Symmetry Plus Treatment Recliner distributed to home users instead of healthcare facilities
A medical treatment recliner designed for healthcare facilities was distributed to home consumers. Home users may not understand the specialized instructions intended for healthcare professionals, creating a potential safety risk.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II medical device was designed for use by healthcare professionals but was distributed to home consumers. Without professional oversight and understanding of specialized instructions, untrained home users face a risk of improper use. Although no injuries have been reported, the misdistribution to an unintended user population creates a risk-of-harm situation.
Plain-English summary
Stryker Medical has recalled the Symmetry Plus Treatment Recliner (Model 3500), a device designed for use in healthcare facilities as a patient or guest seating surface.
Three units were distributed to residential customers instead of the intended healthcare setting and may now be in use in home environments.
The device labeling correctly identifies its intended use in healthcare facilities, but home users may not be aware of or fully understand the specialized instructions designed for trained healthcare professionals. Use of this device by untrained home users creates a potential safety risk.
Consumers who have received this device should understand that it is not designed for use outside a healthcare setting. Review the product labeling and ensure you understand the specialized instructions are intended for healthcare professionals.
The recalled product
- Product
- Symmetry Plus Treatment Recliner - general hospital use as a convenient seating surface for patients or guests to sit, Model Number 3500, Part # 3500000710
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Hazard
- Affected units
- 3
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: G201170298 G201181816 G201318385 UDI: 07613327282436
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by Stryker Medical Division of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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