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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Surgical Equipment

Medline Intubation Kits Recalled for Defective Endotracheal Tubes

Agency Publication Date: April 10, 2025
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Summary

Medline Industries, LP is recalling approximately 1,550 neonatal and pediatric intubation and resuscitation kits. These kits were manufactured using endotracheal tubes that were previously recalled by Smiths Medical due to defects. No injuries have been reported in connection with these specific Medline kits, but the use of defective tubes in medical procedures poses significant risks to young patients.

Risk

The endotracheal tubes included in these kits are defective and may fail or malfunction during use. This can lead to airway obstruction, loss of ventilation, or other critical complications for newborn and pediatric patients requiring intubation.

What You Should Do

  1. This recall affects various Medline Neonatal Intubation Trays, Newborn Resuscitation Kits, and Pediatrics Intubation Trays labeled with reference numbers ACC010371C, ACC010381A, ACC010381B, ACC010381C, ACC010395, ACC010397, ACC010541A, ACC010541B, ACC010541C, and DYNJAA252.
  2. Check the reference (REF) number and lot number on the device packaging. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately.
  4. Contact Medline Industries or your medical supply distributor to arrange for the return, replacement, or correction of any kits in your inventory.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action

Firm initiated voluntary recall for correction/return.

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: NEONATAL INTUBATION TRAY
Model / REF:
ACC010371C
Lot Numbers:
20DDA921
20EDC042
20IDC153
21ADB113
21CDB435
21HDB557
21JDA180
21LDB244
22HDB092
22IDA205
22JDA908
22KDA049
22LDA351
23EDC611
UDI:
10193489268188

UDI/DI 10193489268188 (ea) 40193489268189 (case)

Product: NEWBORN RESUSCITATION KIT
Model / REF:
ACC010381A
Lot Numbers:
20BDB854
20FDA703
UDI:
10193489800944

UDI/DI 10193489800944 (ea) 40193489800945 (case)

Product: NEWBORN RESUSCITATION KIT
Model / REF:
ACC010381B
Lot Numbers:
20LDA314
20LDA466
21ADB162
21BDB508
UDI:
10193489457803

UDI/DI 10193489457803 (ea) 401934894578049 (case)

Product: NEWBORN RESUSCITATION KIT
Model / REF:
ACC010381C
Lot Numbers:
21IDA608
21JDB271
21KDA979
21LDA450
22BDA818
22FDB822
22KDB696
23ADA938
23CDA005
23CDB015
23EDA977
23FDB762
23IDB196
23LDA440
23LDB579
24CDA637
24GDB084
24IDB423
24JDB726
24KDB730
UDI:
10193489922127

UDI/DI 10193489922127 (ea) 40193489922128 (case)

Product: PEDS GREY-PINK-RED
Model / REF:
ACC010395
Lot Numbers:
20BDC901
UDI:
10193489218152

UDI/DI 10193489218152 (ea) 40193489218153 (case)

Product: PEDS PURPLE
Model / REF:
ACC010397
Lot Numbers:
20CDA453
20CDA459
20EDB330
UDI:
10193489218169

UDI/DI 10193489218169 (ea) 40193489218160 (case)

Product: NEONATAL INTUBATION TRAY
Model / REF:
ACC010541A
Lot Numbers:
22ADA311
UDI:
10195327036980

UDI/DI 10195327036980 (ea) 40195327036981 (case)

Product: NEONATAL INTUBATION TRAY
Model / REF:
ACC010541B
Lot Numbers:
22EDB187
UDI:
10195327153649

UDI/DI 10195327153649 (ea) 40195327153640 (case)

Product: NEONATAL INTUBATION TRAY
Model / REF:
ACC010541C
Lot Numbers:
24JDC035
UDI:
10198459155765

UDI/DI 10198459155765 (ea) 40198459155766 (case)

Product: PEDIATRICS INTUBATION TRAY
Model / REF:
DYNJAA252
Lot Numbers:
20EBC867
20EBD635
20FBJ920
22FBF130
22IBP405
UDI:
10193489297980

UDI/DI 10193489297980 (ea) 40193489297981 (case)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96472
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Medical Supply Distributors
Manufactured In: United States
Units Affected: 1550 units
Distributed To: California

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.