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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-0202-2027%22

Class II recall Z-0202-2027: Beckman Coulter, Inc.

Q: How to monitor Class II recall Z-0202-2027: Beckman Coulter, Inc. and peer other records

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Class II recall Z-0202-2027: Beckman Coulter, Inc. (Indiana): Beckman Coulter, Inc. 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: 12 related IN FDAPulse records and the 5-column CSV export.

Field	Value
Record	Device recall
Recall number	Z-0202-2027
Recalling firm	Beckman Coulter, Inc.
Classification	Class II
Status	Ongoing
Voluntary / mandated	Voluntary: Firm initiated
Specialty	Other
Product	ROTOR ASSY-SW41, Reference Number 331362, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846 and A94469), Optima XPN-90 (Model Numbers A99842 and A94468), Optima XPN-80 (Model Numbers A99839 and A95765), Optima XE-100 (Model Numbers A99836 and A94516), and Optima XE-90 (Model Numbers A99833 and A94471)
Reason	Rotors have been found with a non-conforming microstructure, which may result in some rotors breaking into two or more pieces during use. Rotors that break into multiple pieces during use may result in significant damage to materials (i.e., samples) being processed in the centrifuge and to the centrifuge instrument.
Quantity	336 units
Distribution	US Nationwide distribution.
Recall initiated	2026-09-21
Reported	2026-10-28
Firm location	Indianapolis, IN, 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-0202-2027: Beckman Coulter, Inc. and 13 Indiana peers

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

Indiana FDAPulse records like this one: 13
Timing: Medium: dated in the last 30 days
Estimated pipeline if you contact every Indiana peer: $2,600 (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-0202-2027: Beckman Coulter, Inc. in Indiana?

Class II device recall Z-0202-2027 by Beckman Coulter, Inc.: Rotors have been found with a non-conforming microstructure, which may result in some rotors breaking into two or more p

How does Class II recall Z-0202-2027: Beckman Coulter, Inc. compare to other Indiana FDAPulse records?

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

Class II recall Z-0202-2027 vs. top 3 peers

Organization	Location	Record date
Class II recall Z-0202-2027	IN	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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