The Recall Desk
HighFDA (Devices)·Z-2218-2021·Announced 2021-08-18

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.

What this means for you

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
Category
Medical Device — Hospital Equipment
Hazard
  • improper-use
  • user-error

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.

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