Level 1 SWU-2001Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10610586043321), received between Jul 31, 2019 and Mar 3, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Heating” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Unintended Electrical Shock

  IT WAS STATED THAT WHEN TOUCHED, THE BLANKET CAUSES AN ELECTRIC SHOCK. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: Electric Shock

  MAUDE report 24501224 ↗
• MalfunctionFeb 11, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE AIR WAS ESCAPING FROM THE BLANKET. THIS OCCURRED WHILE IN USE WITH THE PATIENT DURING INFUSION, NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355086 ↗
• MalfunctionNov 20, 2024Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT THE WARMING BLANKET OFTEN WHEN TOUCHING IT GIVES AN ELECTRIC SHOCK. THE PERSON WHO RECEIVED AN ELECTRIC SHOCK WAS THE NURSE. THE INCIDENT OCCURRED DURING REMOVING THE COVER AND THERE WERE NO REPORTED INJURIES, BUT THE DISCHARGE IS SO STRONG THAT IT WAS FELT FOR SOME TIME. CUSTOMER ALSO STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Electric Shock

  MAUDE report 20739323 ↗
• MalfunctionNov 19, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "THE PART WHICH IS NOT SUPPOSED TO EXPAND EXPANDS". THIS OCCURRED DURING PRIMING, NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20724970 ↗
• MalfunctionNov 4, 2024Insufficient Heating; Insufficient Heating

  IT WAS REPORTED THAT THE DEVICE COULDN'T BE HEATED UP TO THE TOP, AND ONLY HEATED HALFWAY. THIS OCCURRED DURING INFUSION AT THE FACILITY. THERE WAS PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598248 ↗
• MalfunctionOct 8, 2024Insufficient Heating; Insufficient Heating

  IT WAS REPORTED THAT THE ADHESIVE PEELED OFF, AND WHEN AIR IS BLOWN ON IT, ONLY ONE PART EXPANDS, SO THE HEAT DOES NOT REACH THE TOP. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20400313 ↗
• InjuryJul 31, 2019Temperature Problem; Temperature Problem

  INFORMATION WAS RECEIVED INDICATING THAT FOLLOWING USE OF A SMITHS MEDICAL LEVEL 1® SMITHS MEDICAL LEVEL 1® SNUGGLE WARM® BLANKET PHLYCTEN WAS NOTED TO THE PATIENT'S RIGHT FOREARM. SUBSEQUENTLY, VASELINE GAUZE AND BIAFINE CREAM WAS APPLIED TO THE BURN. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 8848652 ↗
• InjuryJul 31, 2019Temperature Problem; Temperature Problem

  INFORMATION WAS RECEIVED INDICATING THAT UPON REMOVAL OF A SMITHS MEDICAL LEVEL 1® SNUGGLE WARM® BLANKET ERYTHEMA WAS NOTED TO THE PATIENT'S ARM, FOREARM, CHEST AND ABDOMEN. THE RIGHT FOREARM WAS REPORTED TO SHOW THE BEGINNING OF PHLYCTEN. THE CLINICIAN STATED THAT THE PATIENT WAS WELL POSITIONED ON THE BLANKET WITHOUT ANY EXTERNAL CONSTRAINT. THE WARMER WAS REPORTED TO SET TO 44 DEGREES CELSIUS BUT THE DISPLAY HAD READ 37 DEGREES CELSIUS. SUBSEQUENTLY, BIAFINE WAS PRESCRIBED FOR DRESSINGS. THERE WERE NO FURTHER REPORTED ADVERSE EFFECTS.

  Patient problems: Erythema; Partial thickness (Second Degree) Burn; Superficial (First Degree) Burn

  MAUDE report 8848545 ↗