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 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)
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)
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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.