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 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)
Reported Jul 16, 2025
Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 16, 2025
Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts: 1) Uno 102 EE Mobile…
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 16, 2025
VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 16, 2025
Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Canary Medical, Inc.
FDA (openFDA device enforcement)
Reported Jul 16, 2025
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Edwards Lifesciences, LLC
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 16, 2025
Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ge Medical Systems Israel, Functional Imaging
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 16, 2025
Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Given Imaging Ltd.
FDA (openFDA device enforcement)
Reported Jul 16, 2025
O-arm O2 Imaging System. Mobile X-Ray System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.-Boxborough
FDA (openFDA device enforcement)
Reported Jul 16, 2025
Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - Model/Catalog Number: REF I-D-BMF90, 1…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Neurovision Medical Products Inc.
FDA (openFDA device enforcement)
Reported Jul 16, 2025
Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Preat Corp.
FDA (openFDA device enforcement)
Reported Jul 16, 2025
TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Stratasys Ltd.
4 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.