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.
- ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length
FDA Device · Class II · 2026-06-24 · Conmed - Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1
FDA Device · Class I · 2026-06-24 · Arrow International - Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500
FDA Device · Class II · 2026-06-24 · Ge Medical Systems - Medline convenience kit: KIT: DRESSING CHANGE PED DYNDC3359
FDA Device · Class II · 2026-06-24 · Medline Industries - Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Product Identifiers: M…
FDA Device · Class I · 2026-06-24 · Datex Ohmeda - MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B
FDA Device · Class II · 2026-06-24 · Medline Industries - PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU
FDA Device · Class I · 2026-06-24 · Arrow International - Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRAY/ASK-04001-MS RA C…
FDA Device · Class I · 2026-06-24 · Arrow International - ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Length
FDA Device · Class II · 2026-06-24 · Conmed - Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Pr…
FDA Device · Class II · 2026-06-24 · Thoratec - Description/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH
FDA Device · Class I · 2026-06-24 · Arrow International - MEDLINE Medical Procedure Kits labeled as: LAPAROSCOPY COMBINED - NO NDL, Medline Kit Number/SKU DYNJ37378A
FDA Device · Class II · 2026-06-24 · Medline Industries - MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B
FDA Device · Class II · 2026-06-24 · Medline Industries - Medline convenience kits: BASIC EYE DYNJ905154I TUBAL LIGATION CDS CDS760053K
FDA Device · Class II · 2026-06-24 · Medline Industries - MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE INSERT, ASC T&A, CONWAY T&A SINUS, EAR PACK, etc. (see the recall docume…
FDA Device · Class II · 2026-06-24 · Medline Industries - Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)/AK-04300, CVC KIT: 14 GA X 6 IN/CK-04711
FDA Device · Class I · 2026-06-24 · Arrow International - Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models
FDA Device · Class II · 2026-06-24 · Ge Medical Systems - MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C PACK, D&C HYSTER PACK, FLWR GYN PACK, FS LAP TUBAL…
FDA Device · Class II · 2026-06-24 · Medline Industries - Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
FDA Device · Class II · 2026-06-24 · Amd Medicom - MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Number/SKU DYNJ53973C
FDA Device · Class II · 2026-06-24 · Medline Industries - Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-07155-UPM
FDA Device · Class I · 2026-06-24 · Arrow International - Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers…
FDA Device · Class II · 2026-06-24 · Ge Medical Systems - Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Descriptio…
FDA Device · Class II · 2026-06-24 · Thoratec - Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB
FDA Device · Class I · 2026-06-24 · Arrow International - Impella CP Set with SmartAssist
FDA Device · Class I · 2026-06-24 · Abiomed - ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length
FDA Device · Class II · 2026-06-24 · Conmed - Medline CCI Nerve Block Tray DYNJRA2742 Medline CPNB DYNJRA2716
FDA Device · Class II · 2026-06-24 · Medline Industries - Medline convenience kits: DAVINCI MAIN DYNJ908031D
FDA Device · Class II · 2026-06-24 · Medline Industries - Giraffe Stand-alone Infant Resuscitation System
FDA Device · Class I · 2026-06-24 · Datex Ohmeda - ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 100mm Length
FDA Device · Class II · 2026-06-24 · Conmed - Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC
FDA Device · Class I · 2026-06-24 · Arrow International - MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit Number/SKUDYNJ86253A
FDA Device · Class II · 2026-06-24 · Medline Industries - MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH LITHOTOMY MINOR, TRMC- PERI GYN PACK, RIC…
FDA Device · Class II · 2026-06-24 · Medline Industries - Medline EBSI Kit EBSI1534
FDA Device · Class II · 2026-06-24 · Medline Industries - Description/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE KIT/ASK-01601-MM, THORACENTESIS KIT/AK-01000-T, THORACENTESIS KIT/A…
FDA Device · Class I · 2026-06-24 · Arrow International - Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C
FDA Device · Class II · 2026-06-24 · Amd Medicom - 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
Other years
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