Class II recall Z-0204-2027: CooperVision, Inc.
Class II recall Z-0204-2027: CooperVision, Inc. (New York): CooperVision, 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 · 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: 6 related NY FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0204-2027 |
| Recalling firm | CooperVision, Inc. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Generic Name: Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic) Contact Lens; Model/Catalog Number: Softmed Breathables Advanced Toric Product Description: 55% water content, toric, silicone hydrogel contact lens for daily wear, frequent replacement. Blister packaged. |
| Reason | The affected products bear an incorrect statement on the carton packaging indicating that the product is "Indicated for Extended Wear". However, this product is intended for daily wear, and the extended-wear statement should not have appeared on the affected carton labeling. This product is not approved by the U.S. Food and Drug Administration (FDA) for extended wear use. |
| Quantity | 230856 |
| Distribution | US Nationwide distribution in the states of FL, KY, MI. |
| Recall initiated | 2026-09-22 |
| Reported | 2026-10-28 |
| Firm location | West Henrietta, NY, United States |
| Peer records CSV (7 NY records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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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
- 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-0204-2027: CooperVision, Inc. and 7 New York peers
- New York FDAPulse records like this one: 7
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every New York peer: $1,400 (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-0204-2027: CooperVision, Inc. in New York?
Class II device recall Z-0204-2027 by CooperVision, Inc.: The affected products bear an incorrect statement on the carton packaging indicating that the product is "Indicated for
How does Class II recall Z-0204-2027: CooperVision, Inc. compare to other New York FDAPulse records?
It is fresh: dated 8 days ago, inside the window where early outreach matters most.
Class II recall Z-0204-2027 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-0204-2027 | NY | 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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