported May 27, 2026
OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7 Degree 10mm X…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Novapproach Spine, LLC
FDA (openFDA device enforcement)
Reported May 27, 2026
Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 27, 2026
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tangent Endoscopy, LLC
FDA (openFDA device enforcement)
Reported May 20, 2026
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aniara Diagnostica LLC
FDA (openFDA device enforcement)
Reported May 20, 2026
Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
High riskUsing this product could cause serious injury, illness or death — stop using it now.Arrow International, LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 20, 2026
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dexcom, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 20, 2026
Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Djo, LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 20, 2026
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Edwards Lifesciences, LLC
FDA (openFDA device enforcement)
Reported May 20, 2026
Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
6 more products in this recall
FDA (openFDA device enforcement)
Reported May 20, 2026
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hologic, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 20, 2026
Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp. (NeuroSciences)
FDA (openFDA device enforcement)
Reported May 20, 2026
LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Jolife AB
FDA (openFDA device enforcement)
Reported May 20, 2026
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medline Industries, LP
10 more products in this recall
FDA (openFDA device enforcement)
Reported May 20, 2026
Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
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.