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 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)
Reported May 13, 2026
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Centinel Spine, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 13, 2026
Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cook Incorporated
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 13, 2026
One Step 10A in vitro diagnostic test
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DFI Co., Ltd.
6 more products in this recall
FDA (openFDA device enforcement)
Reported May 13, 2026
ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Erbe Medical, LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 13, 2026
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
High riskUsing this product could cause serious injury, illness or death — stop using it now.Intuitive Surgical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 13, 2026
DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Katalyst Surgical, LLC
11 more products in this recall
FDA (openFDA device enforcement)
Reported May 13, 2026
Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medical Action Industries, Inc. 306
FDA (openFDA device enforcement)
Reported May 13, 2026
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries, LP
41 more products in this recall
FDA (openFDA device enforcement)
Reported May 13, 2026
Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mint Medical GmbH
FDA (openFDA device enforcement)
Reported May 13, 2026
BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Orthorebirth Co. Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 13, 2026
LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Physio-Control, 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.