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 17, 2025
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
FDA (openFDA device enforcement)
Reported Dec 17, 2025
AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 17, 2025
Stryker MV3 bariatric bed, Part Number 5900000001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 17, 2025
Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Waldemar Link GmbH & Co. KG (Mfg Site)
FDA (openFDA device enforcement)
Reported Dec 10, 2025
Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Accriva Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Dec 10, 2025
Olympus OER-Elite
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aizu Olympus Co., Ltd.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 10, 2025
Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Dec 10, 2025
InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Enterix, Inc.
FDA (openFDA device enforcement)
Reported Dec 10, 2025
IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 10, 2025
Alcohol (ALC) Test Saliva
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Get Tested International Ab
91 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 10, 2025
Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Illumina, Inc.
FDA (openFDA device enforcement)
Reported Dec 10, 2025
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic, Inc.
FDA (openFDA device enforcement)
Reported Dec 10, 2025
KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microbiologics Inc.
FDA (openFDA device enforcement)
Reported Dec 10, 2025
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Paragon 28, Inc.
FDA (openFDA device enforcement)
Reported Dec 10, 2025
IntelliVue MP2. Product Number: M8102A.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
23 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 10, 2025
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Ultrasound, LLC
FDA (openFDA device enforcement)
Reported Dec 10, 2025
MAMMOMAT Revelation;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 3, 2025
CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research LLC
FDA (openFDA device enforcement)
Reported Dec 3, 2025
Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Argon Medical Devices, Inc.
FDA (openFDA device enforcement)
Reported Dec 3, 2025
ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B Braun Medical Inc.
115 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 3, 2025
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioFire Diagnostics, LLC
FDA (openFDA device enforcement)
Reported Dec 3, 2025
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cepheid
FDA (openFDA device enforcement)
Reported Dec 3, 2025
DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dermasensor Inc.
FDA (openFDA device enforcement)
Reported Dec 3, 2025
Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Djo, LLC
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.