Medline Industries, Inc. DYNJ51038RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10195327298258), received between Aug 18, 2026 and Aug 31, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 reports).

4 FDA recall records name this device's identifier, 4 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. May 4, 2026Class IIOpen, Classified

   During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

   Z-2487-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Sep 30, 2025Class IIOpen, Classified

   Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

   Z-0513-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Feb 21, 2025Class IOpen, Classified

   Medline medical procedure kits, containing Medtronic Aortic Root Cannula

   Z-1456-2025 · Root cause: Other · Recall details · FDA record ↗

4. Oct 9, 2024Class IIOpen, Classified

   Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

   Z-0625-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionAug 31, 2026Physical Resistance/Sticking

  It was reported that bullet tip punch on aortic punch locks up inside the device, comes in medline pack.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50531279 ↗
• MalfunctionAug 18, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50303561 ↗