Levo Standard Package 7887-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842430114021), received between Jun 19, 2026 and Jun 19, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Unintended Movement” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2026Use of Device Problem; Unintended Movement

  DURING THE SURGICAL PROCEDURE, THE DEVICE WAS APPLIED TO THE PATIENT AND THE OPERATOR CONFIRMED A PINNING PRESSURE OF 80 LBS. WHEN REPOSITIONING OF THE PATIENT'S HEAD WAS ATTEMPTED, THE PATIENT WAS OBSERVED TO HAVE SLID INTO A DIFFERENT POSITION RELATIVE TO THE DEVICE. THE PROCEDURE WAS COMPLETED; HOWEVER, UPON CONCLUSION A 2-3 INCH LACERATION WAS NOTED ON THE POSTERIOR ASPECT OF THE PATIENT'S HEAD.

  Patient problems: Laceration(s)

  MAUDE report 25565746 ↗