FDAClass IIAugust 18, 2021

GoBed II MedSurg Bed recall: Labeling Error

GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX

Why was GoBed II MedSurg Bed 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: R52495 R53376 R55047 R56034 M14805 M14885 M14886 M14931 M14936 M14938 M14939 M50074 M50425 M50951 M50956 M54387 R63407 R54523 R54610 R54696 R54698 R60775 R32649 R25384 R35631 R35734 R58735 M15330 R58474 UDI: 07613327169355 07613327169386

Product
GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX
Recalling firm
Stryker Medical Division of Stryker Corporation
Quantity
33 units
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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