Sodium Chloride Inhalation Solution, USP, 0.9% 15 mL UDVRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00376204300506), received between Nov 20, 2023 and May 28, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2025Use of Device Problem; Use of Device Problem

  THIS SPONTANEOUS REPORT FROM THE UNITED STATES WAS REPORTED BY A FEMALE PATIENT (UNSPECIFIED AGE) WHO USED SODIUM CHLORIDE INHALATION SOLUTION 0.9% FOR HER SCLERAL LENS AND ACANTHAMOEBA. IN AN UNSPECIFIED DATE IN 2022-2023, THE PATIENT-INITIATED TREATMENT WITH SODIUM CHLORIDE INHALATION SOLUTION, USP, 0.9% (UNSPECIFIED DOSING DETAILS) VIA THE OPHTHALMIC ROUTE FOR SCLERAL LENS. ON AN UNSPECIFIED DATE IN 2024, THE PATIENT HAD ACANTHAMOEBA PARASITE IN THE RIGHT EYE FOLLOWING SHE HAD EVISCERATION OF RIGHT EYE ON (B)(6) 2024. SHE STATED THAT SHE HAS STOPPED USING HER LENSES SINCE (B)(6) 2024. ACTION TAKEN WITH SODIUM CHLORIDE INHALATION SOLUTION WAS UNKNOWN. THE OUTCOME OF THE EVENT ACANTHAMOEBA WAS UNKNOWN. THE OUTCOME OF THE EVENT USING SODIUM CHLORIDE INHALATION SOLUTION 0.9% FOR HER SCLERAL LENS WHICH SHE GOT THROUGH DOCTOR'S PRESCRIPTION WAS NOT APPLICABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 30-APR-2025: EVENT OF MISUSE UPDATED TO OFF LABEL, ADDITIONAL EVENT (ACANTHAMOEBA PARASITE IN THE RIGHT EYE), THERAPY START DATE, MEDICAL HISTORY, CONCOMITANT MEDICATIONS ADDED, AND EVENT DESCRIPTION UPDATED.

  Patient problems: Infective Keratitis

  MAUDE report 22095307 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT FROM THE UNITED STATES WAS REPORTED BY A CONSUMER AND CONCERNS A 75-YEAR-OLD FEMALE, WHO EXPERIENCED SWELLING OF LIPS AND TONGUE, FLUSHED RED FACE/FACE RED, ALLERGIC REACTION TO NEBULIZER SOLUTION AND SOB (SHORTNESS OF BREATH) COINCIDENT WITH SODIUM CHLORIDE INHALATION SOLUTION (B)(4). ON (B)(6) 2023, THE PATIENT WAS HOSPITALIZED FOR VOCAL CORD REPAIR SURGERY DUE TO VOCAL CORD PARALYSIS AND THEY ACCIDENTALLY LACERATED HER OESOPHAGUS. DURING HOSPITALIZATION, THE PATIENT RECEIVED INTRAVENOUS (IV) MEDICATION AT THE HOSPITAL THAT INCLUDED IV ANCEF CONTINUOUSLY FOR 24-48 HOURS, IV IBUPROFEN AND IV TYLENOL POST-SURGERY. ON THE SAME DAY AFTER THE SURGERY, THE PATIENT-INITIATED SODIUM CHLORIDE INHALATION SOLUTION (B)(4) VIA NEBULIZER AND FACE MASK OVER THE NEXT FOUR DAYS. THE PATIENT ALSO RECEIVED LIQUID IBUPROFEN BEFORE GOING HOME. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED FROM HOSPITAL. THE PATIENT HAD ANOTHER BREATHING TREATMENT OF (B)(4) WITH SODIUM CHLORIDE INHALATION SOLUTION. AFTER THE TREATMENT, SHE HAD AN ALLERGIC REACTION. THE PATIENT'S SYMPTOMS INCLUDED FACE BEING FLUSHED RED, SWELLING OF LIPS AND TONGUE. THE PATIENT HAD SOB. SHE TOOK BENADRYL (DIPHENHYD

  Patient problems: Decreased Respiratory Rate; Hot Flashes/Flushes; Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 18168065 ↗