Stryker recalls InTouch 2131 medical device sold to homes instead of hospitals. Home users may not understand healthcare-specific instructions, risking improper use.
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
Stryker is recalling a medical device (InTouch 2131) that was distributed to home users instead of healthcare facilities. This device is designed for acute care settings but home users may not understand the specialized instructions meant for healthcare professionals.
The device is designed for hospital use with specific instructions for healthcare professionals. Home users may not understand these instructions, potentially leading to improper use in a non-clinical environment.
Home users who purchased the InTouch 2131 medical device for personal use are most at risk. Healthcare facilities were not intended to use this device.
Check for model number 2131000000 and serial numbers U54274 or U71491. The device was sold to residential customers instead of healthcare facilities.
Look for model number 2131000000 and serial numbers U54274 or U71491 on the device.
No, this device is intended for acute care settings only and was distributed to residential customers instead of healthcare facilities.
The recall record does not specify a remedy, so contact Stryker directly for guidance.
The device was distributed to home users instead of healthcare facilities where it is intended to be used, and home users may not understand the specialized instructions.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-2210-2021 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2210-2021 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.