The Recall Desk
Severity pendingFDA (Devices)·Z-0211-2026·Announced 2025-10-29

Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube,

Pending LLM rewrite. Source: FDA_DEVICE Z-0211-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.

The recalled product

Product
Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm 1180264416 Salem Sump" PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 114 cm 1180264424 Salem Sump" PVC Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • 20 Fr/Ch (3.3mm)
  • 108 cm 10192253007015 8888264804 Salem Sump PVC Gastroduodenal Tube
  • 14 Fr/Ch (4.7mm)
  • 108 cm 10192253012422 8888264861 Salem Sump PVC Gastroduodenal Tube
  • 16 Fr/Ch (5.3mm)
  • 108 cm 10192253012439 8888264887 Salem Sump PVC Gastroduodenal Tube
  • 18 Fr/Ch (6.0mm)
  • 108 cm 10192253012446 All Lots

Distribution

Distributed nationwide across the United States.

Related recalls

Same category