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.
- IDM-MULTI-R. Electrical wheelchair component
FDA Device · Class I · 2025-09-10 · Mo Vis Bvba - FloPatch FP120, REF: FP120-FOT01-005
FDA Device · Class III · 2025-09-10 · Flosonics Medical R A 1929803 Ontario - Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme imm…
FDA Device · Class II · 2025-09-10 · Bio Rad Laboratories - Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Number: SW12299 Software V…
FDA Device · Class I · 2025-09-10 · Dexcom - WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020
FDA Device · Class I · 2025-09-10 · Boston Scientific - WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010
FDA Device · Class I · 2025-09-10 · Boston Scientific - Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDIHONEY¿ Non-Adhesive Hy…
FDA Device · Class II · 2025-09-10 · Integra Lifesciences Neurosciences - WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to provide vascular and transseptal access for the family o…
FDA Device · Class I · 2025-09-10 · Boston Scientific - RayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19. 2. RayStation 8A, Software Version: 8.0.0.…
FDA Device · Class II · 2025-09-10 · Raysearch Laboratories Ab - WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020
FDA Device · Class I · 2025-09-10 · Boston Scientific - Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and female…
FDA Device · Class II · 2025-09-10 · Icu Medical - Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product Description: MEDIHONEY¿…
FDA Device · Class II · 2025-09-10 · Integra Lifesciences Neurosciences - Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump
FDA Device · Class I · 2025-09-10 · Baxter Healthcare - Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ Paste with Active Leptos…
FDA Device · Class II · 2025-09-10 · Integra Lifesciences Neurosciences - Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer
FDA Device · Class II · 2025-09-10 · Icu Medical - IDM-MICRO-R. Electrical wheelchair component
FDA Device · Class I · 2025-09-10 · Mo Vis Bvba - WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010
FDA Device · Class I · 2025-09-10 · Boston Scientific - DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
FDA Device · Class I · 2025-09-10 · Medtronic Perfusion Systems - Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer
FDA Device · Class II · 2025-09-10 · Icu Medical - IDM-ARLITE-R. Electrical wheelchair component
FDA Device · Class I · 2025-09-10 · Mo Vis Bvba - InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
FDA Device · Class II · 2025-09-10 · Medtronic Minimed - Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infused with natural medic…
FDA Device · Class II · 2025-09-10 · Integra Lifesciences Neurosciences - Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 31622, 31644 Product Desc…
FDA Device · Class II · 2025-09-10 · Integra Lifesciences Neurosciences - LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-…
FDA Device · Class II · 2025-09-10 · Physio Control - Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series
FDA Device · Class II · 2025-09-10 · Philips Medical Systems Nederland B V - Medshape Universal Joints, REF: DNE-9000-UJ
FDA Device · Class II · 2025-09-10 · Medshape - RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation 9B Service Pack 1, Softwar…
FDA Device · Class II · 2025-09-10 · Raysearch Laboratories Ab - Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
FDA Device · Class II · 2025-09-10 · Visgeneer - Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
FDA Device · Class II · 2025-09-10 · O And M Halyard - Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer
FDA Device · Class II · 2025-09-10 · Icu Medical - WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040
FDA Device · Class I · 2025-09-10 · Boston Scientific - WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010
FDA Device · Class I · 2025-09-10 · Boston Scientific - Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x)
FDA Device · Class II · 2025-09-10 · Philips Medical Systems Nederland B V - All-round Joystick R-net Light
FDA Device · Class I · 2025-09-10 · Mo Vis Bvba - Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM App Model/Catalog Number: SW14245 Softwa…
FDA Device · Class I · 2025-09-10 · Dexcom - TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System
FDA Device · Class II · 2025-09-10 · Premia Spine - Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Versi…
FDA Device · Class I · 2025-09-10 · Dexcom - RayStation with the following product descriptions: 1. RayStation 2023B, Software Version: 14.0.0.3338. 2. RayStation 2024A, Software Versi…
FDA Device · Class II · 2025-09-10 · Raysearch Laboratories Ab - WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040
FDA Device · Class I · 2025-09-10 · Boston Scientific - DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
FDA Device · Class I · 2025-09-10 · Medtronic Perfusion Systems - Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM…
FDA Device · Class II · 2025-09-10 · Boston Scientific Neuromodulation - Micro Joystick R-net
FDA Device · Class I · 2025-09-10 · Mo Vis Bvba - WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020
FDA Device · Class I · 2025-09-10 · Boston Scientific - RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(11)2…
FDA Device · Class II · 2025-09-10 · Reflexion Medical - Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 Product Description: ME…
FDA Device · Class II · 2025-09-10 · Integra Lifesciences Neurosciences - WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010
FDA Device · Class I · 2025-09-10 · Boston Scientific - Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software V…
FDA Device · Class I · 2025-09-10 · Dexcom - Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 Product Description: MediHoney¿ Paste with Act…
FDA Device · Class II · 2025-09-10 · Integra Lifesciences Neurosciences - Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer
FDA Device · Class II · 2025-09-10 · Icu Medical - Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
FDA Device · Class II · 2025-09-10 · Visgeneer - Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x)
FDA Device · Class II · 2025-09-10 · Philips Medical Systems Nederland B V - LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 33…
FDA Device · Class II · 2025-09-10 · Physio Control - NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
FDA Device · Class II · 2025-09-10 · Preat - Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software V…
FDA Device · Class I · 2025-09-10 · Dexcom - RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2. RayStation 6 Service Pack…
FDA Device · Class II · 2025-09-10 · Raysearch Laboratories Ab - Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump
FDA Device · Class I · 2025-09-10 · Baxter Healthcare - Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCS…
FDA Device · Class II · 2025-09-10 · Merge Healthcare - Multi Joystick R-net
FDA Device · Class I · 2025-09-10 · Mo Vis Bvba - RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Service Pack 1, Software…
FDA Device · Class II · 2025-09-10 · Raysearch Laboratories Ab - Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
FDA Device · Class I · 2025-09-10 · Baxter Healthcare - RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStation 11A Service Pack 1, Soft…
FDA Device · Class II · 2025-09-10 · Raysearch Laboratories Ab - Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Model/C…
FDA Device · Class II · 2025-09-10 · Lumicell - RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1, Soft…
FDA Device · Class II · 2025-09-10 · Raysearch Laboratories Ab - RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStation 10B Service Pack 1, Soft…
FDA Device · Class II · 2025-09-10 · Raysearch Laboratories Ab - TRANSDUCER L12-5 Transducer Probe
FDA Device · Class III · 2025-09-03 · Philips Ultrasound - AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I
FDA Device · Class II · 2025-09-03 · American Contract Systems - L12-4 Transducer Probe
FDA Device · Class III · 2025-09-03 · Philips Ultrasound - S4-1 Lumify Transducer Probe
FDA Device · Class III · 2025-09-03 · Philips Ultrasound - C10-3v Transducer Probe
FDA Device · Class III · 2025-09-03 · Philips Ultrasound - Mini Multi TEE Transducer Probe
FDA Device · Class III · 2025-09-03 · Philips Ultrasound - Orascoptic Superior Visualization Custom loupes with Dragonfly frames
FDA Device · Class II · 2025-09-03 · Orascoptic Surgical Acuity - Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Description: The Atlantis intr…
FDA Device · Class II · 2025-09-03 · Dentsply Ih - L8-4 Transducer Probe
FDA Device · Class III · 2025-09-03 · Philips Ultrasound - mC12-3 Transducer Probe
FDA Device · Class III · 2025-09-03 · Philips Ultrasound - V9-2 Transducer Probe
FDA Device · Class III · 2025-09-03 · Philips Ultrasound - X8-2t Transducer Probe
FDA Device · Class III · 2025-09-03 · Philips Ultrasound - S12-4 Transducer Probe
FDA Device · Class III · 2025-09-03 · Philips Ultrasound - BP10-5ec Transducer Probe
FDA Device · Class III · 2025-09-03 · Philips Ultrasound - L9-3 Transducer Probe
FDA Device · Class III · 2025-09-03 · Philips Ultrasound - Spectrum IQ Infusion Pump, Product Code 3570009
FDA Device · Class II · 2025-09-03 · Baxter Healthcare - L15-7IO TRANSDUCER Transducer Probe
FDA Device · Class III · 2025-09-03 · Philips Ultrasound - c5-1 Transducer Probe
FDA Device · Class III · 2025-09-03 · Philips Ultrasound - 7.5MHZ Endo Transducer Probe
FDA Device · Class III · 2025-09-03 · Philips Ultrasound - S8-3 Transducer Probe
FDA Device · Class III · 2025-09-03 · Philips Ultrasound - C9-2 Transducer Probe
FDA Device · Class III · 2025-09-03 · Philips Ultrasound - S9-2 Transducer Probe
FDA Device · Class III · 2025-09-03 · Philips Ultrasound - X6-1 Transducer Probe
FDA Device · Class III · 2025-09-03 · Philips Ultrasound - eL18-4 Transducer Probe
FDA Device · Class III · 2025-09-03 · Philips Ultrasound - D5cwc Transducer Probe
FDA Device · Class III · 2025-09-03 · Philips Ultrasound - AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L
FDA Device · Class II · 2025-09-03 · American Contract Systems - L17-5 Transducer Probe
FDA Device · Class III · 2025-09-03 · Philips Ultrasound - SCNHD LA L7-4 HDI Transducer Probe
FDA Device · Class III · 2025-09-03 · Philips Ultrasound - Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911
FDA Device · Class I · 2025-09-03 · Tandem Diabetes Care - Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR…
FDA Device · Class II · 2025-09-03 · Thor Photomedicine - Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2
FDA Device · Class II · 2025-09-03 · Maquet - Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH…
FDA Device · Class I · 2025-09-03 · Medline Industries Northfield - S7-2t Transducer Probe
FDA Device · Class III · 2025-09-03 · Philips Ultrasound - 3D6-2 Transducer Probe
FDA Device · Class III · 2025-09-03 · Philips Ultrasound - ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants
FDA Device · Class II · 2025-09-03 · Onkos Surgical - BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower / 1…
FDA Device · Class II · 2025-09-03 · Carefusion 303
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)