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ACS SFEA12ARecalls & reported problems

American Contract Systems, Inc. · EAR PACK · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names 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
1

Summary

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

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 16, 2026.

Recalls naming this device

  1. Feb 6, 2025Open, Classified

    ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

    Z-1351-2025 · Root cause: Process control · Recall details · FDA record ↗

Other Ear, nose, and throat surgical tray devices

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page