The Recall Desk
HighFDA (Devices)·Z-1505-2025·Announced 2025-04-16

[pending] Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C; 2) NE

Pending LLM rewrite. Source: FDA_DEVICE Z-1505-2025.

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

Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical.

The recalled product

Product
Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C; 2) NEWBORN RESUSCITATION KIT, REF ACC010381A; 3) NEWBORN RESUSCITATION KIT, REF ACC010381B; 4) NEWBORN RESUSCITATION KIT, REF ACC010381C; 5) PEDS GREY-PINK-RED, REF ACC010395; 6
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 (20)

  • 1) REF ACC010371C: UDI/DI 10193489268188 (ea) 40193489268189 (case)
  • Lot Numbers: 20DDA921
  • 20EDC042
  • 20IDC153
  • 21ADB113
  • 21CDB435
  • 21HDB557
  • 21JDA180
  • 21LDB244
  • 22HDB092
  • 22IDA205
  • 22JDA908
  • 22KDA049
  • 22LDA351
  • 23EDC611
  • 2) REF ACC010381A: UDI/DI 10193489800944 (ea) 40193489800945 (case)
  • Lot Numbers: 20BDB854
  • 20FDA703
  • 3) REF ACC010381B: UDI/DI 10193489457803 (ea) 401934894578049 (case)
  • Lot Numbers: 20LDA314

Distribution

Distribution scope not specified by the agency.

Related recalls

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