# Class II recall Z-0179-2027: Medline Industries, LP

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

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0179-2027 |
| Recalling firm | Medline Industries, LP |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Medline surgical convenience kits labeled as:    1) SPINAL CDS, Medline Product Number/SKU CDS940087AM;   2) CUSTOM CRANI, Medline Product Number/SKU DYNJ907697C;   3) FEM POP PACK-LF, Medline Product Number/SKU DYNJ0159820F;   4) AV FISTULA PACK, Medline Product Number/SKU DYNJ67139D;   5) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AD;   6) LAMINECTOMY PACK, Medline Product Number/SKU DYNJ17333K;   7) EXTREMITY-LF, Medline Product Number/SKU DYNJ905276F;   8) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AC;   9) SPINAL CDS, Medline Product Number/SKU CDS940087AL;   10) CUSTOM  |
| 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 | 6069 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-0179-2027%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.