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 Nov 12, 2025
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 12, 2025
Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Elekta, Inc.
FDA (openFDA device enforcement)
Reported Nov 12, 2025
CODMAN Disposable Perforator 11mm. Cranial Perforator.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Integra LifeSciences Corp. (NeuroSciences)
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 12, 2025
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mozarc Medical US LLC
5 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 12, 2025
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.OSSTEM Implant Co., Ltd.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 12, 2025
Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Prismatik Dentalcraft, Inc.
FDA (openFDA device enforcement)
Reported Nov 12, 2025
Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spacelabs Healthcare, Ltd.
FDA (openFDA device enforcement)
Reported Nov 12, 2025
Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Tandem Diabetes Care, Inc.
FDA (openFDA device enforcement)
Reported Nov 12, 2025
Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Total Joint Orthopedics, Inc.
FDA (openFDA device enforcement)
Reported Nov 12, 2025
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 5, 2025
Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 5, 2025
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research LLC
5 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 5, 2025
SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ASP Global, LLC. dba Anatomy Supply Partners, LLC.
FDA (openFDA device enforcement)
Reported Nov 5, 2025
Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Balt USA, LLC
FDA (openFDA device enforcement)
Reported Nov 5, 2025
CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Nov 5, 2025
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Canon Medical System, USA, Inc.
FDA (openFDA device enforcement)
Reported Nov 5, 2025
Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-01…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 5, 2025
Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cepheid
FDA (openFDA device enforcement)
Reported Nov 5, 2025
9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Daye (anne's Day Ltd)
28 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 5, 2025
Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Dexcom, Inc.
FDA (openFDA device enforcement)
Reported Nov 5, 2025
Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product Description: The Endomag Magseed Pro Magnetic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Endomagnetics Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 5, 2025
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
FDA (openFDA device enforcement)
Reported Nov 5, 2025
Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Greiner Bio-One North America, Inc.
FDA (openFDA device enforcement)
Reported Nov 5, 2025
ChemoLock Bag Spike, 01 units REF: CL-10-10
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
37 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.