Medline Sub-G Endotracheal Tube with Subglottic Suctioning: — Class I medical device recall Z-1876-2024
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-06-05, distributed nationwide. Complaints have been received that the device inflation tube detached and/or tore from the main tube, resultin
| Recall number | Z-1876-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-02-26 |
| Classified | 2024-05-28 |
| Reported by FDA | 2024-06-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 10193489846171, 10193489884333, 10193489977547, 10195327209049, 10195327330088, 10195327384852, 10195327428532, 10195327454821, 10195327458997, 10195327549817, 20888277652672, 20888277652689, 20888277652696, 20888277652702, 20888277652719, 20888277657318, 40193489846172, 40193489884334, 40193489977548, 40195327209040, 40195327330089, 40195327384853, 40195327428533, 40195327454822, 40195327458998 and 1 more |
| Lot numbers | 21DDB305, 21FDC754, 21GDB207, 21HDB405, 21IDA193, 21IDB345, 21IDB491, 21JDB262, 21JDC054, 21LDB416, 21LDB937, 22CDC284, 22FDC033, 22GDB041, 22HDA451, 22HDA813, 22HDB976, 22IDA550, 22JBH478, 22JDB800, 22KBH009, 22LBI988, 22LDA005, 22LDA029, 23ABI514, 23ADB410, 23ADB791, 23BBR494, 23BDA684, 23BDA945, 23BDC008, 23CBX318, 23CBX319, 23CDA556, 23CDA557, 23CDB838, 23CDB943, 23DDB280, 23EDA387, 23EDB732 and 43 more |
| Model numbers | DYNJ18860, DYNJ18865, DYNJ18870, DYNJ18875, DYNJ18880, DYNJ18885 |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1876-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.