Centurion ART685 (UDI 10653160361824)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10653160361824), received between Sep 22, 2026 and Sep 29, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

46 other recalls cover devices cleared under the same FDA submission (K213481); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. May 21, 2026Open, Classified

   The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

   Z-2541-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Blocked Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938818 ↗
• MalfunctionSep 28, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50920233 ↗
• MalfunctionSep 28, 2026Fluid/Blood Leak

  It was reported that "Arterial Line Catheter Stabilization extension set device leaking after insertion" and "Arterial line flushed and fluid spewing from stabilization extension set. Assessment: upon inspection tubing noted to be cracked and blood backing back into system."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50915474 ↗
• MalfunctionSep 22, 2026Fluid/Blood Leak

  It was reported that Aline preparation for patient and the actual tubing leaked at the one of the connections when flushed. Prepped Aline for insertion and confirmed line was flushed recognized saline leakage at connection.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854732 ↗
• OtherSep 22, 2026Fluid/Blood Leak

  It was reported that A-line monitoring extension set (high pressure tube with one way stopcock) had a crack/leaking. Unable to properly flush or get accurate readings of pt's blood pressure due to leak in high pressure extension tubing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853183 ↗
• MalfunctionSep 22, 2026Blocked Connection

  It was reported that "The adapter/connector in the arterial line bundle malfunctioned. The lumen in the connector is not patent."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852933 ↗
• OtherSep 22, 2026Obstruction of Flow; Device Contamination with Chemical or Other Material

  It was reported that ¿connector tubing of Aline insert kit faulty¿ and ¿When inserting Aline and connected tubing, unable to flush¿; ¿When you look at tubing in light you can see what appears to be an extra piece of plastic that is causing obstruction.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852537 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K213481. One submission often covers many models, so check the product and lot details in each record.

• Z-3229-2026 · Aug 10, 2026 · Open, Classified
  Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F.
• Z-3267-2026 · Aug 10, 2026 · Open, Classified
  Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784; 2) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348Q; 3) SLUH CRANIOTOMY PACK-LF, Catalog Number:
• Z-3209-2026 · Jul 31, 2026 · Open, Classified
  Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A
• Z-3137-2026 · Jul 23, 2026 · Open, Classified
  Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
• Z-3070-2026 · Jul 20, 2026 · Open, Classified
  Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PINK PERIPHERAL DYNDV1875 BOTTOM DRAWER ACC010972 DRAWER #4 ACC010479A DRAWER
• Z-3024-2026 · Jul 10, 2026 · Open, Classified
  Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2) GYN LITHOTOMY PACK, Medline Kit SKU DYNJT8166; 3) OPEN HEART PACK, Medline Kit SKU DYNJ
• Z-2995-2026 · Jul 8, 2026 · Open, Classified
  Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056A; 3) ENT SINUS PACK, Medline Kit SKU
• Z-3054-2026 · Jun 12, 2026 · Open, Classified
  Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) PERIPHERAL LAB BLOOD CULTURE KIT, Catalog Number: DYNDH1983A; 3) PEDI EMERGENCY TRAY-PURPLE, Catalog Numb
• Z-2736-2026 · Jun 10, 2026 · Open, Classified
  Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267
• Z-2764-2026 · Jun 8, 2026 · Open, Classified
  MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N
• Z-2749-2026 · Jun 5, 2026 · Open, Classified
  MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A; 2) TOTAL KNEE BASIC, Medline Kit SKU DYNJ902378J; 3) TOTAL HIP, Medline Kit SKU DYNJ903492K;
• Z-2748-2026 · Jun 5, 2026 · Open, Classified
  MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION, Medline SKU DYNJ910835A; medical convenience kits
• Z-2747-2026 · Jun 5, 2026 · Open, Classified
  MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
• Z-2611-2026 · May 28, 2026 · Open, Classified
  Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPEN HEART CDS QVH CDS982523M
• Z-2697-2026 · May 28, 2026 · Open, Classified
  Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2) OPEN HEART PEDS PACK, Model Number: DYNJ88569A; 3) OPEN HEART PEDS PACK, Model Number: DYNJ88569B;

…and 31 more.