Salem Sump Tubes and Anti-Reflux Valves Recalled for Breakage Risk

Agency Publication Date: October 17, 2025

Summary

Cardinal Health 200, LLC is recalling all lots of Salem Sump PVC and Silicone Tubes and standalone Anti-Reflux Valves. This recall expansion follows reports that the Anti-Reflux Valve (ARV) may break if excessive force is applied during clinical use. The company is providing additional guidance for the correct use and handling of these tubes and valves to prevent failure.

Risk

If the anti-reflux valve breaks during use, it can cause the stomach tube to stop functioning correctly or lead to clinical complications. There is also a risk that broken valve pieces could cause injury or be inhaled by the patient.

What You Should Do

This recall affects multiple varieties of Salem Sump and ENFit stomach tubes, gastroduodenal tubes, and standalone anti-reflux valves sold under the Cardinal Health brand.
Identify if your product is affected by checking the model number and UDI-DI on the device labeling or packaging. This recall applies to all lots of the listed products. See the Affected Products section below for the full list of affected codes.
Stop using the recalled devices immediately. Contact Cardinal Health 200, LLC or your medical equipment distributor to arrange for a return, replacement, or to receive updated clinical guidance for safe use.
If you have questions about the recall or how to handle affected stock, contact Cardinal Health 200, LLC directly.
For additional information, call the FDA Consumer Complaint hotline at 1-888-463-6332.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: ENFit SALEM SUMP PVC TUBE 10FR 36IN

Model / REF:

8888264911E

Lot Numbers:

All Lots

UDI:

10884521779419

Product: ENFit SALEM SUMP PVC TUBE 12FR 48IN

Model / REF:

8888264929E

Lot Numbers:

All Lots

UDI:

10884521779426

Product: ENFit SALEM SUMP PVC TUBE 14FR 48IN

Model / REF:

8888264945E

Lot Numbers:

All Lots

UDI:

10884521779433

Product: ENFit Salem Sump PVC Tube 16Fr 48IN

Model / REF:

8888264960E

Lot Numbers:

All Lots

UDI:

10884521779440

Product: ENFit SALEM SUMP PVC TUBE 18FR 48IN

Model / REF:

8888264986E

Lot Numbers:

All Lots

UDI:

10884521779457

Product: PVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN

Model / REF:

8888266106E

Lot Numbers:

All Lots

UDI:

10192253012774

Product: PVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN

Model / REF:

8888266114E

Lot Numbers:

All Lots

UDI:

10192253012798

Product: PVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN

Model / REF:

8888266122E

Lot Numbers:

All Lots

UDI:

10192253012811

Product: PVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN

Model / REF:

8888266130E

Lot Numbers:

All Lots

UDI:

10192253012835

Product: PVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN

Model / REF:

8888266148E

Lot Numbers:

All Lots

UDI:

10192253012859

Product: ENFit SALEM SUMP PVC TUBE 6FR 24IN

Model / REF:

8888268060E

Lot Numbers:

All Lots

UDI:

10884521779464

Product: ENFit Salem Sump PVC Tube 8Fr 24IN

Model / REF:

8888268086E

Lot Numbers:

All Lots

UDI:

10884521779471

Product: Salem Sump Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm)

Model / REF:

264929

Lot Numbers:

All Lots

UDI:

10884521067196

Product: Salem Sump Stomach Tube, Dual Lumen, 14 Fr/Ch (4.7 mm)

Model / REF:

264945

Lot Numbers:

All Lots

UDI:

10884521067202

Product: Salem Sump Stomach Tube, Dual Lumen, 16 Fr/Ch (5.3 mm)

Model / REF:

264960

Lot Numbers:

All Lots

UDI:

10884521067219

Product: Salem Sump Stomach Tube, Dual Lumen, 18 Fr/Ch (6.0 mm)

Model / REF:

264986

Lot Numbers:

All Lots

UDI:

10884521067226

Product: Salem Sump COILED TUBE 16Fr/Ch (5.3 mm)

Model / REF:

5558264957

Lot Numbers:

All Lots

UDI:

50192253008171

Product: Salem Sump TUBE 16 Fr/Ch (5.3 mm)

Model / REF:

5558264965

Lot Numbers:

All Lots

UDI:

50192253008195

Product: Salem Sump COILED TUBE 18Fr/Ch (6.0 mm)

Model / REF:

5558264973

Lot Numbers:

All Lots

UDI:

50192253008201

Product: Salem Sump TUBE 18 Fr/Ch 18Fr/Ch (6.0 mm)

Model / REF:

5558264981

Lot Numbers:

All Lots

UDI:

50192253008218

Product: Salem Sump Dual Lumen Stomach Tube, 10 Fr/Ch (3.3 mm), 36" (91 cm)

Model / REF:

8888264911

Lot Numbers:

All Lots

UDI:

10192253012453

Product: Salem Sump Dual Lumen Stomach Tube 6 Fr/Ch (2.0 mm), 24" (61 cm)

Model / REF:

8888268060

Lot Numbers:

All Lots

UDI:

10192253012972

Product: Salem Sump Dual Lumen Stomach Tube, 8 Fr/Ch (2.7 mm), 24" (61 cm)

Model / REF:

8888268086

Lot Numbers:

All Lots

UDI:

10192253012996

Product: Salem Sump Silicone Dual Lumen Stomach Tube, 10 Fr/Ch, 36 (91 cm)

Model / REF:

8888265108

Lot Numbers:

All Lots

UDI:

10884521000766

Product: Salem Sump Silicone Dual Lumen Stomach Tube, 12 Fr/Ch, 48 (122 cm)

Model / REF:

8888265116

Lot Numbers:

All Lots

UDI:

10884521020078

Product: Salem Sump Silicone Dual Lumen Stomach Tube, 14 Fr/Ch, 48 (122 cm)

Model / REF:

8888265124

Lot Numbers:

All Lots

UDI:

10884521020085

Product: Salem Sump Silicone Dual Lumen Stomach Tube, 16 Fr/Ch, 48 (122 cm)

Model / REF:

8888265132

Lot Numbers:

All Lots

UDI:

10884521020092

Product: Salem Sump Silicone Dual Lumen Stomach Tube, 18 Fr/Ch, 48 (122 cm)

Model / REF:

8888265140

Lot Numbers:

All Lots

UDI:

10884521020108

Product: Salem Sump Silicone Dual Lumen Stomach Tube with ARV, 10 Fr/Ch

Model / REF:

8888266213

Lot Numbers:

All Lots

UDI:

10192253012781

Product: Salem Sump Silicone Dual Lumen Stomach Tube with ARV, 12 Fr/Ch

Model / REF:

8888266221

Lot Numbers:

All Lots

UDI:

10884521000803

Product: Salem Sump Silicone Dual Lumen Stomach Tube with ARV, 14 Fr/Ch

Model / REF:

8888266247

Lot Numbers:

All Lots

UDI:

10884521000827

Product: Salem Sump Silicone Dual Lumen Stomach Tube with ARV, 16 Fr/Ch

Model / REF:

8888266262

Lot Numbers:

All Lots

UDI:

10884521000841

Product: Salem Sump Silicone Dual Lumen Stomach Tube with ARV, 18 Fr/Ch

Model / REF:

8888266288

Lot Numbers:

All Lots

UDI:

10884521000858

Product: Salem Sump Anti-Reflux Valve CE Marked

Model / REF:

266197

Lot Numbers:

All Lots

UDI:

10884527022762

Product: Salem Sump Anti-Reflux Valve

Model / REF:

8888266197

Lot Numbers:

All Lots

UDI:

10192253012866

Product: Salem Sump Stomach Tube with ARV, 14 Fr/Ch (4.7 mm)

Model / REF:

266122

Lot Numbers:

All Lots

UDI:

10884521065024

Product: Salem Sump Stomach Tube with ARV, 16 Fr/Ch (5.3 mm)

Model / REF:

266130

Lot Numbers:

All Lots

UDI:

10884521065031

Product: Salem Sump Stomach Tube with ARV, 18 Fr/Ch

Model / REF:

266148

Lot Numbers:

All Lots

UDI:

10884521065055

Product: Salem Sump Dual Lumen Stomach Tube with ARV, 10Fr/Ch (3.3 mm), 36"

Model / REF:

8888266106

Lot Numbers:

All Lots

UDI:

20884521004655

Product: Salem Sump Tube 16FR with CONFIRM NOW

Model / REF:

266130CN

Lot Numbers:

All Lots

UDI:

10884521141292

Product: Salem Sump Tube 8 FR with CONFIRM NOW

Model / REF:

266148CN

Lot Numbers:

All Lots

UDI:

20884521141305

Product: Salem Sump PVC Gastroduodenal Tube, 10 Fr/Ch x 90 cm

Model / REF:

1180264408

Lot Numbers:

All Lots

UDI:

10192253006940

Product: Salem Sump PVC Gastroduodenal Tube, 12 Fr/Ch x 114 cm

Model / REF:

1180264416

Lot Numbers:

All Lots

UDI:

10192253006957

Product: Salem Sump PVC Gastroduodenal Tube, 14 Fr/Ch x 114 cm

Model / REF:

1180264424

Lot Numbers:

All Lots

UDI:

10192253006964

Product: Salem Sump PVC Gastroduodenal Tube, 16 Fr/Ch x 114 cm

Model / REF:

1180264432

Lot Numbers:

All Lots

UDI:

10192253006971

Product: Salem Sump PVC Gastroduodenal Tube, 18 Fr/Ch x 114 cm

Model / REF:

1180264440

Lot Numbers:

All Lots

UDI:

10192253007053

Product: Salem Sump PVC Gastroduodenal Tube, 20 Fr/Ch x 114 cm

Model / REF:

1180264457

Lot Numbers:

All Lots

UDI:

10192253006568

Product: Salem Sump Polyurethane Gastroduodenal Tube, 14 Fr/Ch x 114 cm

Model / REF:

1180264523

Lot Numbers:

All Lots

UDI:

10192253007060

Product: Salem Sump Polyurethane Gastroduodenal Tube, 16 Fr/Ch x 114 cm

Model / REF:

1180264531

Lot Numbers:

All Lots

UDI:

10192253006988

Product: Salem Sump Polyurethane Gastroduodenal Tube, 18 Fr/Ch x 114 cm

Model / REF:

1180264549

Lot Numbers:

All Lots

UDI:

10192253006995

Product: Salem Sump Polyurethane Gastroduodenal Tube, 20 Fr/Ch x 114 cm

Model / REF:

1180264556

Lot Numbers:

All Lots

UDI:

10192253007008

Product: Salem Sump PVC Gastroduodenal Tube, 20 Fr/Ch, 108 cm

Model / REF:

1180264895

Lot Numbers:

All Lots

UDI:

10192253007015

Product: Salem Sump PVC Gastroduodenal Tube, 10Fr/Ch x 85 cm

Model / REF:

8888264804

Lot Numbers:

All Lots

UDI:

10192253012408

Product: Salem Sump PVC Gastroduodenal Tube, 12 Fr/Ch x 108 cm

Model / REF:

8888264820

Lot Numbers:

All Lots

UDI:

10192253012415

Product: Salem Sump PVC Gastroduodenal Tube, 14 Fr/Ch, 108 cm

Model / REF:

8888264846

Lot Numbers:

All Lots

UDI:

10192253012422

Product: Salem Sump PVC Gastroduodenal Tube, 16 Fr/Ch, 108 cm

Model / REF:

8888264861

Lot Numbers:

All Lots

UDI:

10192253012439

Product: Salem Sump PVC Gastroduodenal Tube, 18 Fr/Ch, 108 cm

Model / REF:

8888264887

Lot Numbers:

All Lots

UDI:

10192253012446

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97539

Status: Active

Manufacturer: Cardinal Health 200, LLC

Sold By: Hospitals; Medical Supply Distributors; Clinical Facilities

Manufactured In: United States

Units Affected: 6 products (all lots; all lots; all lots; all lots; all lots; all lots)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects multiple varieties of Salem Sump and ENFit stomach tubes, gastroduodenal tubes, and standalone anti-reflux valves sold under the Cardinal Health brand.

Identify if your product is affected by checking the model number and UDI-DI on the device labeling or packaging. This recall applies to all lots of the listed products. See the Affected Products section below for the full list of affected codes.

Stop using the recalled devices immediately. Contact Cardinal Health 200, LLC or your medical equipment distributor to arrange for a return, replacement, or to receive updated clinical guidance for safe use.

If you have questions about the recall or how to handle affected stock, contact Cardinal Health 200, LLC directly.

For additional information, call the FDA Consumer Complaint hotline at 1-888-463-6332.

Affected Products

Product: ENFit SALEM SUMP PVC TUBE 10FR 36IN

Model / REF:

8888264911E

Lot Numbers:

All Lots

UDI:

10884521779419

Product: ENFit SALEM SUMP PVC TUBE 12FR 48IN

Model / REF:

8888264929E

Lot Numbers:

All Lots

UDI:

10884521779426

Product: ENFit SALEM SUMP PVC TUBE 14FR 48IN

Model / REF:

8888264945E

Lot Numbers:

All Lots

UDI:

10884521779433

Product: ENFit Salem Sump PVC Tube 16Fr 48IN

Model / REF:

8888264960E

Lot Numbers:

All Lots

UDI:

10884521779440

Product: ENFit SALEM SUMP PVC TUBE 18FR 48IN

Model / REF:

8888264986E

Lot Numbers:

All Lots

UDI:

10884521779457

Product: PVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN

Model / REF:

8888266106E

Lot Numbers:

All Lots

UDI:

10192253012774

Product: PVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN

Model / REF:

8888266114E

Lot Numbers:

All Lots

UDI:

10192253012798

Product: PVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN

Model / REF:

8888266122E

Lot Numbers:

All Lots

UDI:

10192253012811

Product: PVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN

Model / REF:

8888266130E

Lot Numbers:

All Lots

UDI:

10192253012835

Product: PVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN

Model / REF:

8888266148E

Lot Numbers:

All Lots

UDI:

10192253012859

Product: ENFit SALEM SUMP PVC TUBE 6FR 24IN

Model / REF:

8888268060E

Lot Numbers:

All Lots

UDI:

10884521779464

Product: ENFit Salem Sump PVC Tube 8Fr 24IN

Model / REF:

8888268086E

Lot Numbers:

All Lots

UDI:

10884521779471

Product: Salem Sump Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm)

Model / REF:

264929

Lot Numbers:

All Lots

UDI:

10884521067196

Product: Salem Sump Stomach Tube, Dual Lumen, 14 Fr/Ch (4.7 mm)

Model / REF:

264945

Lot Numbers:

All Lots

UDI:

10884521067202

Product: Salem Sump Stomach Tube, Dual Lumen, 16 Fr/Ch (5.3 mm)

Model / REF:

264960

Lot Numbers:

All Lots

UDI:

10884521067219

Product: Salem Sump Stomach Tube, Dual Lumen, 18 Fr/Ch (6.0 mm)

Model / REF:

264986

Lot Numbers:

All Lots

UDI:

10884521067226

Product: Salem Sump COILED TUBE 16Fr/Ch (5.3 mm)

Model / REF:

5558264957

Lot Numbers:

All Lots

UDI:

50192253008171

Product: Salem Sump TUBE 16 Fr/Ch (5.3 mm)

Model / REF:

5558264965

Lot Numbers:

All Lots

UDI:

50192253008195

Product: Salem Sump COILED TUBE 18Fr/Ch (6.0 mm)

Model / REF:

5558264973

Lot Numbers:

All Lots

UDI:

50192253008201

Product: Salem Sump TUBE 18 Fr/Ch 18Fr/Ch (6.0 mm)

Model / REF:

5558264981

Lot Numbers:

All Lots

UDI:

50192253008218

Product: Salem Sump Dual Lumen Stomach Tube, 10 Fr/Ch (3.3 mm), 36" (91 cm)

Model / REF:

8888264911

Lot Numbers:

All Lots

UDI:

10192253012453

Product: Salem Sump Dual Lumen Stomach Tube 6 Fr/Ch (2.0 mm), 24" (61 cm)

Model / REF:

8888268060

Lot Numbers:

All Lots

UDI:

10192253012972

Product: Salem Sump Dual Lumen Stomach Tube, 8 Fr/Ch (2.7 mm), 24" (61 cm)

Model / REF:

8888268086

Lot Numbers:

All Lots

UDI:

10192253012996

Product: Salem Sump Silicone Dual Lumen Stomach Tube, 10 Fr/Ch, 36 (91 cm)

Model / REF:

8888265108

Lot Numbers:

All Lots

UDI:

10884521000766

Product: Salem Sump Silicone Dual Lumen Stomach Tube, 12 Fr/Ch, 48 (122 cm)

Model / REF:

8888265116

Lot Numbers:

All Lots

UDI:

10884521020078

Product: Salem Sump Silicone Dual Lumen Stomach Tube, 14 Fr/Ch, 48 (122 cm)

Model / REF:

8888265124

Lot Numbers:

All Lots

UDI:

10884521020085

Product: Salem Sump Silicone Dual Lumen Stomach Tube, 16 Fr/Ch, 48 (122 cm)

Model / REF:

8888265132

Lot Numbers:

All Lots

UDI:

10884521020092

Product: Salem Sump Silicone Dual Lumen Stomach Tube, 18 Fr/Ch, 48 (122 cm)

Model / REF:

8888265140

Lot Numbers:

All Lots

UDI:

10884521020108

Product: Salem Sump Silicone Dual Lumen Stomach Tube with ARV, 10 Fr/Ch

Model / REF:

8888266213

Lot Numbers:

All Lots

UDI:

10192253012781

Product: Salem Sump Silicone Dual Lumen Stomach Tube with ARV, 12 Fr/Ch

Model / REF:

8888266221

Lot Numbers:

All Lots

UDI:

10884521000803

Product: Salem Sump Silicone Dual Lumen Stomach Tube with ARV, 14 Fr/Ch

Model / REF:

8888266247

Lot Numbers:

All Lots

UDI:

10884521000827

Product: Salem Sump Silicone Dual Lumen Stomach Tube with ARV, 16 Fr/Ch

Model / REF:

8888266262

Lot Numbers:

All Lots

UDI:

10884521000841

Product: Salem Sump Silicone Dual Lumen Stomach Tube with ARV, 18 Fr/Ch

Model / REF:

8888266288

Lot Numbers:

All Lots

UDI:

10884521000858

Product: Salem Sump Anti-Reflux Valve CE Marked

Model / REF:

266197

Lot Numbers:

All Lots

UDI:

10884527022762

Product: Salem Sump Anti-Reflux Valve

Model / REF:

8888266197

Lot Numbers:

All Lots

UDI:

10192253012866

Product: Salem Sump Stomach Tube with ARV, 14 Fr/Ch (4.7 mm)

Model / REF:

266122

Lot Numbers:

All Lots

UDI:

10884521065024

Product: Salem Sump Stomach Tube with ARV, 16 Fr/Ch (5.3 mm)

Model / REF:

266130

Lot Numbers:

All Lots

UDI:

10884521065031

Product: Salem Sump Stomach Tube with ARV, 18 Fr/Ch

Model / REF:

266148

Lot Numbers:

All Lots

UDI:

10884521065055

Product: Salem Sump Dual Lumen Stomach Tube with ARV, 10Fr/Ch (3.3 mm), 36"

Model / REF:

8888266106

Lot Numbers:

All Lots

UDI:

20884521004655

Product: Salem Sump Tube 16FR with CONFIRM NOW

Model / REF:

266130CN

Lot Numbers:

All Lots

UDI:

10884521141292

Product: Salem Sump Tube 8 FR with CONFIRM NOW

Model / REF:

266148CN

Lot Numbers:

All Lots

UDI:

20884521141305

Product: Salem Sump PVC Gastroduodenal Tube, 10 Fr/Ch x 90 cm

Model / REF:

1180264408

Lot Numbers:

All Lots

UDI:

10192253006940

Product: Salem Sump PVC Gastroduodenal Tube, 12 Fr/Ch x 114 cm

Model / REF:

1180264416

Lot Numbers:

All Lots

UDI:

10192253006957

Product: Salem Sump PVC Gastroduodenal Tube, 14 Fr/Ch x 114 cm

Model / REF:

1180264424

Lot Numbers:

All Lots

UDI:

10192253006964

Product: Salem Sump PVC Gastroduodenal Tube, 16 Fr/Ch x 114 cm

Model / REF:

1180264432

Lot Numbers:

All Lots

UDI:

10192253006971

Product: Salem Sump PVC Gastroduodenal Tube, 18 Fr/Ch x 114 cm

Model / REF:

1180264440

Lot Numbers:

All Lots

UDI:

10192253007053

Product: Salem Sump PVC Gastroduodenal Tube, 20 Fr/Ch x 114 cm

Model / REF:

1180264457

Lot Numbers:

All Lots

UDI:

10192253006568

Product: Salem Sump Polyurethane Gastroduodenal Tube, 14 Fr/Ch x 114 cm

Model / REF:

1180264523

Lot Numbers:

All Lots

UDI:

10192253007060

Product: Salem Sump Polyurethane Gastroduodenal Tube, 16 Fr/Ch x 114 cm

Model / REF:

1180264531

Lot Numbers:

All Lots

UDI:

10192253006988

Product: Salem Sump Polyurethane Gastroduodenal Tube, 18 Fr/Ch x 114 cm

Model / REF:

1180264549

Lot Numbers:

All Lots

UDI:

10192253006995

Product: Salem Sump Polyurethane Gastroduodenal Tube, 20 Fr/Ch x 114 cm

Model / REF:

1180264556

Lot Numbers:

All Lots

UDI:

10192253007008

Product: Salem Sump PVC Gastroduodenal Tube, 20 Fr/Ch, 108 cm

Model / REF:

1180264895

Lot Numbers:

All Lots

UDI:

10192253007015

Product: Salem Sump PVC Gastroduodenal Tube, 10Fr/Ch x 85 cm

Model / REF:

8888264804

Lot Numbers:

All Lots

UDI:

10192253012408

Product: Salem Sump PVC Gastroduodenal Tube, 12 Fr/Ch x 108 cm

Model / REF:

8888264820

Lot Numbers:

All Lots

UDI:

10192253012415

Product: Salem Sump PVC Gastroduodenal Tube, 14 Fr/Ch, 108 cm

Model / REF:

8888264846

Lot Numbers:

All Lots

UDI:

10192253012422

Product: Salem Sump PVC Gastroduodenal Tube, 16 Fr/Ch, 108 cm

Model / REF:

8888264861

Lot Numbers:

All Lots

UDI:

10192253012439

Product: Salem Sump PVC Gastroduodenal Tube, 18 Fr/Ch, 108 cm

Model / REF:

8888264887

Lot Numbers:

All Lots

UDI:

10192253012446

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97539

Status: Active

Manufacturer: Cardinal Health 200, LLC

Sold By: Hospitals; Medical Supply Distributors; Clinical Facilities

Manufactured In: United States

Units Affected: 6 products (all lots; all lots; all lots; all lots; all lots; all lots)

Distributed To: Nationwide