Class II recall Z-0187-2027: Merit Medical Systems, Inc.

Class II recall Z-0187-2027: Merit Medical Systems, Inc. (Utah): Merit Medical Systems, Inc. Dated 14 days ago, it is in the active follow-up window. Score 68/100. 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 13 published fields of this record are shown below. Locked: 10 related UT FDAPulse records and the 5-column CSV export.

FieldValue
RecordDevice recall
Recall numberZ-0187-2027
Recalling firmMerit Medical Systems, Inc.
ClassificationClass II
StatusOngoing
Voluntary / mandatedVoluntary: Firm initiated
SpecialtyOther
ProductScout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance System, Rx Only, Sterile-EO
ReasonThe implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.
DistributionUS: AZ, CA, FL, IN, LA, NV, RI OUS: None
Recall initiated2026-08-27
Reported2026-10-21
Firm locationSouth Jordan, UT, United States
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  • Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
  • Record date: 2026-10-21
  • 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-0187-2027: Merit Medical Systems, Inc. and 11 Utah peers

  • Utah FDAPulse records like this one: 11
  • Timing: Medium: dated in the last 30 days
  • Estimated pipeline if you contact every Utah peer: $2,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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68 / 100 Predicate Speed & CAPA Advisory Opportunity Score

  • Class II recall: usually triggers CAPA and quality-system remediation work.
  • Recall is still ongoing.
  • Posted 14 days ago.

What is the FDAPulse record for Class II recall Z-0187-2027: Merit Medical Systems, Inc. in Utah?

Class II device recall Z-0187-2027 by Merit Medical Systems, Inc.: The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intend

How does Class II recall Z-0187-2027: Merit Medical Systems, Inc. compare to other Utah FDAPulse records?

It is fresh: dated 14 days ago, inside the window where early outreach matters most.

Class II recall Z-0187-2027 vs. top 3 peers

OrganizationLocationRecord date
Class II recall Z-0187-2027UT2026-10-21
Class II recall Z-3155-2026MA2026-10-07
Class II recall Z-0232-20272026-10-28
Class II recall Z-0243-20272026-10-28

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