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.
- MEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND18350
FDA Device · Class II · 2026-06-24 · Medline Industries - Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F, AHDC KIT: 3L 12 FR X 16 CM/ASK-12123-UOC1, AHDC KIT: 3-L 12 FR X 16 CM…
FDA Device · Class I · 2026-06-24 · Arrow International - ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length
FDA Device · Class II · 2026-06-24 · Conmed - BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication thr…
FDA Device · Class II · 2026-06-24 · Bd Switzerland Sarl - Medline convenience kits: 20CM CVC INSERTION KIT ECVC6805B 2L 8.5FR 16CM CVC INSERTION KIT ECVC8055A VANTEX PI CVC 7F, 3L, 20CM BUNDLE ECVC…
FDA Device · Class II · 2026-06-24 · Medline Industries - Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M1091607-R was installed…
FDA Device · Class I · 2026-06-24 · Datex Ohmeda - Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F
FDA Device · Class I · 2026-06-24 · Arrow International - Description/REF: ACCESS TRAY/ASK-04001-MC3
FDA Device · Class I · 2026-06-24 · Arrow International - Medline convenience kits: BREAST-HERNIA-PORT CDS-LF CDS984853L
FDA Device · Class II · 2026-06-24 · Medline Industries - Medline convenience kits: C SECTION CDS985505G C SECTION PACK DYNJ68260D C-SECTION DYNJ905094B C-SECTION RECOVERY #2 CDS820091P
FDA Device · Class II · 2026-06-24 · Medline Industries - Description/REF: PARACENTESIS KIT/ASK-00376-JHH
FDA Device · Class I · 2026-06-24 · Arrow International - HarmonyAIR A-Series Surgical Lighting System
FDA Device · Class II · 2026-06-24 · Steris - Brand Name: Inspire Medical Systems, Inc
FDA Device · Class II · 2026-06-24 · Inspire Medical Systems - Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC
FDA Device · Class I · 2026-06-24 · Arrow International - Medline convenience kit: SMSC-PELVISCOPY PACK-LF DYNJ0161619M
FDA Device · Class II · 2026-06-24 · Medline Industries - ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length
FDA Device · Class II · 2026-06-24 · Conmed - Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F
FDA Device · Class I · 2026-06-24 · Arrow International - Medline convenience kits: DRIVELINE MANAGEMENT KIT EBSI1688 PORT DRESSING CHANGE KIT EBSI1328A
FDA Device · Class II · 2026-06-24 · Medline Industries - Medline convenience kit: HERNIA REPAIR TOTE DYNJ908337D
FDA Device · Class II · 2026-06-24 · Medline Industries - Centurion convenience kits: CENTRAL LINE DRESSING SV43 FCP DYNDC2356B DIALYSIS CATHETER MAINTENANCE KIT DT17570 DIALYSIS DRESSING CHANGE KI…
FDA Device · Class II · 2026-06-24 · Medline Industries - Medline convenience kits: ACL PACK DYNJ64161C ARTHROSCOPY PACK DYNJ47103D DYNJ67197G DYNJ85197A DYNJT4007 BASIC ACCESS PACK-LF DYNJ36698B B…
FDA Device · Class II · 2026-06-24 · Medline Industries - ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length
FDA Device · Class II · 2026-06-24 · Conmed - MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A
FDA Device · Class II · 2026-06-24 · Medline Industries - Medline convenience kits: C-SECTION KIT DYNJ904305J C-SECTION PACK DYNJ69533C
FDA Device · Class II · 2026-06-24 · Medline Industries - Halyard, Pain Pack
FDA Device · Class II · 2026-06-17 · Avid Medical - Plum Solo Precision IV Pump, 40001-0401
FDA Device · Class II · 2026-06-17 · Icu Medical - Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-6312
FDA Device · Class II · 2026-06-17 · Avanos Medical - Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50
FDA Device · Class II · 2026-06-17 · Boston Scientific - Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Model/Catalog…
FDA Device · Class II · 2026-06-17 · Hf Acquisition - Hintermann Series Talar Implant, Left, Size 2 REF 302112
FDA Device · Class II · 2026-06-17 · Dt Medtech - Bicarby" Dialysate
FDA Device · Class II · 2026-06-17 · Fresenius Medical Care Holdings - Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 Product Description: Feeding Tube Kit Component: No
FDA Device · Class II · 2026-06-17 · Avanos Medical - Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
FDA Device · Class II · 2026-06-17 · Inspiremd - Brand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog Number: 30-5320
FDA Device · Class II · 2026-06-17 · Avanos Medical - Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795
FDA Device · Class II · 2026-06-17 · Siemens Healthcare Diagnostics - Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312
FDA Device · Class II · 2026-06-17 · Avanos Medical - Allia IGS 3 Pulse angiographic X-ray system
FDA Device · Class II · 2026-06-17 · Ge Medical Systems - Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXE…
FDA Device · Class II · 2026-06-17 · The Binding Site Group - Allia IGS Pulse angiographic X-ray system
FDA Device · Class II · 2026-06-17 · Ge Medical Systems - Fresh Roast Systems ColorTrack
FDA Device · Class II · 2026-06-17 · Fresh Roast Systems - Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW Model/Catalog Number: 8170-24
FDA Device · Class II · 2026-06-17 · Avanos Medical - Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20
FDA Device · Class II · 2026-06-17 · Avanos Medical - Plum Duo Precision IV Pump, 40002-0403
FDA Device · Class II · 2026-06-17 · Icu Medical - Allia Moveo angiographic X-ray system
FDA Device · Class II · 2026-06-17 · Ge Medical Systems - Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830
FDA Device · Class II · 2026-06-17 · Inspiremd - NexxZr T Multi A3.5 W98-16mm, REF: 745451
FDA Device · Class II · 2026-06-17 · Sagemax Bioceramics - Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
FDA Device · Class II · 2026-06-17 · Inter Med - Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24
FDA Device · Class II · 2026-06-17 · Avanos Medical - TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM
FDA Device · Class II · 2026-06-17 · D O R C Dutch Opthalmic Research Center Intl B V - Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14
FDA Device · Class II · 2026-06-17 · Avanos Medical - DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035
FDA Device · Class II · 2026-06-17 · Philips North America - Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940
FDA Device · Class II · 2026-06-17 · Inspiremd - Bicarby Dialysate
FDA Device · Class II · 2026-06-17 · Fresenius Medical Care Holdings - Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320
FDA Device · Class II · 2026-06-17 · Avanos Medical - Halyard, Eye Bag Pack
FDA Device · Class II · 2026-06-17 · Avid Medical - Halyard, Drape Pack
FDA Device · Class II · 2026-06-17 · Avid Medical - Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg
FDA Device · Class II · 2026-06-17 · Medartis Ag - Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14
FDA Device · Class II · 2026-06-17 · Avanos Medical - Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20
FDA Device · Class II · 2026-06-17 · Avanos Medical - Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC10-3M,CSK Electrode, ST…
FDA Device · Class II · 2026-06-17 · Boston Scientific Neuromodulation - EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001
FDA Device · Class II · 2026-06-17 · Berlin Heart - Mahurkar Elite PASS Trays
FDA Device · Class II · 2026-06-17 · Mozarc Medical Us - TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM
FDA Device · Class II · 2026-06-17 · D O R C Dutch Opthalmic Research Center Intl B V - MOSAIQ Oncology Information System
FDA Device · Class II · 2026-06-17 · Elekta - Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-5320
FDA Device · Class II · 2026-06-17 · Avanos Medical - Halyard, Towel Six Pack
FDA Device · Class II · 2026-06-17 · Avid Medical - Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320
FDA Device · Class II · 2026-06-17 · Avanos Medical - Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PUSH OTW Model/Catalog Number: 8170-14 Pro…
FDA Device · Class II · 2026-06-17 · Avanos Medical - CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
FDA Device · Class II · 2026-06-17 · Inspiremd - CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040
FDA Device · Class II · 2026-06-17 · Inspiremd - Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
FDA Device · Class II · 2026-06-17 · Boston Scientific Neuromodulation - NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan¿ SuperElastic Compression Staple w…
FDA Device · Class II · 2026-06-17 · In2bones Usa - Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in)
FDA Device · Class II · 2026-06-17 · Boston Scientific Neuromodulation - SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02
FDA Device · Class II · 2026-06-17 · Micromed S P A - Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Model/Catalog…
FDA Device · Class II · 2026-06-17 · Hf Acquisition - Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/Catalog Number: 7170-24 Product Description: Feed…
FDA Device · Class II · 2026-06-17 · Avanos Medical - Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
FDA Device · Class II · 2026-06-17 · Abbott Medical - TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM
FDA Device · Class II · 2026-06-17 · D O R C Dutch Opthalmic Research Center Intl B V - Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog Number: 7170-20 Product Description: Feed…
FDA Device · Class II · 2026-06-17 · Avanos Medical - Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316
FDA Device · Class II · 2026-06-17 · Avanos Medical - Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog Number: 7170-14 Product Description: Feed…
FDA Device · Class II · 2026-06-17 · Avanos Medical - Allia IGS 7 Pulse angiographic X-ray system
FDA Device · Class II · 2026-06-17 · Ge Medical Systems - Plum Duo Infusion Pump, 40002-0401
FDA Device · Class II · 2026-06-17 · Icu Medical - CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930
FDA Device · Class II · 2026-06-17 · Inspiremd - Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catalog Number: 8170-20
FDA Device · Class II · 2026-06-17 · Avanos Medical - Allia IGS 5 Pulse angiographic X-ray system
FDA Device · Class II · 2026-06-17 · Ge Medical Systems - Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog Number: 8180-24
FDA Device · Class II · 2026-06-17 · Avanos Medical - BD Pyxis MedStation ES Tower REF: 352 Medication cabinet
FDA Device · Class II · 2026-06-10 · Carefusion 303 - Digital Angiography System Trinias:UD150G-40 / D150GC-40
FDA Device · Class II · 2026-06-10 · Shimadzu Medical Systems - Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro So…
FDA Device · Class II · 2026-06-10 · Philips Medical Systems Nederland B V - Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 20055717 Model/Catalog Number: 555884 Software Version: N/A Produc…
FDA Device · Class II · 2026-06-10 · B Braun Medical - Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number): SSK H M C 20061890 (560074), SS…
FDA Device · Class I · 2026-06-10 · B Braun Medical - ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
FDA Device · Class II · 2026-06-10 · Siemens Medical Solutions Usa - Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical Knife
FDA Device · Class II · 2026-06-10 · Ssc Surgical Specialties - Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software Ver…
FDA Device · Class II · 2026-06-10 · Advanced Bionics - Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM Model/Catalog Number: 552126 Software Version: N/A Product Des…
FDA Device · Class II · 2026-06-10 · B Braun Medical - BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in., BD¿Quincke Needle 22 G x 3.5 in
FDA Device · Class I · 2026-06-10 · Becton Dickinson And - Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042
FDA Device · Class II · 2026-06-10 · Covidien - Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID Model/Catalog Number: 530184 Software Version: N/A Pr…
FDA Device · Class II · 2026-06-10 · B Braun Medical - BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in
FDA Device · Class I · 2026-06-10 · Becton Dickinson And
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