Steris Corporation Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
Brand
Steris Corporation
Lot Codes / Batch Numbers
UDI-DI (GTIN): 10889950014193 Lots 0322, 0521, 0522, and 0621
Products Sold
UDI-DI (GTIN): 10889950014193 Lots 0322, 0521, 0522, and 0621
Steris Corporation is recalling Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360 due to The scalpel holder may separate from the handle for certain lots. If the tip falls off during use, it could fall into the patient's mouth which may re. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The scalpel holder may separate from the handle for certain lots. If the tip falls off during use, it could fall into the patient's mouth which may result in a cut to the patient's mouth and also presents a choking hazard.
Recommended Action
Per FDA guidance
Starting September 2, 2022, Hu-Friedy notified all affected customers and distributors via Urgent Medical Device Recall letters. Customers were instructed to immediately destroy all on-hand inventory of the affected lots of K360 Scalpel Handles. Distributors should identify and notify any of their customers who have received further distributed product. Hu-Friedy will issue credit upon receipt of completed response forms.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IL, MA, NC, SC, TN
Page updated: Jan 10, 2026