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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-0161-2027%22

Class II recall Z-0161-2027: Beckman Coulter, Inc.

Q: How to monitor Class II recall Z-0161-2027: Beckman Coulter, Inc. and peer other records

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Class II recall Z-0161-2027: Beckman Coulter, Inc. (Florida): Beckman Coulter, 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 2026-11-03 · 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: 15 related FL FDAPulse records and the 5-column CSV export.

Field	Value
Record	Device recall
Recall number	Z-0161-2027
Recalling firm	Beckman Coulter, Inc.
Classification	Class II
Status	Ongoing
Voluntary / mandated	Voluntary: Firm initiated
Specialty	Other
Product	IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997; IQ200 SELECT, REF: 700-3340, 700-3345, 700-3347, B48998, C10684; IQ200 ELITE, REF: 700-3370, 700-3375, 700-3375RFB, 700-3376, B48999, C10683
Reason	The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual preventive maintenance (PM) requirements without adequate reliability evaluation. When the check valve is not replaced annually, it may allow lamina fluid to migrate internally and leak onto the table or floor, potentially resulting in exposure to physical hazards (slip/fall), chemical hazards (lamina fluid exposure), biohazardous exposure, property damage, and delayed patient results.
Distribution	Worldwide - US Nationwide distribution including in the states and territory of CA, NE, FL, NY, MA, MD, SC, WI, TX, OH, VA, PA, IL, NH, KS, GA, NC, IA, PR, TN, OR, UT, NJ, MI, CO, NM, MS, LA, RI, OK, WA, MO, ME, IN, CT, AZ, AR, MT, MN, ID, DE, AL, WV, DC, KY, NV, WY, ND, HI, AK, SD, VT, GU and the c
Recall initiated	2026-08-12
Reported	2026-10-21
Firm location	Miami, FL, United States
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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: 2026-10-21
Data refreshed: 2026-11-03
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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-0161-2027: Beckman Coulter, Inc. and 16 Florida peers

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

Florida FDAPulse records like this one: 16
Timing: Medium: dated in the last 30 days
Estimated pipeline if you contact every Florida peer: $3,200 (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 14 days ago.

What is the FDAPulse record for Class II recall Z-0161-2027: Beckman Coulter, Inc. in Florida?

Class II device recall Z-0161-2027 by Beckman Coulter, Inc.: The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to p

How does Class II recall Z-0161-2027: Beckman Coulter, Inc. compare to other Florida FDAPulse records?

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

Class II recall Z-0161-2027 vs. top 3 peers

Organization	Location	Record date
Class II recall Z-0161-2027	FL	2026-10-21
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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