MEDLINE INDUSTRIES, LP - Northfield medical device recall: Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION…
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 96472
- Recall initiated
- Feb 24, 2025
- Classified by FDA
- Apr 10, 2025
- Posted in Enforcement Report
- Apr 16, 2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Firm location
- Northfield, IL, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Feb 24, 2025. FDA classified it 45 days later, on Apr 10, 2025. Distribution reported by FDA: California MEDLINE INDUSTRIES, LP - Northfield has 257 recalls in our records.
Recalled products (1)
Z-1505-2025 Class I Ongoing
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.
Codes / lots: 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…
Quantity: 1550 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 96472
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.