# Class II recall Z-0169-2027: Medline Industries, LP

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0169-2027 |
| Recalling firm | Medline Industries, LP |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | 1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I;   2) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528N;   3) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528O;   4) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528P;   5) Product Name CATH LAB ENDO AAA, Medline Kit Number/SKU DYNJ35312J;   6) Product Name CATH LAB ENDO AAA, Medline Kit Number/SKU DYNJ35312K;   7) Product Name OPEN HEART PACK, Medline Kit Number/SKU DYNJ43937;   8) Product Name OPEN HEART PACK, Medline Kit Number/SKU DYNJ80549D;   9) Product N |
| Reason | Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use. |
| Quantity | 1834 kits |
| Distribution | US Nationwide distribution. |
| Recall initiated | 2026-09-02 |
| Reported | 2026-10-21 |
| Firm location | Northfield, IL, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 15 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-0169-2027%22). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.