Stryker Medical Division of Stryker Corporation InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000
Brand
Stryker Medical Division of Stryker Corporation
Lot Codes / Batch Numbers
Serial Numbers: U54274 U71491 UDI:07613327169294
Products Sold
Serial Numbers: U54274 U71491 UDI:07613327169294
Stryker Medical Division of Stryker Corporation is recalling InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000 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