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).