The Recall Desk
HighFDA (Devices)·Z-0207-2026·Announced 2025-10-29

[pending] Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12

Pending LLM rewrite. Source: FDA_DEVICE Z-0207-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

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: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 264945 Salem Sump" Stomach Tube, Dual Lumen, 14 Fr/Ch (4.7 mm) 264960 Salem Sump" Stomach Tube, Dual Lumen, 16 Fr/Ch (5.3 mm) 264986 Salem Sump" Stomach Tube, Du
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 (9)

  • Product Code/Product Name/UDI-DI: 264929 Salem Sump" Stomach Tube
  • Dual Lumen
  • 12 Fr/Ch (4.0 mm) 10884521067196 264945 Salem Sump" Stomach Tube
  • 14 Fr/Ch (4.7 mm) 10884521067202 264960 Salem Sump" Stomach Tube
  • 16 Fr/Ch (5.3 mm) 10884521067219 264986 Salem Sump" Stomach Tube
  • 10 Fr/Ch (3.3 mm)
  • 24" (61 cm) 10192253012972 8888268086 Salem Sump" Dual Lumen Stomach Tube
  • 8 Fr/Ch (2.7 mm)
  • 24" (61 cm) 10192253012996 All Lots

Distribution

Distributed nationwide across the United States.

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