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

Medline medical kits recalled due to defective endotracheal tubes

Medline Industries is recalling approximately 1,550 medical convenience kits containing defective endotracheal tubes manufactured by Smiths Medical. The affected kits include neonatal and pediatric intubation and resuscitation equipment distributed in California.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification mandates a minimum score of 4. Although no illnesses or injuries have been reported, defective endotracheal tubes in neonatal and pediatric intubation kits represent a serious potential hazard in vulnerable patient populations.

Plain-English summary

Medline Industries is recalling specific medical convenience kits containing endotracheal tubes. The affected products include neonatal intubation trays, newborn resuscitation kits, and pediatric intubation kits with product references ACC010371C, ACC010381A, ACC010381B, ACC010381C, ACC010395, ACC010397, ACC010541A, ACC010541B, ACC010541C, and DYNJAA252. Approximately 1,550 units were distributed in California.

The endotracheal tubes included in these kits were manufactured by Smiths Medical and were subsequently recalled by that manufacturer due to defects. These tubes are used for oral and nasal intubation in medical procedures.

The affected kits are intended for use with neonatal and pediatric patients requiring intubation or resuscitation. Healthcare facilities that received these kits can identify affected units using the UDI codes and lot numbers specified in the recall notice.

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 — Respiratory / Intubation Equipment
Hazard
  • device-defect
  • respiratory-risk

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.

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