Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone.
Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID; (2) REF DYNJ18865, Polyurethane Cuff 6.5 mm ID; (3) REF DYNJ18870, Polyurethane Cuff 7.0 mm ID; (4) REF DYNJ18875, Polyurethane Cuff 7.5 mm ID; (5) REF DYNJ18880, Polyurethane Cuff 8.0 mm ID; and (6) REF DYNJ18885, Polyurethane Cuff 8.5 mm ID. Medline SubG Endotracheal Tube with Subglottic Suctioning packaged into the following convenience kits: (1) Medline Intubation Kit - Drawer 3, Reorder No. ACC010502, containing 6.0, 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 6 kits/case; (2) Medline Intubation Tube - Drawer 3, Reorder No. ACC010527, containing 6.0, 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 6 kits/case; (3) Medline Adult Intubation, Reorder No. ACC010540, containing 8.5 size subglottic cuff, 3 kits/case; (4) Medline Adult Intubation, Reorder No. ACC010540A, containing 8.5 size subglottic cuff, 3 kits/case; (5) Medline Airway Kit - Drawer 3, Reorder No. ACC010717, containing 6.0, 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 3 kits/case; (6) Medline Airway Kit, Reorder No. DYNDJ1132, containing 7.0, 7.5, and 8.0 sizes subglottic cuff, 26 kits/case; (7) Medline Adult Intubation W Evac, Reorder No. DYNDJ1133, containing 7.0, 7.5, and 8.0 sizes subglottic cuff, 10 kits/case; (8) Medline Backup Kit, Reorder No. DYNJ909501, containing 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 1 kit/package; (9) Medline Backup Kit, Reorder No. DYNJ909501A, containing 6.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 1 kit/package; (10) Medline Adult Intubation Tray, Reorder No. DYNJAA269, containing 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 10 kits/case.
Why it was recalled
Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inflate. There were also reports the suction pump is difficult to connect or detaches during use.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
UDI-DI numbers for the individual tubes: (1) DYNJ18860 - UDI-DI 20888277652672; (2) DYNJ18865 - UDI-DI 20888277652689; (3) DYNJ18870 - UDI-DI 20888277652696; (4) DYNJ18875 - UDI-DI 20888277652702; (5) DYNJ18880 - UDI-DI 20888277652719; (6) DYNJ18885 - UDI-DI 20888277657318. Kit code information: (1) Kit ACC010502 - Kit UDI-DI: 10193489846171; Case UDI-DI: 40193489846172; lot numbers: 23FDC233, 23FDB211, 23EDC153, 23EDB775, 23DDB280, 23CDB943, 23CDA556, 22LDA029, 22IDA550, 22HDA813, 22FDC033, 22CDC284, 21JDC054, 21IDB345, 21HDB405, and 21DDB305; (2) Kit ACC010527 - Kit UDI-DI: 10193489884333; Case UDI-DI: 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, and 21FDC754; (3) Kit ACC10540 - Kit UDI-DI: 10193489977547; Case UDI-DI 40193489977548; lot number: 23ADB410; (4) Kit ACC10540A - Kit UDI-DI 10195327330088; Case UDI-DI 40195327330089; lot numbers: 23HDA588, 23GDB107, and 23BDA684; (5) Kit ACC010717 - Kit UDI-DI 10195327458997; Case UDI-DI 40195327458998; lot numbers: 24ADA577, 23LDA731, and 23IDA629; (6) Kit DYNDJ1132 - Kit UDI-DI 10195327454821; Case UDI-DI 40195327454822; lot numbers: 23LDA733, 23LDA617, 23JDC021, and 23HDA569; (7) Kit DYNDJ1133 - Kit UDI-DI 10195327428532; Case UDI-DI 40195327428533; lot numbers: 24BMB124, 23LMB682, 23HMF259, and 23HMD765; (8) Kit DYNJ909501 - Kit UDI-DI 10195327384852; Case UDI-DI 40195327384853; lot number: 23GBI504; (9) Kit DYNJ909501A - Kit UDI-DI 10195327549817; Case UDI-DI 40195327549818; lot numbers: 24BBD129, 24ABK281, and 23KBR773; (10) Kit DYNJAA269 - Kit UDI-DI 10195327209049; Case UDI-DI 40195327209040; lot numbers: 24BBE224, 24ABM718, 24ABD835, 23LBB055, 23JBP694, 23JBQ783, 23IBU821, 23IBF348, 23HBP188, 23CBX318, 23CBX319, 23BBR494, 23ABI514,22LBI988, 22KBH009, and 22JBH478.
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Distribution was nationwide. There was government/military distributon. Foreign distribution was made to San Salvador and United Arab Emirates.
Recall record
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product type
- Devices
- Recall number
- Z-1876-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Northfield, IL
- Recall initiated
- 2024-02-26
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1876-2024 · Source: openFDA enforcement.