FDA Device · 2025
FDA Device recalls in 2025
RecallRadar indexes 2,908 FDA Device recall notices published in 2025. By classification: 380 Class I, 2,433 Class II, 95 Class III.
- Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P
FDA Device · Class II · 2025-08-06 · Volcano - SafeStar 90 Plus Filter
FDA Device · Class I · 2025-08-06 · Draeger - IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080
FDA Device · Class II · 2025-08-06 · Lts Therapy Systems - ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option…
FDA Device · Class II · 2025-08-06 · Fujifilm Healthcare Americas - LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
FDA Device · Class II · 2025-08-06 · Microbiologics - Philips Allura R8.2.x Systems
FDA Device · Class II · 2025-08-06 · Philips Medical Systems Nederland B V - Molding Equipment
FDA Device · Class II · 2025-08-06 · Apic Yamada America - Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148
FDA Device · Class II · 2025-08-06 · Philips North America - Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
FDA Device · Class II · 2025-08-06 · Remel - Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In…
FDA Device · Class II · 2025-08-06 · Institut Georges Lopez - 3M Ranger Irrigation Fluid Warming Set, REF 24750
FDA Device · Class II · 2025-08-06 · 3m - The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate…
FDA Device · Class II · 2025-08-06 · Implant Direct Sybron Manufacturing - SafeStar 55 Plus Filter
FDA Device · Class I · 2025-08-06 · Draeger - Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011
FDA Device · Class II · 2025-08-06 · Remote Diagnostic Technologies - Ingenia 1.5T S Model Number (REF): 781347
FDA Device · Class II · 2025-08-06 · Philips North America - Achieva XR
FDA Device · Class II · 2025-08-06 · Philips North America - Blood/MacConkey Biplate 100/PK, Product Number R02049
FDA Device · Class II · 2025-08-06 · Remel - Blood/EMB, Levine 100/PK, Product Number R02041
FDA Device · Class II · 2025-08-06 · Remel - Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103
FDA Device · Class II · 2025-08-06 · Philips North America - SafeStar 60A Plus Filter
FDA Device · Class I · 2025-08-06 · Draeger - Sprinter Cart/Sprinter Cart XL Infusion Pole
FDA Device · Class II · 2025-08-06 · Maquet Cardiopulmonary - Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140
FDA Device · Class II · 2025-08-06 · Philips North America - SmartPath to dStream for 3.0T Model Number (REF): 782145
FDA Device · Class II · 2025-08-06 · Philips North America - BostonSight SCLERAL Lens
FDA Device · Class II · 2025-08-06 · Boston Foundation For Sight - Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
FDA Device · Class II · 2025-08-06 · Steris - Strep Selective II Agar, Product Number R01859
FDA Device · Class II · 2025-08-06 · Remel - IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080
FDA Device · Class II · 2025-08-06 · Lts Therapy Systems - LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25)
FDA Device · Class II · 2025-08-06 · Fresenius Kabi Usa - Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMI…
FDA Device · Class I · 2025-08-06 · Hamilton Medical Ag - Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU
FDA Device · Class I · 2025-08-06 · Abiomed - SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144
FDA Device · Class II · 2025-08-06 · Philips North America - Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
FDA Device · Class II · 2025-08-06 · Phasor Health - Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
FDA Device · Class II · 2025-08-06 · Steris - Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY)
FDA Device · Class II · 2025-08-06 · Philips North America - HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
FDA Device · Class II · 2025-08-06 · Heartsine Technologies - Upgrade to MR 7700 Model Number (REF): 782130
FDA Device · Class II · 2025-08-06 · Philips North America - Intera 3.0T Quasar Dual Model Number (REF): 781150
FDA Device · Class II · 2025-08-06 · Philips North America - Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139
FDA Device · Class II · 2025-08-06 · Philips North America - Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105
FDA Device · Class II · 2025-08-06 · Philips North America - MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152
FDA Device · Class II · 2025-08-06 · Philips North America - MR 7700 Model Numbers (REF): (1) 782120, (2) 782153
FDA Device · Class II · 2025-08-06 · Philips North America - Achieva 3.0T
FDA Device · Class II · 2025-08-06 · Philips North America - Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY)
FDA Device · Class II · 2025-08-06 · Philips North America - LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25)
FDA Device · Class II · 2025-08-06 · Fresenius Kabi Usa - Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143
FDA Device · Class II · 2025-08-06 · Philips North America - RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack)
FDA Device · Class II · 2025-08-06 · Siemens Healthcare Diagnostics - LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L
FDA Device · Class II · 2025-08-06 · Microbiologics - LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200
FDA Device · Class II · 2025-08-06 · Microvention - LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20)
FDA Device · Class II · 2025-08-06 · Fresenius Kabi Usa - Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138
FDA Device · Class II · 2025-08-06 · Philips North America - SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no
FDA Device · Class II · 2025-08-06 · Medline Industries Northfield - LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25)
FDA Device · Class II · 2025-08-06 · Fresenius Kabi Usa - HME TwinStar HEPA Plus Filter
FDA Device · Class I · 2025-08-06 · Draeger - Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone seals fit over the biopsy…
FDA Device · Class II · 2025-07-30 · Olympus - Ellik Latex Bulb, Ellik Evacuator
FDA Device · Class II · 2025-07-30 · Olympus - Tubing for Male Connector 194, Ellik Evacuator
FDA Device · Class II · 2025-07-30 · Olympus - Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/Catalog Number: 952-28-40E…
FDA Device · Class II · 2025-07-30 · Encore Medical - Ellik Evacuator
FDA Device · Class II · 2025-07-30 · Olympus - Azurion 7 M20
FDA Device · Class II · 2025-07-30 · Philips Medical Systems Nederland B V - Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10…
FDA Device · Class II · 2025-07-30 · Covidien - Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612
FDA Device · Class II · 2025-07-30 · Olympus - BD COR System Software
FDA Device · Class II · 2025-07-30 · Becton Dickinson And - SIGNA Architect AIR
FDA Device · Class II · 2025-07-30 · Ge Medical Systems - Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip
FDA Device · Class II · 2025-07-30 · Stryker - Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
FDA Device · Class II · 2025-07-30 · Medline Industries Northfield - SIGNA PET/MR
FDA Device · Class II · 2025-07-30 · Ge Medical Systems - Endosee System Convenience Kit with IV Tube
FDA Device · Class II · 2025-07-30 · Coopersurgical - Biofinity XR Toric Contact Lens
FDA Device · Class II · 2025-07-30 · Coopervision - Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYNDH1462B
FDA Device · Class II · 2025-07-30 · Medline Industries Northfield - Natus Brain Monitor Breakout Box, Part Number 021911
FDA Device · Class II · 2025-07-30 · Natus Neurology - Biofinity Toric Multifocal Contact Lens
FDA Device · Class II · 2025-07-30 · Coopervision - Portable X-ray system
FDA Device · Class II · 2025-07-30 · Digimed - Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014P
FDA Device · Class II · 2025-07-30 · Medline Industries Northfield - ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL
FDA Device · Class II · 2025-07-30 · Johnson And Johnson Vision Care - Cone with Male Tubing, Non-Locking, Ellik Evacuator
FDA Device · Class II · 2025-07-30 · Olympus - Endosee System Convenience Kit
FDA Device · Class II · 2025-07-30 · Coopersurgical - Ellik Evacuator Adapter, Locking
FDA Device · Class II · 2025-07-30 · Olympus - Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
FDA Device · Class II · 2025-07-30 · Medline Industries Northfield - SIGNA Architect
FDA Device · Class II · 2025-07-30 · Ge Medical Systems - Discovery MR750w 3.0T
FDA Device · Class II · 2025-07-30 · Ge Medical Systems - Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Softw…
FDA Device · Class II · 2025-07-30 · Medtronic - Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF…
FDA Device · Class II · 2025-07-30 · Bridge To Life - HSG Procedure Tray
FDA Device · Class II · 2025-07-30 · Coopersurgical - Estrone RIA, REF: DSL8700
FDA Device · Class II · 2025-07-30 · Beckman Coulter - Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Sof…
FDA Device · Class II · 2025-07-30 · Medtronic - Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 Model/Catalog Number: 952-28-42F…
FDA Device · Class II · 2025-07-30 · Encore Medical - Bodor's I series laser cutting machine
FDA Device · Class II · 2025-07-30 · Jinan Bodor Cnc Machine - Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
FDA Device · Class II · 2025-07-30 · Stryker - Glass Body For 194 Ellik Evacuator
FDA Device · Class II · 2025-07-30 · Olympus - VITROS Chemistry Products CHE Slides
FDA Device · Class II · 2025-07-23 · Ortho Clinical Diagnostics - Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 Softwar…
FDA Device · Class II · 2025-07-23 · Encore Medical - Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Softwar…
FDA Device · Class II · 2025-07-23 · Ortho Clinical Diagnostics - Laser light show projectors manufactured by BLS, Model PURE 5000/10000
FDA Device · Class II · 2025-07-23 · Beyond Laser Systems - Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Ast…
FDA Device · Class II · 2025-07-23 · Medtronic - VITROS Chemistry Products CHE Slides (Japan)
FDA Device · Class II · 2025-07-23 · Ortho Clinical Diagnostics - Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Az…
FDA Device · Class II · 2025-07-23 · Medtronic - Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
FDA Device · Class I · 2025-07-23 · Baxter Healthcare - i-view video laryngoscope
FDA Device · Class I · 2025-07-23 · Intersurgical - Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number: 341-10-711 Softwar…
FDA Device · Class II · 2025-07-23 · Encore Medical - NeuroSync EYE-SYNC containing Pico Neo 2 Headsets
FDA Device · Class II · 2025-07-23 · Neurosync
Other years
2026 (2,024) · 2025 (2,908) · 2024 (3,393) · 2023 (2,477) · 2022 (2,191) · 2021 (2,303) · 2020 (3,055) · 2019 (2,801) · 2018 (3,757) · 2017 (2,615) · 2016 (3,246) · 2015 (2,495) · 2014 (3,059) · 2013 (2,249) · 2012 (1,310)