Class 2 Device Recall ollator, Bariatric, Basic Steel, Blue

• Date Initiated by Firm: August 14, 2026
• Date Posted: October 05, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0087-2027
• Recall Event ID: 99807
• Product Classification: Walker, mechanical - Product Code ITJ
• Product: Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support while walking, Product Number MDS86800XWBS
• Code Information: Lot Numbers: 05425080001 05426040001
• FEI Number: 1417592
• Recalling Firm/ Manufacturer: Medline Industries, LP; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Haley Barclay; 866-359-1704
• Manufacturer Reason for Recall: The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the front wheels may become loose or detach from the rollator. If the front wheels become loose or detach during use, there is risk of severe adverse events. The immediate consequences could include falls resulting in head trauma, bone fractures, or other critical injuries.
• FDA Determined Cause: Process control
• Action: An URGENT MEDICAL DEVICE RECALL notification letter was sent to customers beginning 8/14/26. REQUIRED ACTION: 1. Inspect Your Rollator Immediately " Please refer to Image 1: How to locate and identify the product Lot Number to locate the front and rear side of the rollator. " On the rear side of the rollator, you will find the Lot Label is located on the left side frame tubing, below the seat frame tubing. 2. If your rollator matches both the affected SKU and an affected Lot Number, immediately discontinue use of the device. Take a clear photograph of the Lot Label and contact Medline Industries, LP directly, as soon as possible. A photograph of the Lot Number must be submitted to Medline for verification. You may contact Medline Industries, LP using one of the following methods: " Email: QualityAssurance@medline.com " Phone: 1-800-950-0128 option 5 Once Medline receives and confirms your Lot Number, further instructions regarding discontinued use of the affected rollator will be provided. 3. If your rollator does not have one of the affected Lot Numbers, it may continue to be used in accordance with the Instructions for Use. Please complete and return the attached response form only if you do not have the affected rollator Lot Number. 4. If you have resold, distributed, or transferred this product to another company or individual, FDA regulations require that you notify those recipients of this recall communication. Please contact Medline Industries, LP for further instructions regarding the identification, notification, and handling of affected products distributed to your customers. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
• Quantity in Commerce: 835 units
• Distribution: Worldwide distribution - US Nationwide and the country of Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.