FDA Device · 2026
FDA Device recalls in 2026
RecallRadar indexes 2,388 FDA Device recall notices published in 2026. By classification: 287 Class I, 2,066 Class II, 35 Class III.
- Fixone Biocomposite Anchor
FDA Device · Class II · 2026-02-04 · Aju Pharm - Medline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, Kit SKU DYNJ0660040R
FDA Device · Class II · 2026-02-04 · Medline Industries - Alphenix INFX-8000V, interventional fluoroscopic x-ray system
FDA Device · Class II · 2026-02-04 · Canon Medical System Usa - Bandages and first aid kits: FIRST AID KIT 24/42PC, LUCKY FIRST AID BANDAGES 24CT
FDA Device · Class II · 2026-02-04 · Gold Star Distribution - Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY, Kit SKU ACC010270A
FDA Device · Class II · 2026-02-04 · Medline Industries - Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116
FDA Device · Class II · 2026-02-04 · Philips North America - Ingenia 3.0T CX. Product Code (REF): 781271
FDA Device · Class II · 2026-02-04 · Philips North America - Genesis Dual Thread Screw-In Anchor
FDA Device · Class II · 2026-02-04 · Aju Pharm - Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Version: S…
FDA Device · Class II · 2026-02-04 · Zimmer Surgical - Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, Kit SKU DYNJRA2713
FDA Device · Class II · 2026-02-04 · Medline Industries - BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump a…
FDA Device · Class II · 2026-02-04 · Carefusion 303 - Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A…
FDA Device · Class II · 2026-02-04 · Elekta - Alphenix INFX-8000H, interventional fluoroscopic x-ray system
FDA Device · Class II · 2026-02-04 · Canon Medical System Usa - Feminine hygiene products, labeled as: KOTEX FREEDOM MAXI NO WINGS 48CT, ALWAYS THIN LINERS UNSCENTED 12 CT, ALWAYS THIN LINERS SCENTED 12C…
FDA Device · Class II · 2026-02-04 · Gold Star Distribution - Alphenix INFX-8000F, interventional fluoroscopic x-ray system
FDA Device · Class II · 2026-02-04 · Canon Medical System Usa - Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Version: Not Applicable…
FDA Device · Class I · 2026-02-04 · Sunmed Holdings - Condoms, labeled as: TROJAN MAGNUM CONDOMS 6/DSP BLACK, TROJAN LUBRICATED CONDOMS 6/DSP LITE BLUE, TROJAN SPERMICIDE CONDOMS 6/DSP DARK BLU…
FDA Device · Class II · 2026-02-04 · Gold Star Distribution - LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit
FDA Device · Class II · 2026-02-04 · Lsl Healthcare - Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-LF, Kit SKU DYNJ0275635M
FDA Device · Class II · 2026-02-04 · Medline Industries - Medline medical procedure convenience kits labeled as: CIRCUMCISION PACK, Kit SKU DYNJ16826O
FDA Device · Class II · 2026-02-04 · Medline Industries - Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T
FDA Device · Class II · 2026-02-04 · Siemens Medical Solutions Usa - Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R
FDA Device · Class II · 2026-02-04 · Siemens Medical Solutions Usa - Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAKER PACK-LF, Kit SKU DYNJ64837C
FDA Device · Class II · 2026-02-04 · Medline Industries - Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL LN DRG CHG, Kit SKU DT22880
FDA Device · Class II · 2026-02-04 · Medline Industries - AlternatiV+ Screw-In Anchor
FDA Device · Class II · 2026-02-04 · Aju Pharm - Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit SKU DYNJ35494C
FDA Device · Class II · 2026-02-04 · Medline Industries - Medline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS, Kit SKU CDS984347O
FDA Device · Class II · 2026-02-04 · Medline Industries - Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Version: Not Applicable…
FDA Device · Class I · 2026-02-04 · Sunmed Holdings - Alphenix INFX-8000C, interventional fluoroscopic x-ray system
FDA Device · Class II · 2026-02-04 · Canon Medical System Usa - Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT CDS-LF, Kit SKU CDS984853L
FDA Device · Class II · 2026-02-04 · Medline Industries - Medline medical procedure convenience kits labeled as: 1) DEPAUL BASIC NEURO-LF, Kit SKU DYNJ20028L
FDA Device · Class II · 2026-02-04 · Medline Industries - BEAR Implant
FDA Device · Class II · 2026-02-04 · Miach Orthopaedics - MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR107003LO
FDA Device · Class I · 2026-01-28 · Medline Industries - Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable devi…
FDA Device · Class II · 2026-01-28 · Edan Diagnostics - Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K0…
FDA Device · Class II · 2026-01-28 · Merit Medical Systems - Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient moni…
FDA Device · Class II · 2026-01-28 · Edan Diagnostics - Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Sp…
FDA Device · Class II · 2026-01-28 · Edan Diagnostics - Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monitor System (hereinafter…
FDA Device · Class II · 2026-01-28 · Edan Diagnostics - Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320
FDA Device · Class II · 2026-01-28 · Community Products - Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters…
FDA Device · Class II · 2026-01-28 · Edan Diagnostics - Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product Descr…
FDA Device · Class II · 2026-01-28 · Microport Orthopedics - RayStation/RayPlan
FDA Device · Class II · 2026-01-28 · Raysearch Laboratories Ab - RayStation/RayPlan
FDA Device · Class II · 2026-01-28 · Raysearch Laboratories Ab - Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series Patient Monitor can pe…
FDA Device · Class II · 2026-01-28 · Edan Diagnostics - GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - ME…
FDA Device · Class II · 2026-01-28 · Ge Medical Systems Israel Functional Imaging - Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Mon…
FDA Device · Class II · 2026-01-28 · Edan Diagnostics - Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (here…
FDA Device · Class II · 2026-01-28 · Edan Diagnostics - Philips Azurion system
FDA Device · Class II · 2026-01-28 · Philips Medical Systems Nederland B V - MEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed, REF MDR107002E
FDA Device · Class I · 2026-01-28 · Medline Industries - MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO
FDA Device · Class I · 2026-01-28 · Medline Industries - Rifton Equipment, TRAM. Model/Catalog Number: K310
FDA Device · Class II · 2026-01-28 · Community Products - Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130…
FDA Device · Class II · 2026-01-28 · Merit Medical Systems - Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description: The Vital Signs Monitor is a portable dev…
FDA Device · Class II · 2026-01-28 · Edan Diagnostics - MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E
FDA Device · Class I · 2026-01-28 · Medline Industries - Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Model/Catalog Number: 0…
FDA Device · Class II · 2026-01-28 · Tyber Medical - TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00…
FDA Device · Class II · 2026-01-28 · Sysmex America - Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation…
FDA Device · Class II · 2026-01-28 · Raysearch Laboratories Ab - Allwell Angioplasty Pack REF: IS-30-B1/B
FDA Device · Class II · 2026-01-28 · Merit Medical Systems - The LDL-Cholesterol assay is comprised of two distinct phases
FDA Device · Class II · 2026-01-28 · Beckman Coulter Ireland - Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
FDA Device · Class II · 2026-01-28 · Merit Medical Systems - Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The iM series Patient Moni…
FDA Device · Class II · 2026-01-28 · Edan Diagnostics - Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Descriptio…
FDA Device · Class II · 2026-01-28 · Intuitive Surgical - ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
FDA Device · Class II · 2026-01-28 · Icu Medical - Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vit…
FDA Device · Class II · 2026-01-28 · Edan Diagnostics - Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023B, Ra…
FDA Device · Class II · 2026-01-28 · Raysearch Laboratories Ab - Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000
FDA Device · Class II · 2026-01-28 · Icu Medical - MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L
FDA Device · Class I · 2026-01-28 · Medline Industries - Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal m…
FDA Device · Class II · 2026-01-28 · Edan Diagnostics - RayStation/RayPlan
FDA Device · Class II · 2026-01-28 · Raysearch Laboratories Ab - Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RaySta…
FDA Device · Class II · 2026-01-28 · Raysearch Laboratories Ab - Mazor X robotic guidance system REF: TPL0059
FDA Device · Class II · 2026-01-28 · Mazor Robotics - Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product Description: The devic…
FDA Device · Class II · 2026-01-28 · Edan Diagnostics - Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring…
FDA Device · Class II · 2026-01-28 · Edan Diagnostics - Rifton Equipment, E-Pacer
FDA Device · Class II · 2026-01-28 · Community Products - Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors i…
FDA Device · Class II · 2026-01-28 · Edan Diagnostics - Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Descripti…
FDA Device · Class II · 2026-01-28 · Raysearch Laboratories Ab - Merit Medical , Custom Manifold Kit REF: K09-13203A
FDA Device · Class II · 2026-01-28 · Merit Medical Systems - Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: RayStati…
FDA Device · Class II · 2026-01-28 · Raysearch Laboratories Ab - SQ40S Blood Transfusion Filter
FDA Device · Class II · 2026-01-28 · Gvs Tm - ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
FDA Device · Class II · 2026-01-28 · Icu Medical - Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 0…
FDA Device · Class II · 2026-01-28 · Tyber Medical - MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L
FDA Device · Class I · 2026-01-28 · Medline Industries - Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Product Description: The Leas…
FDA Device · Class II · 2026-01-28 · Leaseir Technologies Slu - Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
FDA Device · Class II · 2026-01-28 · Merit Medical Systems - ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
FDA Device · Class II · 2026-01-28 · Icu Medical - Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description…
FDA Device · Class II · 2026-01-28 · Raysearch Laboratories Ab - SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
FDA Device · Class II · 2026-01-28 · Baxter Healthcare - Patient Information Center iX
FDA Device · Class II · 2026-01-28 · Philips North America - Allwell Inflation Device, for angiographic use REF: IS-30-A
FDA Device · Class II · 2026-01-28 · Merit Medical Systems - Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and M…
FDA Device · Class II · 2026-01-28 · Edan Diagnostics - Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14…
FDA Device · Class II · 2026-01-21 · Medtronic - Brand Name: PALACOS Product Name: PALACOS R pro 40
FDA Device · Class II · 2026-01-21 · Heraeus Medical Dental Division - Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-PLASTIC CRANIOFACIAL PK-LF, Medline…
FDA Device · Class II · 2026-01-21 · Medline Industries - A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200
FDA Device · Class II · 2026-01-21 · Medtronic Neuromodulation - Allura Xper FD10
FDA Device · Class II · 2026-01-21 · Philips Medical Systems Nederland B V - CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016
FDA Device · Class II · 2026-01-21 · Thoratec - Allura Xper FD10/10
FDA Device · Class II · 2026-01-21 · Philips Medical Systems Nederland B V - Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF
FDA Device · Class II · 2026-01-21 · Medline Industries - Allura Xper FD20
FDA Device · Class II · 2026-01-21 · Philips Medical Systems Nederland B V - Allura Xper FD10F
FDA Device · Class II · 2026-01-21 · Philips Medical Systems Nederland B V
Other years
2026 (2,388) · 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)