CLASS I ONGOING Device recall · Reported 16 Apr 2025 · FDA Enforcement Report
Medline medical convenience kits labeled as recalled
Medline Industries LP - Northfield is recalling Medline medical convenience kits labeled as: Neonatal Intubation Tray, distributed in California. The recall was initiated on 24 Feb 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1505-2025
- FDA event ID
- 96472
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 24 Feb 2025
- FDA classified
- 10 Apr 2025
- Reported
- 16 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 24 Feb 2025 | Recall initiated by company | |
| 10 Apr 2025 | Classified by FDA | +45 days |
| 16 Apr 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical.
Product as listed by the FDA
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.
Where it was distributed
California
Questions about this recall
Why was it recalled?
Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical.
Which lots are affected?
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
Where was it sold?
California
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medline Industries LP - Northfield
All 792| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline ReNewal Reprocessed St. Jude Medical Response recalled | Medline Industries LP - Northfield | Particulate Matter | Nationwide |
| Device | CLASS II | The Medline General Surgery Tray is customized to meet recalled | Medline Industries LP - Northfield | Sterility | Nationwide |
| Device | CLASS II | Medline Kits containing BD SureStep Foley Tray Systems recalled | Medline Industries LP - Northfield | Labeling Errors | FL, IL |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |