Recall Z-0086-2027 ยท ITJ Walker, Mechanical
Medline Industries, LP
Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support while walking, Product Number MDS86800XWS
| Date | Oct 5, 2026 (initiated Aug 14, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 Industr |
| Quantity | 1824 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.