FDA Device · 2026
FDA Device recalls in 2026
RecallRadar indexes 2,024 FDA Device recall notices published in 2026. By classification: 254 Class I, 1,736 Class II, 34 Class III.
- AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm
FDA Device · Class I · 2026-02-11 · Boston Scientific - Vivoo Vaginal pH Test
FDA Device · Class II · 2026-02-11 · Changchun Wancheng Bio Electron - Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number: 1430116,1430117,1430115 Produ…
FDA Device · Class II · 2026-02-11 · Etac A S - S. Typhi/Para Typhi A Antigen
FDA Device · Class II · 2026-02-11 · Changchun Wancheng Bio Electron - Brand Name: Molift Product Name: Molift 2-point sling bars (Accessory to mobile hoists) Model/Catalog Numbers: (1) 1530101, (2) 1530102 Pro…
FDA Device · Class II · 2026-02-11 · Etac A S - Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725
FDA Device · Class II · 2026-02-11 · Olympus - Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS064…
FDA Device · Class II · 2026-02-11 · Vortex Surgical - PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc REF: 730-010
FDA Device · Class II · 2026-02-04 · Cerapedics - Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23
FDA Device · Class II · 2026-02-04 · Limflow - Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PACK-LF, Kit SKU DYNJ19974P
FDA Device · Class II · 2026-02-04 · Medline Industries - Genesis Knotless Anchor
FDA Device · Class II · 2026-02-04 · Aju Pharm - Genesis Push-In Suture Anchor
FDA Device · Class II · 2026-02-04 · Aju Pharm - Genesis Screw-In Anchor
FDA Device · Class II · 2026-02-04 · Aju Pharm - Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396
FDA Device · Class II · 2026-02-04 · Philips North America - SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270
FDA Device · Class II · 2026-02-04 · Philips North America - PREGNANCY TEST 24CT
FDA Device · Class II · 2026-02-04 · Gold Star Distribution - Toothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT
FDA Device · Class II · 2026-02-04 · Gold Star Distribution - Fixone Hybrid Anchor
FDA Device · Class II · 2026-02-04 · Aju Pharm - MR 7700
FDA Device · Class II · 2026-02-04 · Philips North America - Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Healt…
FDA Device · Class II · 2026-02-04 · Cardinal Health 200 - Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138
FDA Device · Class II · 2026-02-04 · Philips North America - Upgrade to MR 7700
FDA Device · Class II · 2026-02-04 · Philips North America - Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137
FDA Device · Class II · 2026-02-04 · Philips North America - Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A
FDA Device · Class II · 2026-02-04 · Medline Industries - Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, and 10041 Conductivity Standard Solutions…
FDA Device · Class II · 2026-02-04 · Nipro Technical Services - SmartPath to dStream for 3.0T. Product Code (REF): 782145
FDA Device · Class II · 2026-02-04 · Philips North America - Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF, Kit SKU DYNJ0395022O
FDA Device · Class II · 2026-02-04 · Medline Industries - Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet Systems Model/Catalog Number: 60320010100 Software Version: S…
FDA Device · Class II · 2026-02-04 · Zimmer Surgical - Ingenia Ambition S. Product Code (REF): 782108
FDA Device · Class II · 2026-02-04 · Philips North America - Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software Version: Not Applicable Prod…
FDA Device · Class I · 2026-02-04 · Sunmed Holdings - Evolution Upgrade 3.0T. Product Code (REF): 782143
FDA Device · Class II · 2026-02-04 · Philips North America - Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applicable…
FDA Device · Class I · 2026-02-04 · Sunmed Holdings - Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136
FDA Device · Class II · 2026-02-04 · Philips North America - Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377
FDA Device · Class II · 2026-02-04 · Philips North America - AlternatiV+ Max Knotless Anchor
FDA Device · Class II · 2026-02-04 · Aju Pharm - Medline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE KIT, Kit SKU P903933B
FDA Device · Class II · 2026-02-04 · Medline Industries - 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
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)