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# Surgical Staplers Up-classified to Class 2
- URL: https://www.fdaweb.com/surgical-staplers-up-classified-to-class-2/
- Published: 2021-10-08T12:00:00.000Z
- Updated: 2026-09-14T17:18:25.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150329

*Federal Register* notice: FDA has issued a final order to reclassify surgical staplers for internal use from Class 1 (general controls) into Class 2 (special controls) and subject to premarket review. The agency is issuing the reclassification on its own initiative based on new information. Between 1/2011 and 3/2018, it received over 41,000 adverse event reports associated with surgical staplers and staples for internal use, including over 360 deaths. Some of the most commonly reported problems, it says, were opening of the staple line or malfunction of the staples, misfiring, difficulty in firing, failure of the stapler to fire the staple, and misapplied staples (applying to the wrong tissue or applying a staple of the wrong size). To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-10-08/pdf/2021-22041.pdf?ref=fdaweb.com).