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 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)
Reported May 20, 2026
LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microvention Inc.
FDA (openFDA device enforcement)
Reported May 20, 2026
Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Omnicell, Inc.
FDA (openFDA device enforcement)
Reported May 20, 2026
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Moderate riskThis product could cause temporary or reversible health problems — stop using it.On-X Life Technologies, Inc.
FDA (openFDA device enforcement)
Reported May 20, 2026
Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
FDA (openFDA device enforcement)
Reported May 20, 2026
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Quidel Corporation
FDA (openFDA device enforcement)
Reported May 20, 2026
Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
FDA (openFDA device enforcement)
Reported May 20, 2026
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
25 more products in this recall
FDA (openFDA device enforcement)
Reported May 20, 2026
Diowave Laser System, REF: Diowave 250W
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Technological Medical Advancements LLC
FDA (openFDA device enforcement)
Reported May 20, 2026
Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Windstone Medical Packaging, Inc.
FDA (openFDA device enforcement)
Reported May 13, 2026
Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model…
High riskUsing this product could cause serious injury, illness or death — stop using it now.American Contract Systems Inc.
FDA (openFDA device enforcement)
Reported May 13, 2026
Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.
High riskUsing this product could cause serious injury, illness or death — stop using it now.AVID Medical, Inc.
9 more products in this recall
FDA (openFDA device enforcement)
Reported May 13, 2026
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
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 May 13, 2026
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
1 more product 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.