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.

• 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
  FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group
• Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS
  FDA Device · Class II · 2026-09-09 · Baxter Healthcare
• Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG5…
  FDA Device · Class II · 2026-09-09 · Cardinal Health 200
• Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, LUNG TX CIRCULATOR , Catalog Number: OVC3507…
  FDA Device · Class II · 2026-09-09 · Cardinal Health 200
• Velys Enabling Tech Robotic-Assist Station REF: 451611001
  FDA Device · Class II · 2026-09-09 · Medos International Sarl
• Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators DELUXE PRE OP KIT DYKS2018 GENERAL PREOP KIT DYKS1584A PRE OP KIT…
  FDA Device · Class II · 2026-09-09 · Medline Industries
• Medline Convenience Kits: 1) BLOOD DRAW KIT, Catalog Number: DYLAB1081
  FDA Device · Class II · 2026-09-09 · Medline Industries
• Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,ROBOTICS DH , Catalog Number: PGOCRDNHD
  FDA Device · Class II · 2026-09-09 · Cardinal Health 200
• Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ROBOTIC HYST , Catalog Number: PB41RHRM3
  FDA Device · Class II · 2026-09-09 · Cardinal Health 200
• 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
  FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group
• Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, BLO ROBOTIC GYN , Catalog Number: PBCGRGB28
  FDA Device · Class II · 2026-09-09 · Cardinal Health 200
• Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PINK PERIPHERAL DYNDV1875 BOTTOM DRAWER ACC010972 D…
  FDA Device · Class II · 2026-09-09 · Medline Industries
• Medline Convenience Kits: 1) LABOR CDS, Model Number: CDS981762B
  FDA Device · Class II · 2026-09-09 · Medline Industries
• Medline Convenience Kits: 1) DYKM1414, Catalog Number: DYKM1414
  FDA Device · Class II · 2026-09-09 · Medline Industries
• LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7)
  FDA Device · Class II · 2026-09-09 · Boston Scientific
• Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193
  FDA Device · Class II · 2026-09-09 · Medline Industries
• Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ASLMC CRANIOTOMY , Catalog Number: PNCGCNAUM
  FDA Device · Class II · 2026-09-09 · Cardinal Health 200
• NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 1…
  FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group
• Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL
  FDA Device · Class II · 2026-09-09 · Baxter Healthcare
• Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators C-SECTION PREP DYNJ32702B
  FDA Device · Class II · 2026-09-09 · Medline Industries
• Philips Brilliance
  FDA Device · Class II · 2026-09-09 · Philips North America
• 1) NEURO, (kit) ACNE73-01
  FDA Device · Class II · 2026-09-09 · Avid Medical
• GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B
  FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group
• Medline Convenience Kits: 1) ARTERIAL LINE INSERTION KIT, Model Number: ART1295
  FDA Device · Class II · 2026-09-09 · Medline Industries
• Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT DYKS1583A
  FDA Device · Class II · 2026-09-09 · Medline Industries
• Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325
  FDA Device · Class II · 2026-09-09 · Philips North America
• Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741
  FDA Device · Class II · 2026-09-09 · Medline Industries
• Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BASIN PACK-LF DYNJ42828B EYE BASIN TRAY-LF DYNJ42832B
  FDA Device · Class II · 2026-09-09 · Medline Industries
• Medline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751
  FDA Device · Class II · 2026-09-09 · Medline Industries
• Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232
  FDA Device · Class II · 2026-09-09 · Philips North America
• Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP KIT DYKS1476A
  FDA Device · Class II · 2026-09-09 · Medline Industries
• Medline Convenience Kits: 1) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920
  FDA Device · Class II · 2026-09-09 · Medline Industries
• Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GYN ROBOTIC GSAM , Catalog Number: PBCCGRSGD
  FDA Device · Class II · 2026-09-09 · Cardinal Health 200
• Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, CHONY ORTHO MAJOR SPINE , Catalog Number: PO…
  FDA Device · Class II · 2026-09-09 · Cardinal Health 200
• Halyard medical convenience kits labeled as: 1) ENT, Model/Item Number (kit) ACEN89-01
  FDA Device · Class II · 2026-09-09 · Avid Medical
• 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
  FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group
• Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number: P…
  FDA Device · Class II · 2026-09-09 · Cardinal Health 200
• Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348AA CDS983348AB
  FDA Device · Class II · 2026-09-09 · Medline Industries
• Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ADULT BLOOD CULTURE KIT DYNDH1444D BLOOD CULTR KT DIVRSN DEVICE D…
  FDA Device · Class II · 2026-09-09 · Medline Industries
• Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators IV START KIT LAB DRAW-SH CDS860014Q IV START KIT DYKM1000B IV STA…
  FDA Device · Class II · 2026-09-09 · Medline Industries
• Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) PBCGLVBLI, Catalog Number: KIT, BLO LAVH
  FDA Device · Class II · 2026-09-09 · Cardinal Health 200
• Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number (kit) ANAP22-01
  FDA Device · Class II · 2026-09-09 · Avid Medical
• Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ENT HARVEST , Catalog Number: PEVMETBJX
  FDA Device · Class II · 2026-09-09 · Cardinal Health 200
• Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS860014P
  FDA Device · Class II · 2026-09-09 · Medline Industries
• Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE KIT 2 W/CONNECT DYNDH1487A
  FDA Device · Class II · 2026-09-09 · Medline Industries
• STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074
  FDA Device · Class II · 2026-09-09 · Diagnostica Stago
• Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x
  FDA Device · Class II · 2026-09-09 · Philips North America
• Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA
  FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group
• Medline Convenience Kits: 1) COLORECTAL ME, Model Number: DYNJ906437D
  FDA Device · Class II · 2026-09-09 · Medline Industries
• Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR CDS CDS981762B VAG DELIVERY ADMISSION BAG DYKA1054F
  FDA Device · Class II · 2026-09-09 · Medline Industries
• LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)
  FDA Device · Class II · 2026-09-09 · Boston Scientific
• Medline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F
  FDA Device · Class II · 2026-09-09 · Medline Industries
• Medline Convenience Kits: 1) CDS840396X, Catalog Number: CDS840396X
  FDA Device · Class II · 2026-09-09 · Medline Industries
• Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN KIT DYKA1384B DYKA1384C WELCOME KIT DYKS1206D
  FDA Device · Class II · 2026-09-09 · Medline Industries
• LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8)
  FDA Device · Class II · 2026-09-09 · Boston Scientific
• Medline Convenience Kits: 1) ORTHO ASPIRATION KIT, Model Number: DYKM1636A
  FDA Device · Class II · 2026-09-09 · Medline Industries
• 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
  FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group
• Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ORTHO ASPIRATION KIT DYKM1636A
  FDA Device · Class II · 2026-09-09 · Medline Industries
• Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,GYN LAPAROSCOPY DH , Catalog Number: PBOCGLN17
  FDA Device · Class II · 2026-09-09 · Cardinal Health 200
• Medline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375C
  FDA Device · Class II · 2026-09-09 · Medline Industries
• Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520
  FDA Device · Class II · 2026-09-09 · Medline Industries
• HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF: 10301012 (EU)
  FDA Device · Class II · 2026-09-09 · Johnson And Johnson Surgical Vision
• Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025
  FDA Device · Class II · 2026-09-09 · B Braun Medical
• Medline Convenience Kits: 1) C-SECTION PREP, Model Number: DYNJ32702B
  FDA Device · Class II · 2026-09-09 · Medline Industries
• Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SKU DYNJ9425991S
  FDA Device · Class II · 2026-09-02 · Medline Industries
• Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product Number/SKU HUD78007 (Teleflex Product…
  FDA Device · Class II · 2026-09-02 · Medline Industries
• American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM
  FDA Device · Class II · 2026-09-02 · American Contract Systems
• Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144
  FDA Device · Class II · 2026-09-02 · Philips Healthcare Suzhou
• ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
  FDA Device · Class II · 2026-09-02 · Imris Imaging
• Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A
  FDA Device · Class II · 2026-09-02 · Medline Industries
• CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT Suture Anchor with two, #2 (5 me…
  FDA Device · Class II · 2026-09-02 · Conmed
• Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software Version: Midmark IQecg Plugin versions starting with v10 a…
  FDA Device · Class II · 2026-09-02 · Midmark
• Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U
  FDA Device · Class II · 2026-09-02 · Medline Industries
• Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and intervent…
  FDA Device · Class II · 2026-09-02 · Canon Medical System Usa
• FUJIFILM Synapse PACS software v7.4.310
  FDA Device · Class II · 2026-09-02 · Fujifilm Healthcare Americas
• Medline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q
  FDA Device · Class II · 2026-09-02 · Medline Industries
• Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081 Ch08-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF…
  FDA Device · Class II · 2026-09-02 · Hollister Ulc
• Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
  FDA Device · Class II · 2026-09-02 · Merge Healthcare
• Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI, CIRCUIT, NEO, SING LIMB, HTD,COLUMN, Medline Product Number/SKU HUD78001KIT (…
  FDA Device · Class II · 2026-09-02 · Medline Industries
• healthmark ProChek-W Protein Test for Robotic Arms
  FDA Device · Class II · 2026-09-02 · Healthmark Industries
• Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes: 1) 949-3594, Mfr Product Code 1840
  FDA Device · Class II · 2026-09-02 · Henry Schein
• Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L
  FDA Device · Class II · 2026-09-02 · Medline Industries
• Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F
  FDA Device · Class II · 2026-09-02 · Medline Industries
• Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
  FDA Device · Class II · 2026-09-02 · Avid Medical
• Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19)
  FDA Device · Class II · 2026-09-02 · Medline Industries
• Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
  FDA Device · Class II · 2026-09-02 · Avid Medical
• Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375M
  FDA Device · Class II · 2026-09-02 · Medline Industries
• ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Cov…
  FDA Device · Class II · 2026-09-02 · Imris Imaging
• Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
  FDA Device · Class II · 2026-09-02 · Avid Medical
• Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114-3933, Mfr Product Code 1479
  FDA Device · Class II · 2026-09-02 · Henry Schein
• Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U
  FDA Device · Class II · 2026-09-02 · Medline Industries
• healthmark ProChek-II, Model Number PT-313, PT-201-12
  FDA Device · Class II · 2026-09-02 · Healthmark Industries
• Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
  FDA Device · Class II · 2026-09-02 · Avid Medical
• PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592
  FDA Device · Class II · 2026-09-02 · Ge Medical Systems Information Technologies
• Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27
  FDA Device · Class II · 2026-09-02 · Avid Medical
• PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
  FDA Device · Class II · 2026-09-02 · Ge Medical Systems Information Technologies
• Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
  FDA Device · Class II · 2026-09-02 · Avid Medical
• American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN
  FDA Device · Class II · 2026-09-02 · American Contract Systems
• Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg Plugin versions starting with v10 and pr…
  FDA Device · Class II · 2026-09-02 · Midmark
• FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225
  FDA Device · Class II · 2026-09-02 · Ge Medical Systems Information Technologies

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)