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Medline Industries, Inc. SYNJ10248BRecalls & reported problems

Medline Industries, Inc. · VAGINAL DELIVERY PACK · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
2

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. Mar 3, 2025Class IIOpen, Classified

    There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

    Z-1611-2025 · Root cause: Under Investigation by firm · 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-0174-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Other Labor and Delivery Kit devices

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Sources and updates

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