The Recall Desk
HighFDA (Devices)·Z-1709-2025·Announced 2025-05-07

[pending] Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK

Pending LLM rewrite. Source: FDA_DEVICE Z-1709-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.

The recalled product

Product
Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B; 3) SHEATH REMOVAL TRAY, REF DYNDC1311C; 4) SENSITIVE SKIN WEEKLY VAD, REF DYNDC3185; 5) NURSING SKILLS, REF EDUC05015A; 6) NURSING SUPPLY BAG, REF EDUC102
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

  • 1) REF DYNDA1359A: UDI/DI 10195327417734 (EA) 40195327417735 (CS)
  • Lot Numbers: 23KBW508
  • 2) REF DYNDA1360B: UDI/DI 10889942903863 (EA) 40889942903864 (CS)
  • Lot Numbers: 23KBB406
  • 3) REF DYNDC1311C: UDI/DI 10080196151561 (EA) 40080196151562 (CS)
  • Lot Numbers: 23KBX338
  • 4) REF DYNDC3185: UDI/DI 10195327034108 (EA) 40195327034109 (CS)
  • Lot Numbers: 23KBX632
  • 5) REF EDUC05015A: UDI/DI 10193489849035 (EA) 40193489849036 (CS)
  • Lot Numbers: 23LDA746
  • 23LDA814
  • 23LDA218
  • 6) REF EDUC1024A: UDI/DI 10195327493165 (EA) 40195327493166 (CS)
  • Lot Numbers: 23LDA281
  • 23KDA001.

Distribution

Distributed nationwide across the United States.

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