Agency classClass IIOur severity:High FDA (Devices)·Z-0208-2026·Announced 2025-10-29

Silicone stomach tubes recalled after anti-reflux valve breakage complaints

Cardinal Health is recalling all lots of Salem Sump silicone dual lumen stomach tubes after complaints of anti-reflux valve breakage due to excessive force during use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: Scored 3 under the risk-of-harm criterion: complaints report valve breakage during use of a gastric tube, and no injuries are reported.

Plain-English summary

Salem Sump PVC Tubes are being recalled, covering the Salem Sump Silicone Dual Lumen Stomach Tube with radiopaque line in 10 Fr/Ch x 36 in (product code 8888265108), 12 Fr/Ch (8888265116) and other sizes.

The firm has received complaints regarding Anti-Reflux Valve breakage due to excessive force during use, and is providing additional guidance for use. The record notes this is an expansion of an earlier action, RES 95214.

The recall covers all lots, distributed worldwide including nationwide in the United States. The FDA has classified the action as Class II.

The enforcement record describes the breakage complaints and reports no injuries. Facilities should follow Cardinal Health's updated guidance for use.

The recalled product

Product: Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3 mm), 36 (91 cm) 8888265116 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 12 Fr/Ch (4.0 mm), 48 (122 cm) 8888265124…
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Gastric tube
Hazard: component-breakage
excessive-force
recall-expansion

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)

Radiopaque Line
10 Fr/Ch (3.3 mm)
12 Fr/Ch (4.0 mm)
14 Fr/Ch (4.7 mm)
16 Fr/Ch (5.3 mm)
18 Fr/Ch (6.0 mm)
Anti-Reflux Valve and Radiopaque Line
18 Fr/Ch (6.0 mm) x 48 (122 cm) 10884521000858 All Lots

Distribution

Distributed nationwide across the United States.

The notice also names 53 states specifically:

Part of a larger recall action

This product is one of 6 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Same manufacturer · Cardinal Health 200, LLC

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Same hazard · component breakage