FDA Device recalls

FDA device enforcement reports cover medical devices, from test kits to implants. openFDA publishes them roughly weekly with a Class I, II, or III classification.

The 50 most recent FDA Device recalls are below. Every older recall is listed in its year archive.

Recalls by year

2026 (2,024) · 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)

Recent recalls

• 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
• Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y
  FDA Device · Class II · 2026-09-02 · Medline Industries
• Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130
  FDA Device · Class II · 2026-09-02 · Fresenius Medical Care Renal Therapies Group
• Medline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline Kit SKU DYNJT6548
  FDA Device · Class II · 2026-09-02 · Medline Industries
• Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P
  FDA Device · Class II · 2026-09-02 · Medline Industries
• PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209
  FDA Device · Class II · 2026-09-02 · Ge Medical Systems Information Technologies
• Medline medical convenience kits, labeled as: 1) NEURO CDS, Medline Kit SKU CDS985246J
  FDA Device · Class II · 2026-09-02 · Medline Industries
• Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F
  FDA Device · Class II · 2026-09-02 · Medline Industries
• POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action
  FDA Device · Class II · 2026-09-02 · Olympus
• Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330
  FDA Device · Class II · 2026-09-02 · Medline Industries
• Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C
  FDA Device · Class II · 2026-09-02 · Medline Industries
• American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP
  FDA Device · Class II · 2026-09-02 · American Contract Systems
• Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
  FDA Device · Class II · 2026-09-02 · Avid Medical
• Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545
  FDA Device · Class II · 2026-09-02 · Medline Industries
• American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H
  FDA Device · Class II · 2026-09-02 · American Contract Systems