# FDA recall Z-0208-2026

> **Cardinal Health 200, LLC** · Class II · device recall initiated 2025-09-18.

## 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	Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 14 Fr/Ch (4.7 mm), 48  (122 cm)  8888265132	Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 16 Fr/Ch (5.3 mm), 48  (122 cm)  8888265140	Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 18 Fr/Ch (6.0 mm), 48  (122 cm)  8888266213	Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 10 Fr/Ch (3.3 mm) x 36  (91 cm)  8888266221	Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 12 Fr/Ch (4.0 mm) x 48  (122 cm)  8888266247	Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 14 Fr/Ch (4.7 mm) x 48  (122 cm)  8888266262	Salem Sump T

## Reason for recall

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.

## Distribution

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR, GU and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Africa, Kuwait, Luxembourg, Mexico Monaco, Netherlands, New Zealand, Northern Ireland, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Taiwan, UAE, United Kingdom, Vietnam.

## Key facts

- **Recall number:** Z-0208-2026
- **Recalling firm:** Cardinal Health 200, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-18
- **Report date:** 2025-10-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukegan, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0208-2026

## Citation

> AI Analytics. FDA recall Z-0208-2026. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0208-2026. Source: US FDA. Licensed CC0.

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