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Use caution Medical device recall · FDA · Published February 24, 2025

Medline neonatal intubation trays recalled due to unsafe endotracheal tubes

Medline medical convenience kits with specific neonatal intubation trays and resuscitation kits containing recalled endotracheal tubes. These kits pose a risk of serious injury during medical procedures.

🇺🇸 FDA recall #Z-1505-2025Medical deviceMedline ›
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Recalling firmMEDLINE INDUSTRIES, LP - Northfield3 Lakes Dr · Northfield, IL 60093-2753
✎ GovInfoNow plain-language explainer

Medline has recalled specific neonatal intubation trays and newborn resuscitation kits because they contain endotracheal tubes previously recalled by Smiths Medical. These kits are used in hospitals for infant medical emergencies and could cause serious injury if used improperly. Read more at govinfonow.com/recall/52781-medline-neonatal-intubation-trays-recalled-due-to-unsafe-endotracheal-tubes.

Source Summary by GovInfoNow · govinfonow.com/recall/52781-medline-neonatal-intubation-trays-recalled-due-to-unsafe-endotracheal-tubes · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1505-2025

Cite this page

“Medline neonatal intubation trays recalled due to unsafe endotracheal tubes.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52781-medline-neonatal-intubation-trays-recalled-due-to-unsafe-endotracheal-tubes. Based on FDA recall #Z-1505-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1505-2025%22&limit=1).

The FDA announced on 2025-02-24 that Medline Industries LP voluntarily recalled specific medical convenience kits because they contain intubation tubes previously recalled by Smiths Medical. GovInfoNow's records show the agency issued recall number Z-1505-2025 for the Class I device.

How to tell if you have it

  • NEONATAL INTUBATION TRAY, REF ACC010371C
  • NEWBORN RESUSCITATION KIT, REF ACC010381A
  • NEWBORN RESUSCITATION KIT, REF ACC010381B
  • NEWBORN RESUSCITATION KIT, REF ACC010381C
  • PEDS GREY-PINK-RED, REF ACC010395
  • PEDS PURPLE, REF ACC010397
  • NEONATAL INTUBATION TRAY, REF ACC010541A
  • NEONATAL INTUBATION TRAY, REF ACC010541B
  • NEONATAL INTUBATION TRAY, REF ACC010541C
  • PEDIATRICS INTUBATION TRAY, REF DYNJAA252

The hazard

The recalled kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes that had been previously recalled by Smiths Medical. The FDA classified the recall as Class I.

Context

GovInfoNow's records show MEDLINE INDUSTRIES, LP - Northfield has 119 other recalls on record since 2021-10-22. Other recent recalls of similar products include Medline medical kits recalled due to light failure in intubation trays (2025-07-25), Foley Tray Kits with incorrect labeling risk (2025-07-23), and reprocessed St. Jude Catheters that may contain particulates (2025-07-14). Additional recent recalls include Medline Intubation Tray Recall regarding airway obstruction risk (2025-12-24), Medline Recalls 30+ Medical Kits due to regulatory clearance rescission (2026-02-25), and Medline Medical Procedure Kits Recall for catheter issues (2026-05-04).

How to tell if you have this one

Check for model numbers: ACC010371C, ACC010381A, ACC010381B, ACC010381C, ACC010395, ACC010397, ACC010541A, ACC010541B, ACC010541C, or DYNJAA252. Look for specific lot numbers listed in the recall notice.

  • Brand
    Medline
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Model

    Identify the model number on your Medline kit to see if it matches the recalled list.

  2. Contact Medline

    Reach out to Medline directly for assistance with the recall process.

Where it went and when

Where it was distributed

Distributed in California.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “California” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California.

Recall timeline

FDA published this recall 51 days after the firm started it.

1. Firm started the recall: Feb 24, 202512. FDA classified it Class I: Apr 10, 202523. Published in FDA’s Enforcement Report: Apr 16, 202532025
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1505-2025 (February 24, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1505-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA