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 15, 2023
Novum IQ Syringe infusion system, Product Code 40800BAXUS
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Nov 15, 2023
BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Breg Inc.
FDA (openFDA device enforcement)
Reported Nov 15, 2023
BD Alaris PCU REF 8015
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 303, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 15, 2023
The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carestream Health, Inc.
FDA (openFDA device enforcement)
Reported Nov 15, 2023
Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Change Healthcare Canada Company
FDA (openFDA device enforcement)
Reported Nov 15, 2023
Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cordis US Corp.
FDA (openFDA device enforcement)
Reported Nov 15, 2023
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Edwards Lifesciences, LLC
FDA (openFDA device enforcement)
Reported Nov 15, 2023
DJO EMPOWR Knee Punch Handle, REF: 801-05-040
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Encore Medical, LP
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 15, 2023
CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Family Dollar Stores, Llc.
9 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 15, 2023
LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Magellan Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Nov 15, 2023
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Medical Systems USA
FDA (openFDA device enforcement)
Reported Nov 15, 2023
StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Navigation, Inc.
FDA (openFDA device enforcement)
Reported Nov 15, 2023
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Olympus Corporation of the Americas
6 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 15, 2023
VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Nov 15, 2023
Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Percussionaire Corporation
FDA (openFDA device enforcement)
Reported Nov 15, 2023
CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
9 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 15, 2023
BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
5 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 15, 2023
Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model #…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Ultrasound, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 15, 2023
Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pulmonx, Corp.
FDA (openFDA device enforcement)
Reported Nov 15, 2023
Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Securitas Healthcare LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 15, 2023
CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.St. Jude Medical
FDA (openFDA device enforcement)
Reported Nov 15, 2023
Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-180-005
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
19 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 15, 2023
CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Young Dental Manufacturing I, LLC
FDA (openFDA device enforcement)
Reported Nov 8, 2023
Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott
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.