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# FDA Reiterates Concern with Some Cardinal Surgical Gowns
- URL: https://www.fdaweb.com/fda-reiterates-concern-with-some-cardinal-surgical-gowns/
- Published: 2020-02-05T12:00:00.000Z
- Updated: 2026-09-14T16:01:58.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146014

FDA has again posted an online notice that Cardinal Health has alerted its customers to potential quality issues affecting some of its Level 3 surgical gowns and PreSource Procedure Packs containing those gowns. The [notice](https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gowns?ref=fdaweb.com) says the company has sent urgent medical device recall letters for the devices to its customers.

“FDA is working closely with Cardinal Health during this rapidly evolving situation to understand and address the quality issues with these products,” the notice says. It also references an FDA 1/16 [statement](https://www.fdaweb.com/dont-use-certain-level-3-surgical-gowns-cardinal-health/) from CDRH director **Jeffrey Shuren** on the recall and the FDA actions.