Medline Industries, Inc. DYNJ905153KRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10195327187866), received between Dec 20, 2022 and Dec 20, 2022 — classified as 1 malfunction.

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. Feb 27, 2026Class IIOpen, Classified

   Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

   Z-2583-2026 · Root cause: No Marketing Application · 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.

• MalfunctionDec 20, 2022Break

  METAL PART OF THE INJECTION NEEDLE THAT COMES WITH THE BARIATRIC PACK BROKE OFF WHILE INJECTING LOCAL ANESTHESIA. ULTRASOUND AND C-ARM IMAGING WAS USED TO LOCALIZE THE NEEDLE. THE NEEDLE WAS BETWEEN THE PATIENT'S SKIN AND PERITONEUM. DR WAS ABLE TO GET THE NEEDLE OUT BY PUSHING THE NEEDLE INTO THE PERITONEUM WITH DIRECT VISUALIZATION FROM THE LAPAROSCOPE AND GRABBED IT WITH A MARYLAND GRASPER. BARIATRIC PACK REORDER NO: (B)(4), LOT: 22IMF393, GTIN (B)(4), EXP: 10/31/2023.

  Patient problems: Laceration(s)

  MAUDE report 16026542 ↗