Class II recall Z-3253-2026: Criticare Technologies, Inc.
Class II recall Z-3253-2026: Criticare Technologies, Inc. (Rhode Island): Criticare Technologies, Inc. Dated 35 days ago, it serves as a historical benchmark. Score 62/100. 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: 1 related RI FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3253-2026 |
| Recalling firm | Criticare Technologies, Inc. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, CAT 8100EP1-ST-US, CAT 8100EP1-US, CAT 8100EP1R |
| Reason | Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay. |
| Quantity | 1,007 |
| Distribution | US Nationwide distribution including in the states and territory of AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NH, NJ, NV, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and Puerto Rico. |
| Recall initiated | 2026-05-06 |
| Reported | 2026-09-30 |
| Firm location | Warwick, RI, United States |
| Peer records CSV (2 RI records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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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: 2026-09-30
- 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 II recall Z-3253-2026: Criticare Technologies, Inc. and 2 Rhode Island peers
- Rhode Island FDAPulse records like this one: 2
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Rhode Island peer: $400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
62 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 35 days ago.
What is the FDAPulse record for Class II recall Z-3253-2026: Criticare Technologies, Inc. in Rhode Island?
Class II device recall Z-3253-2026 by Criticare Technologies, Inc.: Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable
How does Class II recall Z-3253-2026: Criticare Technologies, Inc. compare to other Rhode Island FDAPulse records?
It is 35 days old, still within a typical 45-day follow-up window.
Class II recall Z-3253-2026 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-3253-2026 | RI | 2026-09-30 |
| 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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