FDA Device recall Z-0086-2027
Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal frame intended for medical purposes to provide mod…
- FDA Device
- Class II
- ongoing
- Published 2026-10-14
On 2026-10-14 the FDA classified a Class II recall of Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal frame intended for medical purposes to provide mod… by Medline Industries, citing 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 f….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0086-2027 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-14 |
| Published | 2026-10-14 |
| Last updated | 2026-10-21 05:30 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Lot Numbers: 05425090001 05425120001 05426010001 05426020001 05426030001 05426040001 05426050001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-21 05:30 UTC. Current status: ongoing.
Other recalls by Medline Industries
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FDA Device · Class II · 2026-10-21 · Medline Industries - Convenience Kits containing CONMED AirSeal Access Ports GENERAL DAVINCI DYNJG901004C LAP CHOLE DYNJ88071 ROBOTIC PACK DYNJ50474F
FDA Device · Class II · 2026-10-21 · Medline Industries - Medline surgical convenience kits labeled as: 1) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055A
FDA Device · Class II · 2026-10-21 · Medline Industries - Medline surgical convenience kits labeled as: 1) VEIN HARVESTING PACK-LF, Medline product number/SKU DYNJ0826732J
FDA Device · Class II · 2026-10-21 · Medline Industries - Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A &
FDA Device · Class II · 2026-10-21 · Medline Industries
All Medline Industries recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0086-2027%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.