Surgistool (Stryker) – Residential Use Risk (2021)
This recall involves a labeling issue.
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
Surgistool-intended to support a healthcare professional during surgical procedures Model 830, Part Number 0830000000
Brand
Stryker Medical Division of Stryker Corporation
Lot Codes / Batch Numbers
Serial Numbers: 1202033898 1206032470 1406034563 1607037109 UDI (DI#): 07613327282566
Products Sold
Serial Numbers: 1202033898 1206032470 1406034563 1607037109 UDI (DI#): 07613327282566
Stryker Medical Division of Stryker Corporation is recalling Surgistool-intended to support a healthcare professional during surgical procedures Model 830, Part due to Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The prod. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals
Recommended Action
Per FDA guidance
Stryker notified users/consumers via written notification Urgent Medical Device Removal letter notified via FedEx on Friday, June 18, 2021. In addition, customers may be contacted by phone or email. International distribution divisions were notified by validated electronic system (Trackwise) on May 13, 2021. Letter states reason for recall, health risk and action to take: Customers are instructed to: 1. Identify the medical device shipped to your location (see the attached business reply form for product details and serial number). 2. If you are using the product in a home, Stryker recommends that you discontinue use of the product. 3. Complete and sign the enclosed business reply form. a. Return this signed letter by fax (269) 488-8691or email productfieldaction@stryker.com to Stryker's Regulatory Department. 1. Identify the medical device shipped to your location (see the attached business reply form for product details and serial number). 2. If you are using the product in a home, Stryker recommends that you discontinue use of the product. 3. Complete and sign the enclosed business reply form. a. Return this signed letter by fax 269 488 8691 or email productfieldaction@stryker.com to Strykers Regulatory Department. 4. Upon receipt of the signed business reply form, Stryker will contact you to arrange the removal of your product(s) if applicable. If you have any questions or concerns, contact us at +1 269 389 8306 or productfieldaction@stryker.com. We apologize for any disruption this may cause.
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 noticePage updated: Jan 10, 2026