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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 INDUSTRIES, LP - Northfield: Sub-G Endotracheal Tubes Recalled for Inflation and Suction Failures

Agency Publication Date: May 28, 2024
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Summary

Medline Industries, LP is recalling 168,632 Sub-G Endotracheal Tubes and 13,092 convenience kits containing these tubes due to reports of structural failures. The device's inflation tube may tear or detach from the main tube, leading to a loss of pressure, inability to inflate the cuff, or moisture buildup within the system. Additionally, the suction pump has been reported as difficult to connect or prone to detaching during medical use. These products were distributed nationwide, including to government and military facilities, between approximately 2021 and early 2024.

Risk

If the inflation tube fails or the suction pump detaches, the device may fail to maintain a proper seal in the airway or fail to remove secretions. This can lead to a loss of lung pressure, potential respiratory distress, or the buildup of harmful fluids, posing a critical risk to patients requiring breathing assistance.

What You Should Do

  1. Immediately check your medical inventory for Medline Sub-G Endotracheal Tubes (REF numbers DYNJ18860, DYNJ18865, DYNJ18870, DYNJ18875, DYNJ18880, and DYNJ18885) or convenience kits containing these tubes.
  2. Verify your lot numbers against the extensive list of affected lots, which includes codes such as 23FDC233, 23JDA443, 23ADB410, 24ADA577, 23LDA733, 24BMB124, 23GBI504, 24BBD129, and 24BBE224, among many others provided in the recall documentation.
  3. Identify affected individual tubes using UDI-DI numbers: 20888277652672, 20888277652689, 20888277652696, 20888277652702, 20888277652719, and 20888277657318.
  4. If you are a healthcare provider, contact your hospital's risk management or supply chain department to isolate and stop using any affected endotracheal tubes.
  5. Contact Medline Industries, LP at their Northfield, Illinois headquarters or via the contact information provided in the initial firm notification letter for instructions on returning or replacing affected inventory.
  6. Patients with concerns regarding a device currently in use should consult their healthcare provider immediately.
  7. For additional questions or to report further issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Voluntary Recall - Firm Initiated

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Medline Sub-G Endotracheal Tube with Subglottic Suctioning (6.0 mm ID)
Model / REF:
REF DYNJ18860
UPC Codes:
20888277652672
Product: Medline Sub-G Endotracheal Tube with Subglottic Suctioning (6.5 mm ID)
Model / REF:
REF DYNJ18865
UPC Codes:
20888277652689
Product: Medline Sub-G Endotracheal Tube with Subglottic Suctioning (7.0 mm ID)
Model / REF:
REF DYNJ18870
UPC Codes:
20888277652696
Product: Medline Sub-G Endotracheal Tube with Subglottic Suctioning (7.5 mm ID)
Model / REF:
REF DYNJ18875
UPC Codes:
20888277652702
Product: Medline Sub-G Endotracheal Tube with Subglottic Suctioning (8.0 mm ID)
Model / REF:
REF DYNJ18880
UPC Codes:
20888277652719
Product: Medline Sub-G Endotracheal Tube with Subglottic Suctioning (8.5 mm ID)
Model / REF:
REF DYNJ18885
UPC Codes:
20888277657318
Product: Medline Intubation Kit - Drawer 3 (ACC010502)
Model / REF:
ACC010502
UPC Codes:
10193489846171
40193489846172
Lot Numbers:
23FDC233
23FDB211
23EDC153
23EDB775
23DDB280
23CDB943
23CDA556
22LDA029
22IDA550
22HDA813
22FDC033
22CDC284
21JDC054
21IDB345
21HDB405
21DDB305
Product: Medline Intubation Tube - Drawer 3 (ACC010527)
Model / REF:
ACC010527
UPC Codes:
10193489884333
40193489884334
Lot Numbers:
23JDA443
23IDA363
23IDA232
23HDC331
23HDA117
23GDB600
23FDC372
23FDB913
23FDA966
23FDA310
23EDC371
23EDC154
23EDC094
23EDB732
23EDA387
23CDB838
23CDA557
23BDC008
23BDA945
23ADB791
22LDA005
22JDB800
22HDB976
22HDA451
22GDB041
21LDB937
21LDB416
21JDB262
21IDB491
21IDA193
21GDB207
21FDC754
Product: Medline Adult Intubation Kit (ACC10540)
Model / REF:
ACC10540
UPC Codes:
10193489977547
40193489977548
Lot Numbers:
23ADB410
Product: Medline Adult Intubation Kit (ACC10540A)
Model / REF:
ACC10540A
UPC Codes:
10195327330088
40195327330089
Lot Numbers:
23HDA588
23GDB107
23BDA684
Product: Medline Airway Kit - Drawer 3 (ACC010717)
Model / REF:
ACC010717
UPC Codes:
10195327458997
40195327458998
Lot Numbers:
24ADA577
23LDA731
23IDA629
Product: Medline Airway Kit (DYNDJ1132)
Model / REF:
DYNDJ1132
UPC Codes:
10195327454821
40195327454822
Lot Numbers:
23LDA733
23LDA617
23JDC021
23HDA569
Product: Medline Adult Intubation W Evac (DYNDJ1133)
Model / REF:
DYNDJ1133
UPC Codes:
10195327428532
40195327428533
Lot Numbers:
24BMB124
23LMB682
23HMF259
23HMD765
Product: Medline Backup Kit (DYNJ909501)
Model / REF:
DYNJ909501
UPC Codes:
10195327384852
40195327384853
Lot Numbers:
23GBI504
Product: Medline Backup Kit (DYNJ909501A)
Model / REF:
DYNJ909501A
UPC Codes:
10195327549817
40195327549818
Lot Numbers:
24BBD129
24ABK281
23KBR773
Product: Medline Adult Intubation Tray (DYNJAA269)
Model / REF:
DYNJAA269
UPC Codes:
10195327209049
40195327209040
Lot Numbers:
24BBE224
24ABM718
24ABD835
23LBB055
23JBP694
23JBQ783
23IBU821
23IBF348
23HBP188
23CBX318
23CBX319
23BBR494
23ABI514
22LBI988
22KBH009
22JBH478

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94147
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: government distributors; military distributors
Manufactured In: United States
Units Affected: 168,632 tubes and 13,092 kits
Distributed To: Nationwide

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.

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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.