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Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C; 2)...

FDA Device Recall #Z-1505-2025 — Class I — February 24, 2025

Recall Summary

Recall Number Z-1505-2025
Classification Class I — Serious risk
Date Initiated February 24, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm MEDLINE INDUSTRIES, LP - Northfield
Location Northfield, IL
Product Type Devices
Quantity 1550 units

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.

Distribution Pattern

California

Lot / Code Information

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, 20LDA466, 21ADB162, 21BDB508; 4) REF ACC010381C: UDI/DI 10193489922127 (ea) 40193489922128 (case), Lot Numbers: 21IDA608, 21JDB271, 21KDA979, 21LDA450, 22BDA818, 22FDB822, 22KDB696, 23ADA938, 23CDA005, 23CDB015, 23EDA977, 23FDB762, 23IDB196, 23LDA440, 23LDB579, 24CDA637, 24GDB084, 24IDB423, 24JDB726, 24KDB730; 5) REF ACC010395: UDI/DI 10193489218152 (ea) 40193489218153 (case), Lot Numbers: 20BDC901; 6) REF ACC010397: UDI/DI 10193489218169 (ea) 40193489218160 (case), Lot Numbers: 20CDA453, 20CDA459, 20EDB330; 7) REF ACC010541A: UDI/DI 10195327036980 (ea) 40195327036981 (case), Lot Numbers: 22ADA311; 8) REF ACC010541B: UDI/DI 10195327153649 (ea) 40195327153640 (case), Lot Numbers: 22EDB187; 9) REF ACC010541C: UDI/DI 10198459155765 (ea) 40198459155766 (case), Lot Numbers: 24JDC035; 10) REF DYNJAA252: UDI/DI 10193489297980 (ea) 40193489297981 (case), Lot Numbers: 20EBC867, 20EBD635, 20FBJ920, 22FBF130, 22IBP405

Other Recalls from MEDLINE INDUSTRIES, LP - Northfield

Recall # Classification Product Date
Z-2567-2025 Class I Medline medical convenience kits labeled as: ... Jul 25, 2025
Z-2566-2025 Class I Medline medical convenience kits labeled as: ... Jul 25, 2025
Z-2479-2025 Class II Medline Kits containing BD SureStep Foley Tray ... Jul 23, 2025
Z-2460-2025 Class I Medline ReNewal Reprocessed St. Jude Medical Re... Jul 14, 2025
Z-2452-2025 Class II The Medline General Surgery Tray is customized ... Jul 8, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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