GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX
Check against the official notice below — it lists the full affected range.
Stryker Corporation's GoBill II MedSurg Bed (Model FL28) has been recalled because 33 units intended for use in healthcare facilities were distributed to residential customers instead. Although the product's labeling correctly identifies that it is designed for use by healthcare professionals in medical facilities, home users may not be aware of or fully understand these instructions, creating a potential hazard.
The affected beds were distributed worldwide, including throughout the United States and to Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand. The recall involves specific units identified by serial numbers, with a complete list of affected serial numbers and UDI codes available in the recall record. The source does not specify what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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
Reason for recall: 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 Distribution: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand. Quantity: 33 units Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.