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U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0268-2027%22

Class II recall Z-0268-2027: Solstice Corporation

Q: How to monitor Class II recall Z-0268-2027: Solstice Corporation and peer other records

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Class II recall Z-0268-2027: Solstice Corporation (Maine): Solstice Corporation. Dated 8 days ago, it is in the active follow-up window. Score 68/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-04 · 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: 1 related ME FDAPulse records and the 5-column CSV export.

Field	Value
Record	Device recall
Recall number	Z-0268-2027
Recalling firm	Solstice Corporation
Classification	Class II
Status	Ongoing
Voluntary / mandated	Voluntary: Firm initiated
Specialty	Other
Product	Xact mole marker for mammography Model/Catalog Number: M15RM
Reason	The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material.
Quantity	736
Distribution	Worldwide - US Nationwide distribution in the states and territory of CA, FL, IL, IN, MN, MO, NY, OH, PA, TX, WV and Puerto Rico. The country of Canada.
Recall initiated	2026-09-22
Reported	2026-10-28
Firm location	South Portland, ME, United States
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-10-28
Data refreshed: 2026-11-04
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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 II recall Z-0268-2027: Solstice Corporation and 2 Maine peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

Maine FDAPulse records like this one: 2
Timing: Medium: dated in the last 30 days
Estimated pipeline if you contact every Maine peer: $400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

68 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Class II recall: usually triggers CAPA and quality-system remediation work.
Recall is still ongoing.
Posted 8 days ago.

What is the FDAPulse record for Class II recall Z-0268-2027: Solstice Corporation in Maine?

Class II device recall Z-0268-2027 by Solstice Corporation: The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached mat

How does Class II recall Z-0268-2027: Solstice Corporation compare to other Maine FDAPulse records?

It is fresh: dated 8 days ago, inside the window where early outreach matters most.

Class II recall Z-0268-2027 vs. top 3 peers

Organization	Location	Record date
Class II recall Z-0268-2027	ME	2026-10-28
Class II recall Z-3155-2026	MA	2026-10-07
Class II recall Z-0232-2027		2026-10-28
Class II recall Z-0243-2027		2026-10-28

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