Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94147

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 26, 2024
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
MEDLINE INDUSTRIES, LP - Northfield

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1876-2024
Recall number
Z-1876-2024
Initiated
February 26, 2024
Classification
Class I
Status
Ongoing
Quantity
168,632 tubes and 13,092 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

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.

Distribution pattern

Distribution was nationwide. There was government/military distributon. Foreign distribution was made to San Salvador and United Arab Emirates.

Field note

Send feedback

We'll only use this to respond to your feedback.