Dignitana, Inc. Recalls

Overview of recall records associated with Dignitana, Inc., including dates, categories and classifications where available.

1recall records

Mar 30, 2022latest record date

Mar 30, 2022earliest record date

Recall history in this database

Classification mix: Class II: 1.

Medical DeviceMar 30, 2022

Dignitana DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The recall — FDA Z-0825-2022

Instructions for Use (IFUs) updated to include use of a headband is now recommended for all patients and instructions for the application of the headband. Additionally, IFU updated to…

Class IIFDA: TerminatedDignitana, Inc.

Understanding this recall history

This page summarizes recall records in which the official source identifies Dignitana, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.

Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.