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 Nov 19, 2025
Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Orthofix U.S. LLC
FDA (openFDA device enforcement)
Reported Nov 19, 2025
ProxiDiagnost N90; Model Number: 706110;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems DMC GmbH
5 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 19, 2025
SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Respironics, Inc.
FDA (openFDA device enforcement)
Reported Nov 19, 2025
Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Shimadzu Corporation Medical Systems Division
FDA (openFDA device enforcement)
Reported Nov 19, 2025
IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 19, 2025
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Nov 19, 2025
Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software Version: N/A Product Description:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sonesta Medical AB
FDA (openFDA device enforcement)
Reported Nov 19, 2025
HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
FDA (openFDA device enforcement)
Reported Nov 19, 2025
Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Techno-Path Manufacturing Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 12, 2025
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B-K Medical A/S
5 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 12, 2025
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
FDA (openFDA device enforcement)
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)
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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.