Class II recall Z-0163-2027: Cook Incorporated
Class II recall Z-0163-2027: Cook Incorporated (Indiana): Cook Incorporated. 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 · 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-0163-2027 |
| Recalling firm | Cook Incorporated |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part Number 090001-S26, Order Number (GPN) G16112 |
| Reason | The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential events that may occur as a result of this issue include increased procedural time and inadequate treatment. |
| Quantity | 97 units |
| Distribution | US States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain, Switzerland. |
| Recall initiated | 2026-09-16 |
| Reported | 2026-10-21 |
| Firm location | Bloomington, IN, United States |
| Peer records CSV (13 IN records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch Class II recall Z-0163-2027: Cook Incorporated
Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.
Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.
Free first: a 10-record sample of IN records
See the real columns before you buy. One confirmation email, nothing else unless you opt in.
Unlock Class II recall Z-0163-2027: Cook + all 13 IN records (CSV)
Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
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
- Refunds on request within 14 days
Top FDAPulse records (IN first): Kentrospine Viktr-MIS® Pedicle screw system (K252139) · Elecsys EBV EBNA IgG (K260221) · Elecsys EBV VCA IgG (K260232) · Elecsys EBV IgM (K260233) · Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Lue · Browse all by state and category →
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
Is this your business? Add a "Listed on Zalwin" badge to your site
Paste this snippet into your website. It links to this public record; nothing is tracked on your site.
Peer benchmark and outreach value: Class II recall Z-0163-2027: Cook Incorporated and 13 Indiana peers
- 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 14 days ago.
What is the FDAPulse record for Class II recall Z-0163-2027: Cook Incorporated in Indiana?
Class II device recall Z-0163-2027 by Cook Incorporated: The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignmen
How does Class II recall Z-0163-2027: Cook Incorporated compare to other Indiana FDAPulse records?
It is fresh: dated 14 days ago, inside the window where early outreach matters most.
Class II recall Z-0163-2027 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-0163-2027 | IN | 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 |
Related records
- Class II recall Z-3155-2026: Philips North America Llc
- Class II recall Z-0232-2027: Boston Scientific Cork, Ltd.
- Class II recall Z-0243-2027: Boston Scientific Cork, Ltd.
- Class II recall Z-0258-2027: Boston Scientific Cork, Ltd.
- Class II recall Z-0211-2027: Life Technologies Holdings Pte Ltd
- Class II recall Z-0231-2027: Boston Scientific Cork, Ltd.
- Class II recall Z-0197-2027: Medtronic Navigation, Inc.
- Class II recall Z-0281-2027: Medline Industries, LP
- Class II recall Z-0229-2027: Boston Scientific Cork, Ltd.
- Class II recall Z-0196-2027: Medtronic Navigation, Inc.
- Class II recall Z-0275-2027: Medline Industries, LP
- Class II recall Z-0200-2027: Greiner Bio-One North America, Inc.
Recent FDA Class II device recalls
More Indiana public-record feeds
FEMA Hazard Mitigation Project Tracker in Indiana New MSHA Citations at Mines & Quarries by State in Indiana FMCSA Trucking Insurance Cancellations by Carrier, Insurer & Fleet Size in Indiana New FDA Medical Device Listings by Manufacturer, CMO & Sterilizer in Indiana SEC 8-K Corporate Trigger Events in Indiana New Grants by Vendor Procurement Need in Indiana HIPAA Breach Reports (500+ Individuals) by State & Type in Indiana New & Re-Approved E-Rate Service Providers (FCC Form 498 / SPIN) in Indiana
How to monitor Class II recall Z-0163-2027: Cook Incorporated and peer other records
Get new FDAPulse records like Class II recall Z-0163-2027: Cook Incorporated by email (free, weekly)
We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email.
Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe.
Get clearances and recalls like this every day
FDAPulse emails new 510(k) clearances and recalls for your specialties and competitors.
✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.
Often used together
- NPIPulse
- EPAPulse
- Municipal Public Works Prime Contract Operating Permit Renewal Pulse
- TrialRecruitmentPageAudit
- SubdomainShadowPulse
- MigrationSignalRadar
Or get the Healthcare Vendor Bundle for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.