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.
- Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is intended…
FDA Device · Class II · 2026-04-29 · Arrow International - Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Tria…
FDA Device · Class II · 2026-04-29 · Foundation Medicine - Soft-Vu Angiographic Catheter, Kumpe, Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics - LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131
FDA Device · Class II · 2026-04-29 · Lsl Healthcare - CUSA Clarity C7000 Console, Software Version: 2.1.1.909
FDA Device · Class II · 2026-04-29 · Integra Lifesciences Neurosciences - Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB
FDA Device · Class II · 2026-04-29 · Medline Industries - MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251…
FDA Device · Class II · 2026-04-29 · Arrow International - Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F
FDA Device · Class II · 2026-04-29 · Medline Industries - Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm
FDA Device · Class II · 2026-04-29 · Olympus - Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M
FDA Device · Class II · 2026-04-29 · Medline Industries - Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
FDA Device · Class II · 2026-04-29 · Diversatek Healthcare - OER-ELITE Endoscope Reprocessor Connecting Tubes
FDA Device · Class II · 2026-04-29 · Olympus - Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics - Flamingo Funnel Medium, Model Number SQ20012-02
FDA Device · Class II · 2026-04-29 · Surgismoke Solutions - nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft Substit…
FDA Device · Class II · 2026-04-29 · Xtant Medical Holdings - AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers
FDA Device · Class II · 2026-04-29 · Angiodynamics - LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555
FDA Device · Class II · 2026-04-29 · Lsl Healthcare - AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers
FDA Device · Class II · 2026-04-29 · Angiodynamics - Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
FDA Device · Class II · 2026-04-29 · Diversatek Healthcare - Flamingo Funnel Large, Model Number SQ20012-03
FDA Device · Class II · 2026-04-29 · Surgismoke Solutions - Soft-Vu Angiographic Catheter, Straight Art, Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics - Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531(11)251205(10)33F25M…
FDA Device · Class II · 2026-04-29 · Arrow International - Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm
FDA Device · Class II · 2026-04-29 · Olympus - Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L
FDA Device · Class II · 2026-04-29 · Medline Industries - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTERIOGRAM TRAY 00-402001T, 00-402001U CATH LAB-VEI…
FDA Device · Class II · 2026-04-29 · Medline Industries - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J
FDA Device · Class II · 2026-04-29 · Medline Industries - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADD A ENDOVASCULAR PACK-LF DYNJ0429339L, DYNJ0429339…
FDA Device · Class II · 2026-04-29 · Medline Industries - The product is a handheld ultraviolet-C germicidal wand and contains a combination of five UV-A and UV-C LED lights
FDA Device · Class II · 2026-04-29 · Uvlizer - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENSEMBLE GYNECO SCOPIE-LF DYNJ53744B LAVH GRH-LF DYN…
FDA Device · Class II · 2026-04-29 · Medline Industries - Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F
FDA Device · Class II · 2026-04-29 · Medline Industries - Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code: (01)10801902218930…
FDA Device · Class II · 2026-04-29 · Arrow International - Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369
FDA Device · Class II · 2026-04-29 · Medline Industries - (1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit
FDA Device · Class II · 2026-04-29 · Magellan Diagnostics - Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
FDA Device · Class II · 2026-04-29 · Medline Industries - ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)26…
FDA Device · Class II · 2026-04-29 · Arrow International - Medline Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C
FDA Device · Class II · 2026-04-29 · Medline Industries - Soft-Vu Angiographic Catheter, Berenstein, Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics - Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777D
FDA Device · Class II · 2026-04-29 · Medline Industries - Medline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440
FDA Device · Class II · 2026-04-29 · Medline Industries - OER-ELITE Endoscope Reprocessor Connecting Tubes
FDA Device · Class II · 2026-04-29 · Olympus - Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B
FDA Device · Class II · 2026-04-29 · Medline Industries - OER-ELITE Endoscope Reprocessor Connecting Tubes
FDA Device · Class II · 2026-04-29 · Olympus - Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
FDA Device · Class II · 2026-04-29 · Diversatek Healthcare - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EXTREMITY PACK DYNJ34846C HAND PACK DYNJ83218A, DYNJ…
FDA Device · Class II · 2026-04-29 · Medline Industries - Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB
FDA Device · Class II · 2026-04-29 · Medline Industries - LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H
FDA Device · Class II · 2026-04-29 · Lsl Healthcare - Flamingo Funnel Small, Model Number SQ20012-01
FDA Device · Class II · 2026-04-29 · Surgismoke Solutions - OER-ELITE Endoscope Reprocessor Connecting Tubes
FDA Device · Class II · 2026-04-29 · Olympus - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOPLASTY PACK DYNJ80343C PLASTIC HEAD-NECK P…
FDA Device · Class II · 2026-04-29 · Medline Industries - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK DYNJ69246B ABDOMINAL VASCULAR-LF DYNJ90529…
FDA Device · Class II · 2026-04-29 · Medline Industries - Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D
FDA Device · Class II · 2026-04-29 · Medline Industries - Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm
FDA Device · Class II · 2026-04-29 · Davol - Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y
FDA Device · Class II · 2026-04-29 · Medline Industries - FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-05502-BSM UDI code: (01)10801902209853(1…
FDA Device · Class II · 2026-04-29 · Arrow International - AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers
FDA Device · Class II · 2026-04-29 · Angiodynamics - The product is a handheld ultraviolet-C germicidal wand and contains two low-pressure mercury bulbs with a peak emission wavelength at 254…
FDA Device · Class II · 2026-04-29 · Uvlizer - Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775
FDA Device · Class II · 2026-04-29 · Medline Industries - Soft-Vu Angiographic Catheter, Kumpe, Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics - Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics - Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
FDA Device · Class II · 2026-04-29 · Windstone Medical Packaging - Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254B
FDA Device · Class II · 2026-04-29 · Medline Industries - LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554
FDA Device · Class II · 2026-04-29 · Lsl Healthcare - OER-ELITE Endoscope Reprocessor Connecting Tubes
FDA Device · Class II · 2026-04-29 · Olympus - Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038
FDA Device · Class II · 2026-04-29 · Medline Industries - Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
FDA Device · Class II · 2026-04-29 · Foundation Medicine - Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR
FDA Device · Class II · 2026-04-29 · Medline Industries - B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A
FDA Device · Class I · 2026-04-22 · B Braun Medical - B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705
FDA Device · Class I · 2026-04-22 · B Braun Medical - Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LE…
FDA Device · Class II · 2026-04-22 · Clariance Sas - Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicabl…
FDA Device · Class II · 2026-04-22 · Therakos Development - B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705
FDA Device · Class I · 2026-04-22 · B Braun Medical - Cytal Wound Matrix 2-Layer 10x15 cm
FDA Device · Class II · 2026-04-22 · Integra Lifesciences Neurosciences - Philips Spectral CT on Rails
FDA Device · Class II · 2026-04-22 · Philips Medical Systems - Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
FDA Device · Class II · 2026-04-22 · Arjohuntleigh Polska Sp Z O O - ARTIS Pheno VE30A and VE40A, Model 10849000
FDA Device · Class II · 2026-04-22 · Siemens Medical Solutions Usa - Cytal Burn Matrix 10x15 cm
FDA Device · Class II · 2026-04-22 · Integra Lifesciences Neurosciences - Cytal Wound Matrix 2-Layer 5x5 cm
FDA Device · Class II · 2026-04-22 · Integra Lifesciences Neurosciences - Cytal Burn Matrix 7x10 cm
FDA Device · Class II · 2026-04-22 · Integra Lifesciences Neurosciences - B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L
FDA Device · Class I · 2026-04-22 · B Braun Medical - Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
FDA Device · Class II · 2026-04-22 · Wilson Cook Medical - B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA
FDA Device · Class I · 2026-04-22 · B Braun Medical - Philips AneurysmFlow
FDA Device · Class II · 2026-04-22 · Philips Medical Systems Nederland B V - LinkBio CORE Workstation, a component of the CORE Shoulder System
FDA Device · Class II · 2026-04-22 · Linkbio - Gentuity HF-OCT Imaging System Model G10-01
FDA Device · Class II · 2026-04-22 · Gentuity - Yeastone Broth, 11ML, 10/BOX YY3462
FDA Device · Class II · 2026-04-22 · Remel - Cytal Wound Matrix 2-Layer 7x10 cm
FDA Device · Class II · 2026-04-22 · Integra Lifesciences Neurosciences - React Health PHOENIX 5L Oxygen Concentrator
FDA Device · Class II · 2026-04-22 · 3b Medical - CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F
FDA Device · Class II · 2026-04-22 · Medline Industries - B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096
FDA Device · Class I · 2026-04-22 · B Braun Medical - iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
FDA Device · Class II · 2026-04-22 · Beta Bionics - Omnipod 5 Pods
FDA Device · Class I · 2026-04-22 · Insulet - COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092
FDA Device · Class II · 2026-04-15 · Cook - Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as foll…
FDA Device · Class I · 2026-04-15 · Medline Industries - Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as foll…
FDA Device · Class I · 2026-04-15 · Medline Industries - B¿R¿A¿H¿M¿S KRYPTOR compact REACT, REF: 89986, used with B¿R¿A¿H¿M¿S PlGF Plus KRYPTOR, REF: 859075N, and run on the B¿R¿A¿H¿M¿S KRYPTOR co…
FDA Device · Class II · 2026-04-15 · Brahms - COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788
FDA Device · Class II · 2026-04-15 · Cook - COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108
FDA Device · Class II · 2026-04-15 · Cook - COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424
FDA Device · Class II · 2026-04-15 · Cook - ARTIS pheno and ARTIS Icono biplane, floor and ceiling
FDA Device · Class II · 2026-04-15 · Siemens Medical Solutions Usa - COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537
FDA Device · Class II · 2026-04-15 · Cook
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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)