InTouch 2131 Medical Device Recalled for Distribution to Residential Users
Stryker's InTouch 2131 medical device, intended for healthcare facilities, was distributed to residential customers. Home users may not understand healthcare-specific instructions, creating a risk of improper use.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illness or injury. The device itself is not defective but was distributed to residential customers instead of healthcare facilities. Although labeling correctly identifies intended healthcare use, this distribution error creates potential for improper use by untrained users.
Plain-English summary
Stryker Medical Division of Stryker Corporation has recalled the InTouch 2131 medical device (Model 2131000000, Part #1460000000, UDI 07613327169294), intended for acute care healthcare settings. The device was distributed to residential customers and may be in use in home environments. The product labeling correctly identifies the healthcare facility use environment and is designed for healthcare professionals, but home users may not be aware of or fully understand these healthcare-specific instructions.
Two units with serial numbers U54274 and U71491 were distributed worldwide, including to the US and Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand.
The recalled product
- Product
- InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000¿¿¿¿¿¿¿
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Hazard
- improper-use
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Numbers: U54274 U71491 UDI:07613327169294
Distribution
Distributed nationwide across the United States.
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