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.
- iLet Bionic Pancreas, REF: BB1001
FDA Device · Class II · 2026-06-24 · Beta Bionics - Description/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A
FDA Device · Class I · 2026-06-24 · Arrow International - BLOCK TRAY DYNJRA2119A INDWELLING NERVE BLOCK DYNJRA1011A
FDA Device · Class II · 2026-06-24 · Medline Industries - Medline convenience kits: FEMORAL BLOCK TRAY DYNJRA1739B
FDA Device · Class II · 2026-06-24 · Medline Industries - Medline convenience kits: PORT A CATH DYNJ906818A
FDA Device · Class II · 2026-06-24 · Medline Industries - Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B
FDA Device · Class I · 2026-06-24 · Arrow International - ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 150mm Length
FDA Device · Class II · 2026-06-24 · Conmed - MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR16C
FDA Device · Class II · 2026-06-24 · Medline Industries - Medline convenience kits: BASIC DYNJ905869G BASIC PACK DYNJ68484B BIB GENERAL LAPAROSCOPY PA DYNJ58305 CHRISTUS CH PEDIATRIC BASIC DYNJ6116…
FDA Device · Class II · 2026-06-24 · Medline Industries - MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ44926G
FDA Device · Class II · 2026-06-24 · Medline Industries - MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYND13508 - 08 Fr
FDA Device · Class II · 2026-06-24 · Medline Industries - Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC
FDA Device · Class I · 2026-06-24 · Arrow International - Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description…
FDA Device · Class II · 2026-06-24 · Thoratec - Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000
FDA Device · Class I · 2026-06-24 · Arrow International - Medtronic O-arm O2 Imaging System
FDA Device · Class II · 2026-06-24 · Medtronic Navigation Boxborough - Medline convenience kits: INPATIENT CENTRAL LN DRSG KIT DYNDC3525 PICC/CVC/MIDLINE DRSG CHG KIT DT13191A PORT A CATH CDS982047S VEIN ABLATI…
FDA Device · Class II · 2026-06-24 · Medline Industries - MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SKU DYNJ908097
FDA Device · Class II · 2026-06-24 · Medline Industries - MEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLORATION ECMO, Medline Kit Number/SKU DYNJ63789A
FDA Device · Class II · 2026-06-24 · Medline Industries - Description/REF: ACCESS TRAY/GU-04020
FDA Device · Class I · 2026-06-24 · Arrow International - MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall…
FDA Device · Class II · 2026-06-24 · Medline Industries - ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length
FDA Device · Class II · 2026-06-24 · Conmed - directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
FDA Device · Class II · 2026-06-24 · Accriva Diagnostics - MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775I
FDA Device · Class II · 2026-06-24 · Medline Industries - Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB
FDA Device · Class I · 2026-06-24 · Arrow International - MINOR CATH LAB PACK DYNJ84775A OR VASCULAR ANGIO PACK DYNJ47269D PORT-A-CATH DYNJ63276G
FDA Device · Class II · 2026-06-24 · Medline Industries - MEDLINE Medical Procedure Kits labeled as: DR FERNANDEZ, Medline kit number/SKU DYNJ68808
FDA Device · Class II · 2026-06-24 · Medline Industries - Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU
FDA Device · Class I · 2026-06-24 · Arrow International - Medline convenience kits: HYSTERECTOMY PACK-LF DYNJ20485L
FDA Device · Class II · 2026-06-24 · Medline Industries - Medline convenience kits: BIB AV FISTULA PACK DYNJ58304B CARDIAC MINOR SURGICOUNT PACK DYNJ56573B ENDOVASCULAR PACK DYNJ29135N EP DEVICE DY…
FDA Device · Class II · 2026-06-24 · Medline Industries - Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A
FDA Device · Class I · 2026-06-24 · Arrow International - MEDLINE Pre-connected Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND10407
FDA Device · Class II · 2026-06-24 · Medline Industries - Description/REF: ACCESS TRAY/ASK-04001-SUH-S
FDA Device · Class I · 2026-06-24 · Arrow International - MEDLINE Medical Procedure Kits labeled as: TONSIL PACK CATH, Medline Kit Number/SKU DYNJ65199A
FDA Device · Class II · 2026-06-24 · Medline Industries - Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180 UDI-DI co…
FDA Device · Class II · 2026-06-24 · Merit Medical Systems - Medline convenience kits: WT LAVH PACK DYNJ46609F
FDA Device · Class II · 2026-06-24 · Medline Industries - MEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK, Medline Kit Number/SKU DYNJ912271
FDA Device · Class II · 2026-06-24 · Medline Industries - Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C
FDA Device · Class II · 2026-06-24 · Philips Medical Systems Nederland B V - Description/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC
FDA Device · Class I · 2026-06-24 · Arrow International - Description/REF: PICC ACCESS TRAY/ASK-04001-CG1
FDA Device · Class I · 2026-06-24 · Arrow International - Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PICC/DELTA: 2L 5.5 FR X 50 CM/ASK-45052-NS AGBA PICC/DELTA KIT:…
FDA Device · Class I · 2026-06-24 · Arrow International - Description/REF: ACCESS TRAY/ASK-04001-JHH
FDA Device · Class I · 2026-06-24 · Arrow International - MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Medline Kit Number/SKU DYNJ68302
FDA Device · Class II · 2026-06-24 · Medline Industries - Medline convenience kits: ABD PACK DYNJ81673B BARIATRIC DYNJ902515K BARIATRIC + DYNJ904119O BARIATRIC CDS CDS983883J BWNBORO LAP CHOLE PACK…
FDA Device · Class II · 2026-06-24 · Medline Industries - Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1
FDA Device · Class I · 2026-06-24 · Arrow International - Description/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2
FDA Device · Class I · 2026-06-24 · Arrow International - Mito Red Light, Super Mobile
FDA Device · Class II · 2026-06-24 · Mito Red Light - Medline convenience kit: (82)LABOR & DELIVERY C-SECTION DYNJ907895F
FDA Device · Class II · 2026-06-24 · Medline Industries - MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/SKU EDUC1044
FDA Device · Class II · 2026-06-24 · Medline Industries - HarmonyAIR A-Series Surgical Lighting System
FDA Device · Class II · 2026-06-24 · Steris - Medline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y PACEMAKER DYNJ56297C PACEMAKER PK DYNJT3454 PACEMAKER/ICD PACK DYNJ338…
FDA Device · Class II · 2026-06-24 · Medline Industries - MEDLINE Medical Procedure Kits labeled as: PELVIC LAP PACK, Medline Kit Number/ SKU DYNJ53820B
FDA Device · Class II · 2026-06-24 · Medline Industries - Automated Impella Controller (AIC), for use with left heart support blood pump
FDA Device · Class I · 2026-06-24 · Abiomed - ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length
FDA Device · Class II · 2026-06-24 · Conmed - Medline convenience kits: BREAST IMAGING DYNJT5893 CHOG PLASTICS SYNJ10306A ENDO BREAST AUGMENTATION PACK DYNJ68023 FACIAL PLASTIC DYNJ9099…
FDA Device · Class II · 2026-06-24 · Medline Industries - Brand Name: Inspire Medical Systems, Inc
FDA Device · Class II · 2026-06-24 · Inspire Medical Systems - Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A
FDA Device · Class I · 2026-06-24 · Arrow International - Medline convenience kit: BHS NEURO DYNJ904900N MEDTRX NEURO PACK DYNJ67267B MRI DBS PACK DYNJ9814630O NEURO CDS-LF CDS983383L NEURO PACK DY…
FDA Device · Class II · 2026-06-24 · Medline Industries - Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva
FDA Device · Class II · 2026-06-24 · Philips Medical Systems Nederland B V - MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents for a full list of p…
FDA Device · Class II · 2026-06-24 · Medline Industries - Description/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP
FDA Device · Class I · 2026-06-24 · Arrow International - TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
FDA Device · Class II · 2026-06-24 · Smith And Nephew - Medline convenience kit: IV START KIT W/HUBGUARD DYNDV2662
FDA Device · Class II · 2026-06-24 · Medline Industries - Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH
FDA Device · Class I · 2026-06-24 · Arrow International - MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW LAP GYN, DEACONESS PELVIC LAP PACK, FLOYD LAP GYN, GY…
FDA Device · Class II · 2026-06-24 · Medline Industries - 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
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)