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 Dec 31, 2025
The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
FDA (openFDA device enforcement)
Reported Dec 31, 2025
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 31, 2025
da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
FDA (openFDA device enforcement)
Reported Dec 31, 2025
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported Dec 31, 2025
KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microbiologics Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 31, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
16 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 24, 2025
Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
FDA (openFDA device enforcement)
Reported Dec 24, 2025
Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AVID Medical, Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 24, 2025
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cepheid
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 24, 2025
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Copan Italia
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 24, 2025
Cardiosave Hybrid
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Datascope Corp.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 24, 2025
Intelerad InteleShare software, with ProViewer component
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DICOM Grid, Inc.
FDA (openFDA device enforcement)
Reported Dec 24, 2025
Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 -…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dsaart LLC
5 more products in this recall
FDA (openFDA device enforcement)
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)
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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.