Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported April 16, 2025
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) PEDS PURPLE, REF ACC010397; 7) NEONATAL INTUBATION TRAY, REF ACC010541A; 8) NEONATAL INTUBATION TRAY, REF ACC010541B; 9) NEONATAL INTUBATION TRAY, REF ACC010541C; 10) PEDIATRICS INTUBATION TRAY, REF DYNJAA252.
Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical.
Medline Industries, LP - Northfield recalled Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC01037… - a critical-severity action.
Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC01037… was recalled by Medline Industries, LP - Northfield in April 16, 2025. Reason: Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequentl…. Check the official notice for the remedy. Verify recall #Z-1505-2025 with the FDA Devices before acting.
The recall
Medline Industries, LP - Northfield issued this critical-severity FDA Devices recall-Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequentl….
- Critical
- severity level
- 2K units
- affected scope
- Class I
- classification
- April 16, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1505-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1505-2025) was formally reported on April 16, 2025, with the manufacturer initiating the action on February 24, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. Medline Industries, LP - Northfield is listed as the recalling firm, operating out of Northfield, IL. Federal records list the affected scope as 1550 units.
The documented reason for this recall is: Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical. Distribution data in the federal record shows the product reached: California. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1550 units
Related Recalls
6
3 from same agency
Product description
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) PEDS PURPLE, REF ACC010397; 7) NEONATAL INTUBATION TRAY, REF ACC010541A; 8) NEONATAL INTUBATION TRAY, REF ACC010541B; 9) NEONATAL INTUBATION TRAY, REF ACC010541C; 10) PEDIATRICS INTUBATION TRAY, REF DYNJAA252.
Reason for recall
Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1505-2025 |
| Date reported | April 16, 2025 |
| Date initiated | February 24, 2025 |
| Recalling firm | Medline Industries, LP - Northfield |
| Firm location | Northfield, IL |
| Affected scope | 1550 units |
| Distribution | California |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1505-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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) PEDS PURPLE, REF ACC010397; 7) NEONATAL INTUBATION TRAY, REF ACC010541A; 8) NEONATAL INTUBATION TRAY, REF ACC010541B; 9) NEONATAL INTUBATION TRAY, REF ACC010541C; 10) PEDIATRICS INTUBATION TRAY, REF DYNJAA252.. Recalled by Medline Industries, LP - Northfield. Units affected: 1550 units.
Why was this product recalled? ▼
Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 16, 2025. Severity: Critical. Recall number: Z-1505-2025.
Where was the recalled product distributed? ▼
Distribution: California.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1505-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 16, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.