Class I recall Z-3227-2026: Medline Industries, LP

Class I recall Z-3227-2026: Medline Industries, LP (Illinois): Medline Industries, LP. Dated 28 days ago, it is in the active follow-up window. Score 76/100. As of 2026-11-04, 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.

FieldValue
RecordDevice recall
Recall numberZ-3227-2026
Recalling firmMedline Industries, LP
ClassificationClass I
StatusOngoing
Voluntary / mandatedVoluntary: Firm initiated
SpecialtyOther
ProductMedline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants: MDR510094 PENDANT F/ MDR107002E MDR520094 PENDANT F/ MDR107003E MDR530094 PENDANT, W/ 9V BATTERY BACKUP, F/ 2E BED MDR540094 PENDANT, W/ 9V BATTERY BACKUP, F/ 3E BED
ReasonPotential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, sparking, melting, burning, or fire. Additional products added to 11/26/2025 recall.
Quantity771,127 total
DistributionDistribution US Nationwide including territories of Puerto Rico and Guam and the countries of Bermuda, Canada, and Panama.
Recall initiated2026-08-14
Reported2026-10-07
Firm locationNorthfield, IL, United States
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  • Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
  • Record date: 2026-10-07
  • Data refreshed: 2026-11-04
  • 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: Wed, 04 Nov 2026 09:16:12 GMT

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Peer benchmark and outreach value: Class I recall Z-3227-2026: 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)

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76 / 100 Predicate Speed & CAPA Advisory Opportunity Score

  • Class I recall: the most serious category, typically requiring urgent corrective and preventive action (CAPA).
  • Recall is still ongoing.
  • Posted 28 days ago.

What is the FDAPulse record for Class I recall Z-3227-2026: Medline Industries, LP in Illinois?

Class I device recall Z-3227-2026 by Medline Industries, LP: Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or penda

How does Class I recall Z-3227-2026: Medline Industries, LP compare to other Illinois FDAPulse records?

It is 28 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 76/100 puts it among the stronger signals in this feed.

Class I recall Z-3227-2026 vs. top 3 peers

OrganizationLocationRecord date
Class I recall Z-3227-2026IL2026-10-07
Class I recall Z-0127-2027WA2026-10-28
Class I recall Z-0132-2027WA2026-10-28
Class I recall Z-0131-2027WA2026-10-28

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