# Class II recall Z-0155-2027: Steris Corporation

**Predicate Speed & CAPA Advisory Opportunity Score:** 68/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0155-2027 |
| Recalling firm | Steris Corporation |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116 |
| Reason | If the vented cap becomes blocked, gas may accumulate  and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity. |
| Quantity | 11806 units |
| Distribution | Worldwide - US Nationwide distribution. |
| Recall initiated | 2026-09-21 |
| Reported | 2026-10-21 |
| Firm location | Mentor, OH, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 14 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0155-2027%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.