🔍 RecallPedia

Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SALEM SUMP" PVC TUBE 12FR 48IN 8888264945E ENFit" SALEM SUMP" PVC TUBE 14FR 48IN 8888264960E ENFit" Salem Sump" PVC Tube 16Fr 48IN 8888264986E ENFit" SALEM SUMP" PVC TUBE 18FR 48IN 8888266106E PVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN 8888266114E PVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN 8888266122E PVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN 8888266130E PVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN 8888266148E PVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN 8888268060E ENFit" SALEM SUMP" PVC TUBE 6FR 24IN 8888268086E ENFit" Salem Sump" PVC Tube 8Fr 24IN

Class I - Dangerous
🏥 Medical Devices Recalled: September 18, 2025 Cardinal Health 200 Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Product Code/Product Name/UDI-DI: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 10884521779419 8888264929E ENFit" SALEM SUMP" PVC TUBE 12FR 48IN 10884521779426 8888264945E ENFit" SALEM SUMP" PVC TUBE 14FR 48IN 10884521779433 8888264960E ENFit" Salem Sump" PVC Tube 16Fr 48IN 10884521779440 8888264986E ENFit" SALEM SUMP" PVC TUBE 18FR 48IN 10884521779457 8888266106E PVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN 10192253012774 8888266114E PVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN 10192253012798 8888266122E PVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN 10192253012811 8888266130E PVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN 10192253012835 8888266148E PVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN 10192253012859 8888268060E ENFit" SALEM SUMP" PVC TUBE 6FR 24IN 10884521779464 8888268086E ENFit" Salem Sump" PVC Tube 8Fr 24IN 10884521779471 All Lots
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Cardinal Health 200, LLC
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SALEM SUMP" PVC TUBE 12FR 48IN 8888264945E ENFit" SALEM SUMP" PVC TUBE 14FR 48IN 8888264960E ENFit" Salem Sump" PVC Tube 16Fr 48IN 8888264986E ENFit" SALEM SUMP" PVC TUBE 18FR 48IN 8888266106E PVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN 8888266114E PVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN 8888266122E PVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN 8888266130E PVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN 8888266148E PVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN 8888268060E ENFit" SALEM SUMP" PVC TUBE 6FR 24IN 8888268086E ENFit" Salem Sump" PVC Tube 8Fr 24IN

Product Codes/Lot Numbers:

Product Code/Product Name/UDI-DI: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 10884521779419 8888264929E ENFit" SALEM SUMP" PVC TUBE 12FR 48IN 10884521779426 8888264945E ENFit" SALEM SUMP" PVC TUBE 14FR 48IN 10884521779433 8888264960E ENFit" Salem Sump" PVC Tube 16Fr 48IN 10884521779440 8888264986E ENFit" SALEM SUMP" PVC TUBE 18FR 48IN 10884521779457 8888266106E PVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN 10192253012774 8888266114E PVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN 10192253012798 8888266122E PVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN 10192253012811 8888266130E PVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN 10192253012835 8888266148E PVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN 10192253012859 8888268060E ENFit" SALEM SUMP" PVC TUBE 6FR 24IN 10884521779464 8888268086E ENFit" Salem Sump" PVC Tube 8Fr 24IN 10884521779471 All Lots

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0206-2026

Related Recalls

ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile; CT5503T ChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue, Non-sterile; CT5504T ChemoPlus Full Coverage Gown, Closed Back, Extra Large, Medium Blue, Non-sterile; CT5505T ChemoPlus Full Coverage Gown, Closed Back, Extra Extra Large, Medium Blue, Non-sterile; DP5001GT ChemoPlus Full Coverage Gown, Open Back, Large, medium Blue, Non- sterile; DP5002GT ChemoPlus Full Coverage Gown, Open Back, Extra Large, medium Blue, Non-sterile; DP5003GT ChemoPlus Full Coverage Gown, Open Back, Medium, medium Blue, Non-sterile; DP5004GT ChemoPlus Full Coverage Gown, Open Back, Extra Extra Large, medium Blue, Non-sterile; CT5500TS ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Sterile; CT5502TS ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile; CT5503TS ChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue, Sterile; CT5504TS ChemoPlus Full Coverage Gown, Closed Back, Extra Large, Medium Blue, Sterile; CT5505TS ChemoPlus Full Coverage Gown, Closed Back, Extra Extra Large, Medium Blue, Sterile;

Cardinal Health 200

Class I - Dangerous

Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.

Nov 12, 2025 Infusion Pumps Nationwide View Details →

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 TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 16 Fr/Ch (5.3 mm) x 48 (122 cm) 8888266288 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 18 Fr/Ch (6.0 mm) x 48 (122 cm)

Cardinal Health 200

Class I - Dangerous

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.

Sep 18, 2025 Other Medical Devices Nationwide View Details →

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)

Cardinal Health 200

Class I - Dangerous

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.

Sep 18, 2025 Other Medical Devices Nationwide View Details →