Medline Industries, Inc. SYNJ910004CRecalls & reported problems

Summary

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

2 FDA recall records name this device's identifier, 2 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. Oct 4, 2024Class IIOpen, Classified

   Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap.

   Z-0350-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Sep 4, 2024Class IIOpen, Classified

   It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

   Z-0179-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗