Salem SumpRecalls & reported problems across all models
Cardinal Health, Inc. · 28 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
3 open recalls name at least one Salem Sump model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 92
- Deaths reported
- 1
- Injuries reported
- 8
- Recalls
- 3
We found 28 models of Salem Sump by Cardinal Health, Inc. in the FDA's device registry (GUDID). Together they are named in 92 adverse event reports in the FDA's MAUDE database, received between Mar 15, 2017 and Aug 15, 2025 — classified as 1 death, 8 injuries, 83 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (26 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Salem Sump recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 18, 2025Class IIOpen, Classified
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.
Z-0210-2026 · Root cause: Use error · names 2 of these models · Recall details · FDA record ↗
- Sep 18, 2025Class IIOpen, Classified
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.
Z-0208-2026 · Root cause: Use error · names 9 of these models · Recall details · FDA record ↗
- Sep 18, 2025Class IIOpen, Classified
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.
Z-0207-2026 · Root cause: Use error · Recall details · FDA record ↗
Most reported Salem Sump problems
Device problems
- Fluid/Blood Leak26
- Break14
- Suction Problem13
- Crack9
- Detachment of Device or Device Component7
- Material Separation7
- Obstruction of Flow7
- Decrease in Suction5
Patient problems
- No Clinical Signs, Symptoms or Conditions31
- No Consequences Or Impact To Patient23
- No Known Impact Or Consequence To Patient10
- Insufficient Information5
- Aspiration/Inhalation4
- Discomfort4
- Vomiting4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
Salem Sump models
28 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Salem Sump 8888265132TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall2 reports
- Salem Sump 8888265108TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall0 reports
- Salem Sump 8888266221TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall0 reports
- Salem Sump 8888266247TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall0 reports
- Salem Sump 8888266262TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall0 reports
- Salem Sump 8888266288TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall0 reports
- Salem Sump 8888265116TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall0 reports
- Salem Sump 8888265124TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall0 reports
- Salem Sump 8888265140TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall0 reports
- Salem Sump 264960Tubes, Gastrointestinal (And Accessories)1 recall0 reports
- Salem Sump 266130CNTUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION1 recall0 reports
- Salem Sump 266148CNTUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION1 recall0 reports
- Salem Sump 7771810EGastrointestinal Tubes with Enteral Specific Connectors28 reports
- Salem Sump 7771610EGastrointestinal Tubes with Enteral Specific Connectors1 death18 reports
- Salem Sump 8888266197TUBES, GASTROINTESTINAL (AND ACCESSORIES)9 reports
- Salem Sump 8888266130TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION8 reports
- Salem Sump 8888266148TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION5 reports
- Salem Sump 7771810TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION4 reports
- Salem Sump 8888264945TUBES, GASTROINTESTINAL (AND ACCESSORIES)4 reports
- Salem Sump 7771410EGastrointestinal Tubes with Enteral Specific Connectors3 reports
- Salem Sump 8888264911TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 reports
- Salem Sump 8888264986TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 reports
- Salem Sump 8888268060TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 reports
- Salem Sump 7771210TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION1 report
- Salem Sump 8888266122TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION1 report
- Salem Sump 8888264929TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 report
- Salem Sump 8888264960TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 report
- Salem Sump 8888268086TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 report
Recent Salem Sump adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 15, 2025Break; Break
THE CUSTOMER REPORTED THAT THE SALEM SUMP ANTI-REFLUX VALVE SNAPPED IN HALF WHILE IN PATIENTS' NG TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22818193 ↗MalfunctionAug 14, 2025Break; Break
THE CUSTOMER REPORTED THAT THE PATIENT HAS NASOGASTRIC TUBE TO LOW-INTERMITTENT SUCTION. PATIENT'S NG TUBE WAS CLAMPED FOLLOWING LIQUID PO TYLENOL ADMINISTRATION. NG TUBE WAS CLAMPED USING "SALEM SUMP ANTI-REFLUX VALVE" PIECE. WHEN DISCONNECTING PIECE FROM NG TUBE TO RETURN TO SUCTION, WHITE PART OF "SALEM SUMP ANTI-REFLUX VALVE" BROKE AND BECAME LODGED INTO NG TUBE, COMPLETELY BLOCKING TUBE. PIECE WAS ABLE TO BE REMOVED AFTER 15MIN OF ATTEMPTING TO DISLODGE PIECE. NG RETURNED TO LIS WITHOUT ANY FURTHER ISSUE FOLLOWING REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22812398 ↗MalfunctionMay 29, 2025Break; Break
THE CUSTOMER REPORTED THAT THE WRITER WENT TO UNCLAMP THE SALEM SUMP NASOGASTRIC TUBE (NG) AS IT HAD BEEN 30 MINUTES SINCE THE ADMINISTRATION OF MEDICATION. PER CUSTOMER, THE ANTI-REFLUX VALVE BROKE OFF INSIDE THE DISTAL END OF THE SALEM SUMP. THE WRITER AND ANOTHER NURSE ATTEMPTED TO REMOVE IT BY HAND AND WITH A CLAMP, BUT THE BROKEN END KEPT BREAKING OFF SMALL PIECES OF THE PLASTIC. THE WRITER WAS ABLE TO CUT THE DISTAL PORTION OFF, PRESERVING THE TUBE AND ITS FUNCTION AND RECONNECT THE PATIENT TO LOW CONTINUOUS SUCTION. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22107640 ↗MalfunctionMar 12, 2025Break; Separation Failure; Break; Separation Failure
THE CUSTOMER REPORTED THE PATIENT ARRIVED AT MEDICAL SURGERY UNIT WITH NG [NASO-GASTRIC TUBE] CAPPED WITH VENTILATION CAP FROM ED [EMERGENCY DEPARTMENT]. RN [REGISTERED NURSE] WENT TO REMOVE VENT CAP/PLUG TO HOOK PATIENT UP TO SUCTION, AND NG PLUG WAS STUCK AND WOULD NOT COME OUT. BOTH SIDES INSERTED WERE STUCK (BLUE AND WHITE) THE BLUE PLUG WAS IN THE BLUE TUBE, AND THE WHITE PLUG WAS IN THE CLEAR MAIN PORT. RN TRIED TO REMOVE, AND THE BLUE END SNAPPED AND BROKE IN THE TUBE. SECOND RN ATTEMPTED TO REMOVE AND COULD NOT. MANAGER BROUGHT IN AND THEY TRIED TO REMOVE WITH KELLY CLAMP AND WERE UNSUCCESSFUL. THEY CUT THE TUBING BELOW BOTH CAPS TO STILL UTILIZE THE PRODUCT, SO THEY DIDN'T HAVE TO REMOVE THE ITEM FROM THE PATIENT AND REPLACE. THE PATIENT DID STATE IF THE PRODUCT WAS REMOVED, SHE DID NOT WANT IT PLACED BACK AGAIN BECAUSE THE INSERTION IS NOT COMFORTABLE TO HER. OUTWEIGHED THE RISK VS BENEFITS AND FOUND NO RISK IN CUTTING THE TUBING BELOW THE STUCK CAPS. THEY WERE ABLE TO RE-HOOK UP SUCTION AND RECAP THE BLUE PORT WITH A NEW VENT CAP AFTER REMOVING THE STUCK CAPS. SUCTION WAS SUCCESSFULLY RESTARTED, AND PATIENT CARE WAS BACK TO NORMAL. THIS PRODUCT IS FAILING AND IS NOT USER
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21586077 ↗MalfunctionJan 8, 2025Break; Break
THE CUSTOMER REPORTED WHEN USING THE ANTI-REFLUX VALVE WITH THE NG TUBE, IT IS BREAKING WHEN THEY ATTEMPT TO REMOVE IT FROM THE TUBE. THEY HAVE HAD THIS HAPPEN MULTIPLE TIMES NOW SO THEY ARE THINKING IT MAY BE A PRODUCT ISSUE INSTEAD OF A USER/FLUKE THING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21105995 ↗MalfunctionOct 8, 2024Material Separation; Material Separation
THE CUSTOMER REPORTED THAT HE TESTED THE DEVICE BY HAND TO SEE HOW EASILY THE TIP CAN COME OFF AND IT CAME OFF BUT NOT AS EASILY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20397399 ↗MalfunctionOct 8, 2024Material Separation; Material Separation
THE CUSTOMER REPORTED THAT HE TESTED THE DEVICE BY HAND TO SEE HOW EASILY THE TIP CAN COME OFF AND IT CAME OFF BUT NOT AS EASILY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20397268 ↗MalfunctionOct 8, 2024Material Separation; Material Separation
THE CUSTOMER REPORTED THAT THE TIP OF THE COVIDIEN SALEM SUMP POPPED RIGHT OFF. ADDITIONAL INFORMATION RECEIVED ON 14SEP2023 STATED THAT THE INCIDENT OCCURRED PRIOR TO PATIENT INSERTION. THE DOCTOR NOTICED THE TIP WAS BENT AND IT SNAPPED OFF WHEN STRAIGHTENING THE TIP. THE TIP DID NOT ENTER THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20397257 ↗MalfunctionMay 26, 2024Break; Break
THE CUSTOMER REPORTED THAT THE ARV BROKE WHEN TRYING TO REMOVE IT FROM THE SALEM SUMP - THE PART THAT WAS IN THE SUMP STAYED IN, AND THE PART OUT, BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19398947 ↗MalfunctionApr 29, 2024Break; Break
THE CUSTOMER REPORTED THE BLUE END BROKE OFF FOR SEEMINGLY NO REASON PER STAFF NURSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19200848 ↗MalfunctionApr 29, 2024Break; Break
THE CUSTOMER REPORTED THE BLUE END BROKE OFF THE ARV FOR SEEMINGLY NO REASON (PER THE STAFF NURSE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19200778 ↗InjuryMar 28, 2024Break; Break
PER CUSTOMER, THE INCIDENT IN QUESTION INVOLVED A 78-YEAR-OLD PATIENT WHO HAD AN NG (NASOGASTRIC) TUBE PLACED FOR MEDICAL REASONS. A SMALL BOWEL FOLLOW-THROUGH (SBFT) TEST WAS SCHEDULED FOR THE MORNING, REQUIRING THE NG TUBE TO BE TEMPORARILY CLAMPED. TO ACHIEVE THIS, THE BLUE/WHITE FILTER WAS INSERTED INTO THE OPEN END OF THE NG TUBE AS A PLUG. HOWEVER, WHEN IT WAS TIME TO RECONNECT THE PATIENT TO WALL SUCTION, THE FILTER BROKE IN HALF AND BECAME LODGED INSIDE THE NG TUBE. EFFORTS WERE MADE BY BOTH A REGISTERED NURSE (RN) AND THE CHARGE NURSE TO REMOVE THE STUCK FILTER, BUT THESE ATTEMPTS WERE UNSUCCESSFUL. MULTIPLE TOOLS WERE EMPLOYED IN THE ATTEMPT TO DISLODGE THE FILTER, BUT THEY PROVED INEFFECTIVE. THE CUSTOMER FURTHER EXPLAINED THAT THE BLUE PART WAS SEATED IN THE MAIN LUMEN. THIS IS WHAT THE PRODUCT DESCRIPTION STATES TO DO TO PLUG THE SYSTEM WHEN NOT IN USE. WHERE THE VENT ATTACHES TO THE BLUE PART IS WHERE THE ITEM SNAPPED OFF COMPLETELY. WHEN ATTEMPTING TO REMOVE IT, ENOUGH FORCE WAS USED TO TRY AND PRY THE ITEM OUT. THE CUSTOMER WAS TOLD THE NURSE WAS TRYING TO TWIST AND TURN IT OUT AS WELL WITH NO SUCCESS. IT WAS STUCK INITIALLY WHEN REMOVAL WAS ATTEMPTED. SINCE THE NG
Patient problems: Aspiration/Inhalation; Discomfort; Epistaxis
MAUDE report 18998195 ↗MalfunctionFeb 6, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
CUSTOMER REPORTS: THE SALEM SUMP CONNECTOR BETWEEN THE NASOGASTRIC TUBE AND THE SUCTION TUBING BROKE IN HALF WHEN THE BEDSIDE NURSE ATTEMPTED TO RECONNECT THE SUCTION AFTER IT HAD BEEN CLAMPED OFF. SHE PULLED THE PIECE OUT OF THE END OF THE NASOGASTRIC TUBE AND IT BROKE LEAVING THE BLUE HALF OF THE DEVICE LODGED INSIDE THE NASAL GASTRIC TUBE (NGT). STAFF WERE ABLE TO REMOVE THE CONNECTOR FROM THE TUBE. AFTERWARD, WERE ABLE TO RESUME SUCTION. IMPACT OF INCIDENT: THE PATIENT WAS FRUSTRATED AS WE WERE UNABLE TO INITIATE THE SUCTION FOR SOME TIME UNTIL IT WAS PROBLEM SOLVED.
Patient problems: Discomfort
MAUDE report 18650819 ↗InjuryDec 15, 2023Material Separation; Material Separation
THE CUSTOMER REPORTED THAT AFTER MMO (MUCOSAL MELANOMAS OF THE ORAL CAVITY) SURGERY, THE SURGEON PLACED A NASOGASTRIC TUBE (NGT) TO SUCTION/EMPTY STOMACH FOR ANY BLOOD OR IRRIGATION THAT MIGHT HAVE WENT DOWN THE STOMACH. AFTER SUCTIONING, THE RESIDENT TOOK OUT THE NGT AND NOTICED THAT TIP OF THE TUBE WAS MISSING. THEY DID X-RAY BUT UNABLE TO LOCATE THE TIP. THEY HAD TO GO TO CT SCAN, AND THEY WERE ABLE TO LOCATE WHERE EXACTLY THE TIP WAS, FROM THERE THEY WENT BACK TO OR AND HN SURGEON RETRIEVED THE MISSING PART OF THE NGT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE PATIENT IS DOING FINE AND RECOVERED NORMALLY FROM THE PROCEDURE.
Patient problems: Foreign Body In Patient
MAUDE report 18337003 ↗MalfunctionSep 11, 2023Material Separation; Material Separation
THE CUSTOMER REPORTED THAT THE SALEM SUMP WAS REMOVED FROM THE PATIENT WITH THE DISTAL END MISSING. NONE PRESENT IN MOUTH TO SUGGEST PATIENT BITING. 52CM MISSING. ADDITIONAL INFORMATION RECEIVED ON 30AUG2023 STATED THAT THE MISSING PIECE WAS NOT LOCATED NOR REMOVED AS THE PATIENT DIED DUE TO UNRELATED ISSUES.
Patient problems: Foreign Body In Patient
MAUDE report 17720953 ↗
Other Cardinal Health, Inc. products
All Cardinal Health, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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