Class II recall Z-0086-2027: Medline Industries, LP
Class II recall Z-0086-2027: Medline Industries, LP (Illinois): Medline Industries, LP. Dated 21 days ago, it is in the active follow-up window. Score 62/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Free preview: all 14 published fields of this record are shown below. Locked: 56 related IL FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0086-2027 |
| Recalling firm | Medline Industries, LP |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| 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. |
| Quantity | 1824 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| Recall initiated | 2026-08-14 |
| Reported | 2026-10-14 |
| Firm location | Northfield, IL, United States |
| Peer records CSV (57 IL records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-14
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Class II recall Z-0086-2027: Medline Industries, LP and 57 Illinois peers
- Illinois FDAPulse records like this one: 57
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Illinois peer: $11,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
62 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 21 days ago.
What is the FDAPulse record for Class II recall Z-0086-2027: Medline Industries, LP in Illinois?
Class II device recall Z-0086-2027 by Medline Industries, LP: The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel
How does Class II recall Z-0086-2027: Medline Industries, LP compare to other Illinois FDAPulse records?
It is 21 days old, still within a typical 45-day follow-up window.
Class II recall Z-0086-2027 vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-0086-2027 | IL | 2026-10-14 |
| Class II recall Z-0281-2027 | IL | 2026-10-28 |
| Class II recall Z-0275-2027 | IL | 2026-10-28 |
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