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.
- BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The BD Pyxis" MedFlex is an Automated Dispensing Cabinet (ADC) intended t…
FDA Device · Class II · 2025-03-05 · Carefusion 303 - A.L.P.S. mvX-P: ANATOMIC LAT FIB PLATE 12H LT- Anatomic Lateral Fibula Plate, 12-Hole, Left
FDA Device · Class II · 2025-03-05 · Tyber Medical - Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible suction pump is intended f…
FDA Device · Class II · 2025-03-05 · Scientia Vascular - ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135
FDA Device · Class II · 2025-03-05 · Terragene - DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software
FDA Device · Class II · 2025-03-05 · Beckman Coulter Laboratory Systems Suzhou - A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H LT-Medial Tibia Plate, 16-Hole, Left Intended for Fixation of fractures of the distal tibia Model/Cata…
FDA Device · Class II · 2025-03-05 · Tyber Medical - A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H LT: Anatomic Lateral Fibula Plate, 8-hole, Left Intended to bridge or otherwise stabilize bone frag…
FDA Device · Class II · 2025-03-05 · Tyber Medical - A.L.P.S. mvX--MEDIAL TIBIA PLATE 12H RT-Medial Tibia Plate, 12-Hole, Right Intended for Fixation of fractures of the distal tibia Model/Cat…
FDA Device · Class II · 2025-03-05 · Tyber Medical - BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the conti…
FDA Device · Class II · 2025-03-05 · Carefusion 303 - Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic…
FDA Device · Class II · 2025-03-05 · Scientia Vascular - Azurion 3 M12
FDA Device · Class I · 2025-02-26 · Philips Medical Systems Nederland B V - Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001
FDA Device · Class II · 2025-02-26 · Dexcom - Augustine Surgical Inc
FDA Device · Class II · 2025-02-26 · Augustine Temperature Management - 3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US PRE3201US Prevena Plus…
FDA Device · Class II · 2025-02-26 · Kci Usa - Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026
FDA Device · Class I · 2025-02-26 · Philips Medical Systems Nederland B V - Azurion 7 M12
FDA Device · Class I · 2025-02-26 · Philips Medical Systems Nederland B V - Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.0.0.24 Software Version: RayStati…
FDA Device · Class II · 2025-02-26 · Raysearch Laboratories Ab - Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia
FDA Device · Class II · 2025-02-26 · Augustine Temperature Management - remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
FDA Device · Class II · 2025-02-26 · Remel - 3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65…
FDA Device · Class II · 2025-02-26 · Kci Usa - Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Software V…
FDA Device · Class II · 2025-02-26 · Raysearch Laboratories Ab - Azurion 3 M15
FDA Device · Class I · 2025-02-26 · Philips Medical Systems Nederland B V - Allura Xper FD20/10
FDA Device · Class I · 2025-02-26 · Philips Medical Systems Nederland B V - Allura Xper FD20/20
FDA Device · Class I · 2025-02-26 · Philips Medical Systems Nederland B V - Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89…
FDA Device · Class II · 2025-02-26 · Raysearch Laboratories Ab - Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 9.1.0.933, 9.2.0.483, 10.0.0.1154,…
FDA Device · Class II · 2025-02-26 · Raysearch Laboratories Ab - Allura Xper FD20 OR Table
FDA Device · Class I · 2025-02-26 · Philips Medical Systems Nederland B V - Allura CV20
FDA Device · Class I · 2025-02-26 · Philips Medical Systems Nederland B V - Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, Model Number DYNJAA254A
FDA Device · Class II · 2025-02-26 · Medline Industries Northfield - AnchorFast, Oral Endotracheal Tube Fastener, REF 9799
FDA Device · Class II · 2025-02-26 · Hollister - AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800
FDA Device · Class II · 2025-02-26 · Hollister - Cardio Vascular-Allura Centron
FDA Device · Class I · 2025-02-26 · Philips Medical Systems Nederland B V - Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia
FDA Device · Class II · 2025-02-26 · Augustine Temperature Management - Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001
FDA Device · Class II · 2025-02-26 · Dexcom - Allura Xper FD20/15
FDA Device · Class I · 2025-02-26 · Philips Medical Systems Nederland B V - Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia
FDA Device · Class II · 2025-02-26 · Augustine Temperature Management - Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001
FDA Device · Class II · 2025-02-26 · Dexcom - Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5.0.3.17 Software Vers…
FDA Device · Class II · 2025-02-26 · Raysearch Laboratories Ab - Augustine Surgical Inc
FDA Device · Class II · 2025-02-26 · Augustine Temperature Management - Allura Xper FD10/10
FDA Device · Class I · 2025-02-26 · Philips Medical Systems Nederland B V - Allura Xper FD20
FDA Device · Class I · 2025-02-26 · Philips Medical Systems Nederland B V - Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397
FDA Device · Class II · 2025-02-26 · Medline Industries Northfield - DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement
FDA Device · Class II · 2025-02-26 · Deroyal Industries - Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.1…
FDA Device · Class II · 2025-02-26 · Raysearch Laboratories Ab - Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm,…
FDA Device · Class I · 2025-02-26 · Spectranetics - LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 11996-000515 Masimo¿ LNCS…
FDA Device · Class II · 2025-02-26 · Physio Control - Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0.1.29, 11.0.3.116 an…
FDA Device · Class II · 2025-02-26 · Raysearch Laboratories Ab - Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2, Model Number ACC010809
FDA Device · Class II · 2025-02-26 · Medline Industries Northfield - Azurion 7 B20
FDA Device · Class I · 2025-02-26 · Philips Medical Systems Nederland B V - Azurion 5 M12
FDA Device · Class I · 2025-02-26 · Philips Medical Systems Nederland B V - Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) and Model Number X080…
FDA Device · Class II · 2025-02-26 · Xtant Medical Holdings - AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700
FDA Device · Class II · 2025-02-26 · Hollister - AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787
FDA Device · Class II · 2025-02-26 · Hollister - Allura Xper FD20 Biplane
FDA Device · Class I · 2025-02-26 · Philips Medical Systems Nederland B V - Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.…
FDA Device · Class II · 2025-02-26 · Raysearch Laboratories Ab - Allura Xper FD20 Biplane OR Table
FDA Device · Class I · 2025-02-26 · Philips Medical Systems Nederland B V - Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.1.1.2, 6.2.0.7, 6.3.0.6 Software…
FDA Device · Class II · 2025-02-26 · Raysearch Laboratories Ab - Allura Xper FD10C
FDA Device · Class I · 2025-02-26 · Philips Medical Systems Nederland B V - Azurion 5 M20
FDA Device · Class I · 2025-02-26 · Philips Medical Systems Nederland B V - remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
FDA Device · Class II · 2025-02-26 · Remel - Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3.68,…
FDA Device · Class II · 2025-02-26 · Raysearch Laboratories Ab - Azurion 7 M20
FDA Device · Class I · 2025-02-26 · Philips Medical Systems Nederland B V - Azurion 7 B12
FDA Device · Class I · 2025-02-26 · Philips Medical Systems Nederland B V - Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System
FDA Device · Class II · 2025-02-26 · Raysearch Laboratories Ab - AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM 140-32-28 AM EHXL 0¿ LNR H…
FDA Device · Class II · 2025-02-19 · Exactech - Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL…
FDA Device · Class II · 2025-02-19 · Exactech - Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104
FDA Device · Class II · 2025-02-19 · Cardinal Health 200 - stryker Precision Thin, Catalog Number REF 2296-003-108
FDA Device · Class II · 2025-02-19 · Stryker - Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234
FDA Device · Class II · 2025-02-19 · Microbiologics - Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11
FDA Device · Class II · 2025-02-19 · Cardinal Health 200 - Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3
FDA Device · Class II · 2025-02-19 · Cardinal Health 200 - Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA
FDA Device · Class II · 2025-02-19 · Cardinal Health 200 - Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM…
FDA Device · Class I · 2025-02-19 · Olympus - MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297
FDA Device · Class II · 2025-02-19 · Microvention - MOSAIQ Oncology Information System
FDA Device · Class II · 2025-02-19 · Elekta - BD Pyxis MedStation 4000 REF: 303
FDA Device · Class II · 2025-02-19 · Carefusion 303 - (1) BD Pyxis MedStation ES, Catalog No. 323
FDA Device · Class II · 2025-02-19 · Carefusion 303 - Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA
FDA Device · Class II · 2025-02-19 · Cardinal Health 200 - Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Des…
FDA Device · Class II · 2025-02-19 · Integra Lifesciences - BD Pyxis MedStation ES (Med ES Main) REF: 323
FDA Device · Class II · 2025-02-19 · Carefusion 303 - Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist…
FDA Device · Class I · 2025-02-19 · Max Mobility - Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B
FDA Device · Class II · 2025-02-19 · Cardinal Health 200 - Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N
FDA Device · Class II · 2025-02-19 · Cardinal Health 200 - (1) Pyxis MedStation ES, Catalog No. 323
FDA Device · Class II · 2025-02-19 · Carefusion 303 - Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4
FDA Device · Class II · 2025-02-19 · Cardinal Health 200 - Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14
FDA Device · Class II · 2025-02-19 · Cardinal Health 200 - Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA
FDA Device · Class II · 2025-02-19 · Cardinal Health 200 - Vaporizer Sevoflurane, Quik-Fil
FDA Device · Class I · 2025-02-19 · Getinge Usa Sales - The MSOT Acuity Echo is a Class 4 medical laser device
FDA Device · Class II · 2025-02-19 · Ithera Medical - Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LN…
FDA Device · Class II · 2025-02-19 · Exactech - Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235
FDA Device · Class II · 2025-02-19 · Microbiologics - BD Pyxis MedStation Auxiliary ES REF: 324
FDA Device · Class II · 2025-02-19 · Carefusion 303 - Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA
FDA Device · Class II · 2025-02-19 · Cardinal Health 200 - Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
FDA Device · Class II · 2025-02-19 · Murata Vios - stryker Precision Thin, Catalog Number REF 2296-003-155
FDA Device · Class II · 2025-02-19 · Stryker - Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600
FDA Device · Class II · 2025-02-19 · Hf Acquisition - BD Pyxis MedStation Auxiliary 4000 REF: 306
FDA Device · Class II · 2025-02-19 · Carefusion 303 - Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Descri…
FDA Device · Class II · 2025-02-19 · Hologic - Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardi…
FDA Device · Class II · 2025-02-19 · Angel Medical Systems - Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist c…
FDA Device · Class I · 2025-02-19 · Max Mobility
Other years
2026 (2,088) · 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)