Salem SumpRecalls & reported problems across all models

We found 31 models of Salem Sump by Cardinal Health 200, LLC in the FDA's device registry (GUDID). Together they are named in 40 adverse event reports in the FDA's MAUDE database, received between Oct 23, 2017 and Sep 21, 2026 — classified as 1 death, 3 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Break” (28 reports).

7 FDA recall records name at least one of these models by its device identifier, 7 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

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.

1. 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 4 of these models · Recall details · FDA record ↗

2. 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-0209-2026 · Root cause: Use error · names 2 of these models · Recall details · FDA record ↗

3. 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 · Recall details · FDA record ↗

4. 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 · names 10 of these models · Recall details · FDA record ↗

5. 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-0206-2026 · Root cause: Use error · names 5 of these models · Recall details · FDA record ↗

6. Jul 24, 2024Class IIOpen, Classified

   The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.

   Z-3302-2024 · Root cause: Labeling Change Control · names 4 of these models · Recall details · FDA record ↗

7. Jul 24, 2024Class IIOpen, Classified

   The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.

   Z-3301-2024 · Root cause: Labeling Change Control · names 4 of these models · Recall details · FDA record ↗

Most reported Salem Sump problems

Salem Sump models

31 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Salem Sump 8888266114

  TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
  2 recalls0 reports
• Salem Sump 8888266197

  Tubes, gastrointestinal (and accessories)
  1 recall13 reports
• Salem Sump 8888266148

  TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
  1 recall5 reports
• Salem Sump 266197

  TUBES, GASTROINTESTINAL (AND ACCESSORIES)
  1 recall5 reports
• Salem Sump 266148

  TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
  1 recall4 reports
• Salem Sump 8888266122

  TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
  1 recall2 reports
• Salem Sump 266130

  TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
  1 recall2 reports
• Salem Sump 8888264986E

  Gastrointestinal Tubes with Enteral Specific Connectors
  1 recall1 death2 reports
• Salem Sump 266122

  TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
  1 recall1 report
• Salem Sump 264929

  TUBES, GASTROINTESTINAL (AND ACCESSORIES)
  1 recall1 report
• Salem Sump 264945

  TUBES, GASTROINTESTINAL (AND ACCESSORIES)
  1 recall1 report
• Salem Sump 8888264929E

  TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
  1 recall1 report
• Salem Sump 8888264911

  Tubes, gastrointestinal (and accessories)
  1 recall0 reports
• Salem Sump 8888264929

  Tubes, gastrointestinal (and accessories)
  1 recall0 reports
• Salem Sump 8888264945

  Tubes, gastrointestinal (and accessories)
  1 recall0 reports
• Salem Sump 8888264960

  Tubes, gastrointestinal (and accessories)
  1 recall0 reports
• Salem Sump 8888264986

  Tubes, gastrointestinal (and accessories)
  1 recall0 reports
• Salem Sump 8888266130

  TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
  1 recall0 reports
• Salem Sump 8888268060

  Tubes, gastrointestinal (and accessories)
  1 recall0 reports
• Salem Sump 8888268086

  Tubes, gastrointestinal (and accessories)
  1 recall0 reports
• Salem Sump 264986

  TUBES, GASTROINTESTINAL (AND ACCESSORIES)
  1 recall0 reports
• Salem Sump 8888264911E

  TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
  1 recall0 reports
• Salem Sump 8888264945E

  TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
  1 recall0 reports
• Salem Sump 8888268060E

  Gastrointestinal Tubes with Enteral Specific Connectors
  1 recall0 reports
• Salem Sump 8888266106

  TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
  1 recall0 reports
• Salem Sump 5558264957

  Tubes, gastrointestinal (and accessories)
  1 recall0 reports
• Salem Sump 5558264965

  Tubes, gastrointestinal (and accessories)
  1 recall0 reports
• Salem Sump 5558264973

  Tubes, gastrointestinal (and accessories)
  1 recall0 reports
• Salem Sump 5558264981

  Tubes, gastrointestinal (and accessories)
  1 recall0 reports
• Salem Sump 7771810E

  Gastrointestinal Tubes with Enteral Specific Connectors
  2 reports
• Salem Sump 266197

  Tubes, 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.

• MalfunctionSep 21, 2026Break; Separation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846245 ↗
• MalfunctionMay 14, 2026Break

  THE CUSTOMER REPORTED THAT DURING AN ATTEMPT TO REMOVE THE PLUG FROM THE NG TUBE IN ORDER TO RECONNECT IT TO SUCTION, THE PLUG BROKE AND BECAME STUCK INSIDE THE TUBE. AS A RESULT, THE NG TUBE COULD NOT BE RECONNECTED TO SUCTION. ATTEMPTS WERE MADE TO REMOVE THE BROKEN PLUG; HOWEVER, THE PIECES CAME OUT IN FRAGMENTS AND PART OF THE PLUG REMAINED LODGED INSIDE THE TUBE. THE TUBE WAS THEREFORE UNABLE TO BE USED FOR SUCTION. FURTHER ASSISTANCE WAS REQUIRED TO ADDRESS THE ISSUE. THE CUSTOMER STATED THAT THE PLUG THAT COMES WITH THE TUBING APPEARED TO BE THE ISSUE. THEY ALSO HAVE SEPARATE PLUGS AVAILABLE, AND WHEN THEY USED ONE OF THOSE, IT DETACHED EASILY WITHOUT ANY PROBLEMS. ADDITIONAL INFORMATION RECEIVED ON 13MAY2026 CONFIRMED THAT THE ISSUE WAS WITH THE ARV VALVE. THEY CANNOT CONFIRM THE REPORTED LOT NUMBER AS THE STAFF PROVIDED THE NUMBERS THAT THEY HAD AT THE TIME. THEY DIDN¿T HAVE TO INSERT ANOTHER TUBE, BUT THE PATIENT WAS QUITE ANXIOUS WHEN THEY INITIALLY COULDN¿T REMOVE IT. STAFF ASSISTED BY APPLYING COUNTER PRESSURE WHILE TWO PEOPLE ATTEMPTED TO REMOVE IT, BUT IT WOULDN¿T BUDGE. THEY THEN CALLED ANOTHER PERSON IN TO STABILIZE THE TUBE AT THE PATIENT¿S NOSE TO ENSURE THEY DID

  Patient problems: Anxiety

  MAUDE report 25173032 ↗
• MalfunctionApr 7, 2026Break

  THE CUSTOMER REPORTED THE SALEM SUMP ANTI-REFLUX VALVE BROKE IN HALF WITH THE BLUE PORTION TRAPPED IN THE PATIENT'S NASOGASTRIC TUBE AND HAD TO BE REMOVED WITH A KELLY CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24806284 ↗
• MalfunctionMar 9, 2026Break; Separation Failure

  THE CUSTOMER REPORTED THE CONCERN IS THAT THE ANTI-REFLUX VALVE EASILY BREAKS OR BECOMES LODGED IN THE NG TUBE. PER THE CUSTOMER, IF IT GETS STUCK IN THE TUBE, THE CONTENTS FROM THE BROKEN VALVE COULD POTENTIALLY ENTER THE PATIENT'S STOMACH. IT HAS OCCURRED ON THEIR UNIT SEVERAL TIMES WHERE IT BREAKS. PER ADDITIONAL INFORMATION PROVIDED ON MARCH 06, 2026 THE ISSUE IS OCCURRING DURING PATIENT USE. THERE HAVE BEEN OCCASIONS WHEN NURSING STAFF ATTEMPTED TO REMOVE THE ARV, AND IT BROKE OFF INSIDE THE TUBE. IN SOME CASES, THE ENTIRE TUBE HAD TO BE REPLACED. OTHER TIMES THE ARV WAS REMOVED, BUT IT REQUIRED SIGNIFICANT FORCE. THEY AREN'T ABLE TO PROVIDE SPECIFIC DETAILS OF EACH INCIDENT THAT HAS OCCURRED AS THEY WERE NOT DOCUMENTED, IT WAS ONLY MENTIONED TO THEM DURING THEIR STAFF HUDDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545142 ↗
• MalfunctionMar 3, 2026Material Separation

  THE CUSTOMER REPORTED THAT THEY HAD A PATIENT WHO HAD HEART SURGERY. AFTER CHEST TUBE INSERTION, THE SALEM SUMP WAS INSERTED INTO EACH CHEST TUBE TO SUCTION THE DRAINAGE. AFTER STERNAL WIRING, THE SCRUB TECH WAS HAVING A PROBLEM PULLING THE SALEM SUMP FROM ONE OF THE CHEST TUBES. THE SURGEON TRIED TO PULL IT. THE TIP OF THE SALEM SUMP WAS NOTED MISSING WHEN IT CAME OUT. X-RAY WAS DONE BUT RADIOLOGIST WAS UNABLE TO VISUALIZE THE TIP. XRAY RESULT WAS RELAYED TO SURGEON. INCIDENT REPORT WAS MADE. PHOTO ATTACHED. PER ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON 27FEB2026, THE SALEM SUMP WAS USED TO SUCTION THE DRAINAGE OF THE CHEST TUBE RIGHT AFTER INSERTION OF THE CHEST TUBES WHILE THE CHEST WAS STILL OPEN AND DURING STERNAL CLOSURE. THE MEASUREMENT ON THE TUBE SERVES AS GUIDE ON HOW FAR THE SUMP IS INSERTED INTO THE CHEST TUBE. IDEALLY THE SUMP NEEDS TO BE MOBILIZED DURING STERNAL WIRING. THEY STATE THIS IS ALSO A PRACTICE IN SOME HOSPITALS. ONCE THE CHEST IS CLOSED, THE SUMP IS REMOVED, THEN THE CHEST TUBE IS CONNECTED TO THE PLEURAVAC. UNFORTUNATELY, AFTER STERNAL WIRING, THE SCRUB PERSON COULD NOT REMOVE IT, SO THE SURGEON PULLED IT FORCEFULLY. THE TIP OF THE TUBE HAS NOT BE

  Patient problems: Insufficient Information

  MAUDE report 24501147 ↗
• InjuryFeb 9, 2026Material Separation

  THE CUSTOMER REPORTED APPROXIMATELY 1.6CM OF THE TIP OF THE TUBE BROKE OFF INTO A PATIENT'S SINUSES ON REMOVAL, WHICH LED TO ADDITIONAL IMAGING, ADDITIONAL PROCEDURES, PROLONGED VENTILATOR SUPPORT, AND HIGHER LEVEL OF CARE. PER ADDITIONAL INFORMATION PROVIDED BY THE REPORTER ON 06FEB2026, THE FOLLOWING IMAGING WAS PERFORMED: (B)(6) 2026 1848: PORTABLE CXR, (B)(6) 2026 2143: CT HEAD WITHOUT CONTRAST, (B)(6) 2026 2145: CT NECK WITHOUT CONTRAST, (B)(6) 2026 0927: XR SKULL 1-3 VIEWS PORTABLE, (B)(6) 2026 1434: CT HEAD WITHOUT CONTRAST, (B)(6) 2026 1435: CT NECK WITHOUT CONTRAST, AND (B)(6) 2026 1435: CT CHEST WITHOUT CONTRAST. THE FOLLOWING PROCEDURES WERE PERFORMED: EGD PERFORMED DURING ORIGINAL SURGERY BY SURGICAL TEAM AND ENT PERFORMED NASOPHARYNGEAL AND OROPHARYNGEAL SCOPES DURING ORIGINAL SURGERY. REGARDING THE PROLONGED VENTILATOR SUPPORT, THE PATIENT REMAINED INTUBATED UNTIL (B)(6) 2026 AT 1231 DUE TO POSSIBLE CHOKING HAZARD (41H 6M OF PROLONGED VENT TIME) (B)(6) 2026 1925-(B)(6) 2026 1231). THE PATIENT REQUIRED ICU STAY DUE TO THE VENTILATOR REQUIREMENT. THE NG TIP WAS FOUND ON (B)(6) AT 0800 TO BE IN THE PATIENT¿S STOMACH ON REPEAT IMAGING. THE PATIENT WAS DISCHARGED TO PRISON

  Patient problems: Foreign Body In Patient

  MAUDE report 24296298 ↗
• MalfunctionFeb 5, 2026Break

  THE CUSTOMER REPORTED THIS PRODUCT HAS BEEN BREAKING OFF AT THE WHITE HALF WITH THE PERFORATED HOLES. THIS LEAVES THE BLUE HALF LODGED IN THE NG. THIS HALF IS ALMOST IMPOSSIBLE TO REMOVE UNLESS MANIPULATED WITH THE USE OF LARGE PLIERS AND SCISSORS, WHICH THEY WERE ABLE TO DO FOR THIS PATIENT. THIS DID CAUSE STRESS AND UNNECESSARY DISCOMFORT TO THE PATIENT. THIS IS NOT THE FIRST TIME THIS PRODUCT HAS BROKE WHILE IN USE WITH A PATIENT AND IT ALWAYS BREAKS AT THAT SAME SPOT.

  Patient problems: Anxiety; Discomfort

  MAUDE report 24274966 ↗
• MalfunctionFeb 5, 2026Break

  THE CUSTOMER REPORTED AN ONGOING ISSUE WITH THE SPIGOT SNAPPING ON THE WHITE PART WHEN TRYING TO REMOVE FROM NG TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24274952 ↗
• MalfunctionFeb 5, 2026Break

  THE CUSTOMER REPORTED THAT ONE OF THE ANTI REFLUX VALVES FROM THE LAST DELIVERY WAS BROKEN IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272234 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED AT 2100H THE WRITER WENT TO CHECK THE PATIENT WITH THE NIGHT DOSE OF MEDICATION AND THE PATIENT WAS FOUND TO HAVE A LOT OF SPUTUM AROUND HER MOUTH AND SHE WAS SEMI RESPONSIVE. THE WRITER DID ORAL SUCTION AND CHECKED THE PATIENTS' VITAL SIGNS. THE RAPID RESPONSE TEAM WAS INITIATED. PATIENT'S GCS DECREASED TO 12. PATIENT'S BLOOD PRESSURE WAS 79/30MMHG, HEART RATE WAS 166, TEMPERATURE WAS 39.7. TYMPANIC. DR. (B)(6) WAS INFORMED ABOUT THE PATIENT'S HEALTH STATUS. AT 2110H THE PATIENT WAS HANDED OVER TO THE RAPID RESPONSE TEAM. DR. (B)(6) ARRIVED AT 2140H. ECG, CHEST X-RAY, BLOOD TEST, IV LINES, VASOPRESSORS, MEDICATION, AND A FOLEY CATHETER WAS INSERTED BY RAPID RESPONSE TEAM. AFTER INTERVENTION AND TREATMENT, MD DECIDED TO SEND THE PATIENT TO THE ICU. BASED ON ALL AVAILABLE INFORMATION, THERE IS NO ALLEGATION OF A PRODUCT MALFUNCTION AT THIS TIME. MULTIPLE GOOD FAITH EFFORTS HAVE BEEN MADE TO REQUEST ADDITIONAL INFORMATION FROM THE REPORTER. HOWEVER, TO DATE A RESPONSE HAS NOT YET BEEN RECEIVED.

  Patient problems: Fever; Low Blood Pressure/ Hypotension; Pneumonia; Tachycardia

  MAUDE report 23995577 ↗
• MalfunctionSep 3, 2025Separation Failure; Separation Failure

  THE CUSTOMER REPORTED THEY RECENTLY SWITCHED TO THESE ARVS AND ARE HAVING ISSUES WITH THE DEVICE GETTING STUCK TO THE NG TUBE. ARV CONNECTED BLUE SIDE TO BLUE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952045 ↗
• MalfunctionAug 15, 2025Break; Break

  THE CUSTOMER REPORTED THAT THE PRODUCT BROKE DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22817755 ↗
• DeathAug 4, 2025Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED AN INSERTION ON (B)(6) 2025 OF A NASOGASTRIC TUBE ON A PATIENT WHO WAS POORLY RELIEVED. THE PATIENT WAS TRANSFERRED TO IMAGING FOR A CT SCAN TO IDENTIFY THE CAUSE OF THE OCCLUSION. PERSISTENCE OF VOMITING ON CT SCAN WITH MASSIVE INHALATION RESPONSIBLE FOR CARDIOPULMONARY ARREST NOT RECOVERED IN RADIOLOGY. IN ALL LIKELIHOOD, THE SUCTION OF THE NASOGASTRIC TUBE WAS UNSATISFACTORY DUE TO THE LACK OF OPENING OF THE AIR INTAKE SYSTEM. INDEED, IN THE ABSENCE OF AN ANTI-BACKFLOW VALVE, THE ENFIT CONNECTOR HAS BEEN CONNECTED TO THE PROBE, WITH THE CAP CLOSED. CURRENT PATIENT CONDITION: ABSENCE OF SUCTION FOR SEVERAL HOURS. CARDIOPULMONARY ARREST FOLLOWED BY THE PATIENT'S DEATH. ON (B)(6) 2025, (B)(6) CARDINAL HEALTH SALES REP, REPORTED SHE HAD A DISCUSSION WITH CUSTOMER, (B)(6), HEAD NURSE AND CONFIRMED THERE WERE NO PROBLEMS WITH THE DEVICE. INSTEAD, THERE WAS A LACK OF KNOWLEDGE ON THE PART OF SOME CAREGIVERS. ADDITIONAL PRODUCT TRAINING WILL BE PROVIDED BY CARDINAL HEALTH SALES TEAM. THE SALES REP ALSO STATED THAT THE CAPPED ENFIT WAS IN THE BLUE PORT. THE FACILITY DID NOT HAVE ACTIVE SUCTION HOOKED UP TO THE CLEAR PART OF THE TUBE. THEY HAD GOTTEN RETURN OF STOMAC

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Aspiration/Inhalation; Vomiting

  MAUDE report 22709105 ↗
• MalfunctionJul 7, 2025Break; Break

  THE CUSTOMER REPORTED THAT THE ANTI REFLUX CAP HAS BROKEN IN HALF. PER CUSTOMER, THE NURSE WAS WITH THE PATIENT IN BED DURING THE INCIDENT, THE PATIENT DID NOT KNOW WHY THE CAP HAD BROKEN IN HALF. THE ISSUE WAS DETECTED DURING THE COMMISSIONING OF THE PRODUCT; THIS HAS HAD NO CONSEQUENCES FOR THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22430825 ↗
• MalfunctionJun 19, 2025Break; Break

  THE CUSTOMER REPORTED THAT THE ANTI REFLUX CAP HAS ALREADY BROKEN IN HALF 2 TIMES. PER CUSTOMER, FIRST TIME, THE NURSE COULDN'T GET THE CAP OFF AND THEN IT BROKE IN HALF. SECOND TIME WAS IN BED WITH THE PATIENT, THE PATIENT DID NOT KNOW WHY IT HAD BROKEN IN HALF. THE ISSUE WAS DETECTED DURING THE COMMISSIONING OF THE PRODUCT; THIS HAS HAD NO CONSEQUENCES FOR THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292865 ↗

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