AMT Bridle™ E4-4116Recalls & reported problems

Summary

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

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K030784, K142971); they may or may not involve this specific model.

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. Jan 19, 2017Terminated

   Expired expiration dates are listed on the pouches.

   Z-1223-2017 · Root cause: Employee error · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030784, K142971. One submission often covers many models, so check the product and lot details in each record.

• Z-1224-2017 · Jan 19, 2017 · Terminated
  AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes.