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.
- Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
FDA Device · Class II · 2026-02-11 · Vortex Surgical - Menopause Test Cassette (Urine)
FDA Device · Class II · 2026-02-11 · Changchun Wancheng Bio Electron - Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These instruments have been de…
FDA Device · Class II · 2026-02-11 · Olympus - PRISMAFLEX HF1000 SET, Product Code 107142
FDA Device · Class II · 2026-02-11 · Vantive Us Healthcare - Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS0740.25 3. 25GA ACTU8 Force…
FDA Device · Class II · 2026-02-11 · Vortex Surgical - MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use…
FDA Device · Class II · 2026-02-11 · Medtronic Minimed - Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not Applicable Product De…
FDA Device · Class II · 2026-02-11 · Fujirebio Diagnostics - Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0730
FDA Device · Class II · 2026-02-11 · Olympus - Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lumipul…
FDA Device · Class II · 2026-02-11 · Fujirebio Diagnostics - *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm
FDA Device · Class I · 2026-02-11 · Boston Scientific - OXIRIS SET, Product Code 112016
FDA Device · Class II · 2026-02-11 · Vantive Us Healthcare - Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
FDA Device · Class II · 2026-02-11 · Changchun Wancheng Bio Electron - Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product Description: These instruments have been de…
FDA Device · Class II · 2026-02-11 · Olympus - Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000
FDA Device · Class II · 2026-02-11 · Intuitive Surgical - NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
FDA Device · Class II · 2026-02-11 · Siemens Medical Solutions Usa - Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product Descrip…
FDA Device · Class II · 2026-02-11 · Fujirebio Diagnostics - PRISMAFLEX ST150 SET US, Product Code 107640US
FDA Device · Class II · 2026-02-11 · Vantive Us Healthcare - Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC433Q-0720
FDA Device · Class II · 2026-02-11 · Olympus - TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
FDA Device · Class II · 2026-02-11 · Tornier - Bubble Sensor for 3/8" x 3/32" tubing
FDA Device · Class II · 2026-02-11 · Maquet Cardiopulmonary - Vortex Surgical 25GA Backflush, VS0270.25
FDA Device · Class II · 2026-02-11 · Vortex Surgical - Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 Product Description: These instruments have been de…
FDA Device · Class II · 2026-02-11 · Olympus - Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L P…
FDA Device · Class II · 2026-02-11 · Olympus - Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0320…
FDA Device · Class II · 2026-02-11 · Olympus - COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-fr…
FDA Device · Class II · 2026-02-11 · Beckman Coulter - Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD
FDA Device · Class II · 2026-02-11 · Vortex Surgical - LH One Step Ovulation Test Device (Urine)
FDA Device · Class II · 2026-02-11 · Changchun Wancheng Bio Electron - VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01…
FDA Device · Class II · 2026-02-11 · Biomerieux - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720
FDA Device · Class II · 2026-02-11 · Olympus - Vivoo pH Test
FDA Device · Class II · 2026-02-11 · Changchun Wancheng Bio Electron - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instruments have been desi…
FDA Device · Class II · 2026-02-11 · Olympus - Male Fertility Sperm Test for Home Use (Cassette)
FDA Device · Class II · 2026-02-11 · Changchun Wancheng Bio Electron - Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720
FDA Device · Class II · 2026-02-11 · Olympus - Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Software Version: Not Applicable Product Descrip…
FDA Device · Class II · 2026-02-11 · Fujirebio Diagnostics - Tecfen Retractable Membrane Polisher, QTPR1267-23
FDA Device · Class II · 2026-02-11 · Vortex Surgical - SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
FDA Device · Class II · 2026-02-11 · Siemens Medical Solutions Usa - Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 Product Description: These instruments…
FDA Device · Class II · 2026-02-11 · Olympus - FDR Visionary Suite
FDA Device · Class II · 2026-02-11 · Fujifilm Healthcare Americas - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330
FDA Device · Class II · 2026-02-11 · Olympus - EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
FDA Device · Class II · 2026-02-11 · Encore Medical - Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3) M1402, (4) M14050, (5) M14150, (6) M1402…
FDA Device · Class II · 2026-02-11 · Etac A S - Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10
FDA Device · Class II · 2026-02-11 · Wilson Cook Medical - Rumex Disposable Diamond Dusted ILM Elevator, 12-7523
FDA Device · Class II · 2026-02-11 · Vortex Surgical - Vortex Surgical I2 Injection Kit, VS0500
FDA Device · Class II · 2026-02-11 · Vortex Surgical - AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm
FDA Device · Class I · 2026-02-11 · Boston Scientific - Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320
FDA Device · Class II · 2026-02-11 · Olympus - Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215
FDA Device · Class II · 2026-02-11 · Olympus - Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These instruments have been de…
FDA Device · Class II · 2026-02-11 · Olympus - NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
FDA Device · Class II · 2026-02-11 · Siemens Medical Solutions Usa - EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H
FDA Device · Class II · 2026-02-11 · Encore Medical - Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. 25GA Laser Probe Flex-Tip Cat…
FDA Device · Class II · 2026-02-11 · Vortex Surgical - Brand Name: Molift Product Name: Molift Mover 300 Model/Catalog Numbers: (1) M1501, (2) M1502, (3) M1504, (4) M15050, (5) M15151, (6) M1500…
FDA Device · Class II · 2026-02-11 · Etac A S - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720
FDA Device · Class II · 2026-02-11 · Olympus - Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These instruments have been de…
FDA Device · Class II · 2026-02-11 · Olympus - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instruments have been desi…
FDA Device · Class II · 2026-02-11 · Olympus - Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
FDA Device · Class II · 2026-02-11 · Vortex Surgical - Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-…
FDA Device · Class II · 2026-02-11 · Olympus - Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
FDA Device · Class II · 2026-02-11 · Vortex Surgical - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730
FDA Device · Class II · 2026-02-11 · Olympus - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instruments have been desi…
FDA Device · Class II · 2026-02-11 · Olympus - PRISMAFLEX TPE2000 SET, Product Code 114093
FDA Device · Class II · 2026-02-11 · Vantive Us Healthcare - Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330
FDA Device · Class II · 2026-02-11 · Olympus - *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm
FDA Device · Class I · 2026-02-11 · Boston Scientific - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instruments have been desi…
FDA Device · Class II · 2026-02-11 · Olympus - 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
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)