Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860 Recalled by MEDLINE INDUSTRIES, LP - Northfield Due to Complaints have been received that the device inflation...

Date: February 26, 2024
Company: MEDLINE INDUSTRIES, LP - Northfield
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact MEDLINE INDUSTRIES, LP - Northfield directly.

Affected Products

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.

Quantity: 168,632 tubes and 13,092 kits

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About MEDLINE INDUSTRIES, LP - Northfield

MEDLINE INDUSTRIES, LP - Northfield has 822 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report