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 Dec 24, 2025
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to…
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 24, 2025
5008X CAREsystem +CLiC +CDX;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
FDA (openFDA device enforcement)
Reported Dec 24, 2025
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare GmbH
FDA (openFDA device enforcement)
Reported Dec 24, 2025
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222;…
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Medical Systems China Co., Ltd.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 24, 2025
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Instrumentation Laboratory
FDA (openFDA device enforcement)
Reported Dec 24, 2025
SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries, LP
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 24, 2025
InPen App, Model/CFN Number: MMT-8061 (Android Users)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
FDA (openFDA device enforcement)
Reported Dec 24, 2025
Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mindray DS USA, Inc. dba Mindray North America
FDA (openFDA device enforcement)
Reported Dec 24, 2025
Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Myofunctional Research Company USA
FDA (openFDA device enforcement)
Reported Dec 24, 2025
MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Path
FDA (openFDA device enforcement)
Reported Dec 24, 2025
Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Rocket Medical PLC
5 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 24, 2025
Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Seaspine Orthopedics Corporation
FDA (openFDA device enforcement)
Reported Dec 24, 2025
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
FDA (openFDA device enforcement)
Reported Dec 24, 2025
Zimmer Air Dermatome, Model/Catalog Number: 00880100100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Surgical Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 17, 2025
Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bard Peripheral Vascular Inc.
FDA (openFDA device enforcement)
Reported Dec 17, 2025
Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Dec 17, 2025
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
Moderate riskThis product could cause temporary or reversible health problems — stop using it.C.R. Bard Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 17, 2025
ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
FDA (openFDA device enforcement)
Reported Dec 17, 2025
Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Datascope Corp.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 17, 2025
ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 17, 2025
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
FDA (openFDA device enforcement)
Reported Dec 17, 2025
MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries, LP
8 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 17, 2025
Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nipro Medical Corporation
FDA (openFDA device enforcement)
Reported Dec 17, 2025
Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number:…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Orthofix U.S. LLC
5 more products 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.