Agency classClass IIOur severity:High FDA (Devices)·Z-2219-2021·Announced 2021-08-18

Michael Graves Stryker Highback Chair distributed to home users instead of healthcare facilities

Stryker Medical Division recalled its Michael Graves Highback Chair (Model 4853) after it was distributed to residential customers instead of healthcare facilities. Home users may not understand safety instructions written for trained medical professionals.

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 trained healthcare professionals with professional-level safety instructions. Distribution to residential home users creates a risk-of-harm situation where untrained consumers may not fully understand operating and safety requirements. No injuries have been reported to date.

Plain-English summary

Stryker Medical Division of Stryker Corporation has recalled the Michael Graves with Stryker Highback Chair (Model 4853, Serial Number G201179538, UDI 07613327506129). The device was distributed worldwide to customers in the United States, Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand.

This seating device is intended for pediatric and adult patient and guest seating in healthcare facilities. The product's labeling accurately specifies this professional healthcare environment use. However, the device was distributed to residential customers who may be using it in home environments. Home users may not be aware of or fully understand the safety instructions and operating guidelines that were developed for trained healthcare professionals.

If you have received this device, verify you are using it according to its labeling, which specifies healthcare facility use only. Contact Stryker Medical Division of Stryker Corporation with any questions about your device.

The recalled product

Product: Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating use in an indoor medical setting, Model Number 4853, Part #4853000000 ¿
Manufacturer: Stryker Medical Division of Stryker Corporation
Category: Medical Device — Patient Seating Equipment
Hazard: improper-use
use-environment-mismatch
Affected units: 1

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: G201179538 UDI: 07613327506129

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.

See all 19 products in this recall →

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