FDAClass IIAugust 18, 2021

Michael Graves with Stryker Highback Chair-intended for recall: Labeling Error

Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating use in an indoor medical setting, Model…

Why was Michael Graves with Stryker Highback Chair-intended for recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial Numbers: G201179538 UDI: 07613327506129

Product
Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating use in an indoor medical setting, Model…
Recalling firm
Stryker Medical Division of Stryker Corporation
Quantity
1 unit
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
Recall date
August 18, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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