Medline Industries, Inc. DYNJS0821Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10080196986651), received between Jul 14, 2021 and Jul 14, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 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, 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.

Recalls naming this device

1. Mar 3, 2025Class IIOpen, Classified

   There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

   Z-1618-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• InjuryJul 14, 2021Break

  IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A FIRST METATARSAL OSTEOTOMY ON THE LEFT FOOT AND THE BLADE BROKE INTO 2 PIECES REQUIRING MANUAL REMOVAL OF THE BLADE FROM THE SURGICAL SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12169636 ↗