MEDLINE ECVC8395Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10653160368434), received between Sep 26, 2026 and Sep 26, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

47 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2026Difficult to Remove; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906488 ↗

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-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-3229-2026 · Aug 10, 2026 · Open, Classified
  Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F.
• 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-2747-2026 · Jun 5, 2026 · Open, Classified
  MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
• 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-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 32 more.