Class II recall Z-0071-2027: Steris Corporation
Class II recall Z-0071-2027: Steris Corporation (Ohio): Steris Corporation. Dated 21 days ago, it is in the active follow-up window. 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: 24 related OH FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0071-2027 |
| Recalling firm | Steris Corporation |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007 |
| Reason | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction |
| Quantity | 409 |
| Distribution | Worldwide - US Nationwide distribution. |
| Recall initiated | 2026-08-31 |
| Reported | 2026-10-14 |
| Firm location | Mentor, OH, United States |
| Peer records CSV (25 OH records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch Class II recall Z-0071-2027: Steris Corporation
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 OH records
See the real columns before you buy. One confirmation email, nothing else unless you opt in.
Unlock Class II recall Z-0071-2027: Steris + all 25 OH 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: 2026-10-14
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (OH first): Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope ( · MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor ( · Intra-Operative Positioning System (IOPS) and IOPS Visionary · ACHM30 AtriClip FLEX-Mini LAA Exclusion System (K263319) · Class II recall Z-0145-2027 · Browse all by state and category →
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
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-0071-2027: Steris Corporation and 25 Ohio peers
- Ohio FDAPulse records like this one: 25
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Ohio peer: $5,000 (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 21 days ago.
What is the FDAPulse record for Class II recall Z-0071-2027: Steris Corporation in Ohio?
Class II device recall Z-0071-2027 by Steris Corporation: Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. Wh
How does Class II recall Z-0071-2027: Steris Corporation compare to other Ohio FDAPulse records?
It is 21 days old, still within a typical 45-day follow-up window.
Class II recall Z-0071-2027 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-0071-2027 | OH | 2026-10-14 |
| 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 Ohio public-record feeds
New NSF Research Awards by Institution in Ohio Nonprofit Revenue, Expenses & Assets from Form 990 in Ohio New FDA Medical Device Listings by Manufacturer, CMO & Sterilizer in Ohio Newly CLIA-Certified Laboratories by State & Certificate in Ohio New & Re-Approved E-Rate Service Providers (FCC Form 498 / SPIN) in Ohio Largest U.S. Greenhouse Gas Emitters by Company, Sector & State (EPA GHGRP) in Ohio Newly Posted IRS Automatic Revocations of Tax Exemption in Ohio School & Library E-Rate Contracts Up for Rebid in Ohio
How to monitor Class II recall Z-0071-2027: Steris Corporation and peer other records
Get new FDAPulse records like Class II recall Z-0071-2027: Steris Corporation 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.