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 Jan 17, 2024
Sensis Vibe Hemo
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Jan 17, 2024
SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SoClean, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 17, 2024
CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Townsend Design
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 10, 2024
Impella Connect, software portal for online device management that allows clinicians and Impella support staff to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abiomed, Inc.
FDA (openFDA device enforcement)
Reported Jan 10, 2024
Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beaver Visitec International, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 10, 2024
Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
High riskUsing this product could cause serious injury, illness or death — stop using it now.Busse Hospital Disposables, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 10, 2024
Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien
FDA (openFDA device enforcement)
Reported Jan 10, 2024
Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Encore Medical, LP
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 10, 2024
Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Insulet Corporation
FDA (openFDA device enforcement)
Reported Jan 10, 2024
KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Keystone Industries
FDA (openFDA device enforcement)
Reported Jan 10, 2024
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
FDA (openFDA device enforcement)
Reported Jan 10, 2024
Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 10, 2024
External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Natus Medical Incorporated
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 10, 2024
Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Respironics, Inc.
FDA (openFDA device enforcement)
Reported Jan 10, 2024
SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Randox Laboratories Ltd.
FDA (openFDA device enforcement)
Reported Jan 10, 2024
Regard Dressing change kit, Item Number 800026006
High riskUsing this product could cause serious injury, illness or death — stop using it now.ROi CPS LLC
FDA (openFDA device enforcement)
Reported Jan 10, 2024
Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet Spine Inc.
FDA (openFDA device enforcement)
Reported Jan 3, 2024
Alinity ci-series System Control Module, REF: 03R70-01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
FDA (openFDA device enforcement)
Reported Jan 3, 2024
RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Acumed LLC
FDA (openFDA device enforcement)
Reported Jan 3, 2024
Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ARJOHUNTLEIGH POLSKA Sp. z.o.o.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 3, 2024
Atrium Oasis Drain Single W / AC, Part No. 3600-100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
FDA (openFDA device enforcement)
Reported Jan 3, 2024
DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DeRoyal Industries Inc.
FDA (openFDA device enforcement)
Reported Jan 3, 2024
Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Fresenius Medical Care Holdings, Inc.
FDA (openFDA device enforcement)
Reported Jan 3, 2024
Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Landauer
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.