Medline Industries, Inc. DYNJ70141MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889942722808), received between Jan 10, 2023 and Jan 10, 2023 — classified as 1 injury.

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. Jan 7, 2026Class IIOpen, Classified

   Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

   Z-2094-2026 · Root cause: Process control · Recall details · FDA record ↗

2. Jan 7, 2026Class IIOpen, Classified

   Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

   Z-1391-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. May 18, 2023Class IIOpen, Classified

   Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

   Z-2200-2023 · Root cause: Device Design · Recall details · FDA record ↗

4. May 15, 2023Class IIOpen, Classified

   Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

   Z-2323-2023 · Root cause: Nonconforming Material/Component · 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.

• InjuryJan 10, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE FACILITY ON (B)(6) 2022 WHEN 'ATTEMPTING TO PLACE A PICC LINE THE NURSE MET RESISTANCE WHILE THREADING THE GUIDEWIRE'.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16130514 ↗