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 Jul 30, 2025
Biofinity XR Toric Contact Lens
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperVision, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 30, 2025
Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien
FDA (openFDA device enforcement)
Reported Jul 30, 2025
Portable X-ray system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Digimed Co., Ltd.
FDA (openFDA device enforcement)
Reported Jul 30, 2025
Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Encore Medical, LP
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 30, 2025
SIGNA Architect
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 30, 2025
Bodor's I series laser cutting machine.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Jinan Bodor Cnc Machine Co. Ltd.
FDA (openFDA device enforcement)
Reported Jul 30, 2025
ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Johnson & Johnson Vision Care, Inc.
FDA (openFDA device enforcement)
Reported Jul 30, 2025
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 30, 2025
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 30, 2025
Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Natus Neurology dba Excel Tech., Ltd. (XLTEK)
FDA (openFDA device enforcement)
Reported Jul 30, 2025
Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 30, 2025
Azurion 7 M20. Fluoroscopic X-Ray System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
FDA (openFDA device enforcement)
Reported Jul 30, 2025
Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 23, 2025
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 23, 2025
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Jul 23, 2025
Laser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beyond Laser Systems, LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 23, 2025
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Encore Medical, LP
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 23, 2025
SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
FDA (openFDA device enforcement)
Reported Jul 23, 2025
i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Intersurgical Inc.
FDA (openFDA device enforcement)
Reported Jul 23, 2025
Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 23, 2025
KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microbiologics Inc.
FDA (openFDA device enforcement)
Reported Jul 23, 2025
NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.NeuroSync, Inc.
FDA (openFDA device enforcement)
Reported Jul 23, 2025
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 23, 2025
Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Waismed Ltd.
1 more product 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.