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 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)
Reported Jan 3, 2024
Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.MEDLINE INDUSTRIES, LP - Northfield
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 3, 2024
Medtronic SynchroMed II, Model 8637-20, Programmable pump
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 Jan 3, 2024
Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode
High riskUsing this product could cause serious injury, illness or death — stop using it now.Megadyne Medical Products, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 3, 2024
Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
FDA (openFDA device enforcement)
Reported Dec 27, 2023
Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
FDA (openFDA device enforcement)
Reported Dec 27, 2023
Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 27, 2023
CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CardioQuip, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 27, 2023
AcuMatch Hip System, Catalog Number 142-32-27
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
11 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 27, 2023
Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
FDA (openFDA device enforcement)
Reported Dec 27, 2023
Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Inpeco S.A.
FDA (openFDA device enforcement)
Reported Dec 27, 2023
Injection Needle, REF: 25207
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
4 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 27, 2023
Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
FDA (openFDA device enforcement)
Reported Dec 27, 2023
CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Maquet Medical Systems USA
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.