MEDLINE ART995Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 15, 2023Open, Classified

   Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

   Z-1094-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

2. May 18, 2023Open, Classified

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

   Z-2167-2023 · Root cause: Device Design · FDA record ↗

3. May 18, 2023Open, Classified

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

   Z-2193-2023 · Root cause: Device Design · FDA record ↗

4. May 15, 2023Open, Classified

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

   Z-2292-2023 · Root cause: Nonconforming Material/Component · FDA record ↗