Medline Industries, Inc. DYNJRA9034Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10193489467574), received between Feb 19, 2025 and Feb 19, 2025 — 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. Apr 10, 2026Class IOpen, Classified

   Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.

   Z-2237-2026 · Root cause: Component design/selection · 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.

• InjuryFeb 19, 2025Break; Break

  ACCORDING TO THE FACILITY ON 1/27, "THE INCIDENT THAT OCCURRED ON (B)(6) 2025 AT (B)(6), INVOLVING A PATIENT DURING AN ATTEMPTED SPINAL EPIDURAL PROCEDURE PERFORMED BY THE ANESTHESIA PROVIDER. DURING THE PROCEDURE, THE PROVIDER INTRODUCED A 25G SPINAL NEEDLE/INTRODUCER INTO THE PATIENT'S BACK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21411022 ↗