# FDA recall Z-0207-2026

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

## 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, Dual Lumen, 18 Fr/Ch (6.0 mm)  5558264957	Salem Sump" COILED TUBE 16Fr/Ch (5.3 mm)  5558264965	Salem Sump" TUBE 16 Fr/Ch (5.3 mm)  5558264973	Salem Sump" COILED TUBE 18Fr/Ch (6.0 mm)  5558264981	Salem Sump" TUBE 18 Fr/Ch 18Fr/Ch (6.0 mm)  8888264911	Salem Sump" Dual Lumen Stomach Tube, 10 Fr/Ch (3.3 mm), 36" (91 cm)  8888268060	Salem Sump" Dual Lumen Stomach Tube 6 Fr/Ch (2.0 mm), 24" (61 cm)  8888268086	Salem Sump" Dual Lumen Stomach Tube, 8 Fr/Ch (2.7 mm), 24" (61 cm)

## 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-0207-2026
- **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-0207-2026

## Citation

> AI Analytics. FDA recall Z-0207-2026. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-0207-2026. Source: US FDA. Licensed CC0.

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