(1) Nurse Kit, SKU #EDUC1025, Case UPC 40195327196647, Non-sterile,… — Class I medical device recall Z-0563-2024
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-01-03, distributed nationwide. The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use a
| Recall number | Z-0563-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2023-10-16 |
| Classified | 2023-12-22 |
| Reported by FDA | 2024-01-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, PA |
| Quantity | 550 kits |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 40195327153695, 40195327196647 |
| Lot numbers | 22HDA420, 22HDC201, 22HDC340, 22JDB315 |
Product
(1) Nurse Kit, SKU #EDUC1025, Case UPC 40195327196647, Non-sterile, For Training Purposes Only, Not For Human Use.; and (2) Nursing Tote Kit, SKU #EDUC5056A, Case UPC 40195327153695, Non-sterile, For Training Purposes Only, Not For Human Use.
Reason for recall
The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally, there have been incidents of the tracheostomy brush bristles detaching prior to use in the packaging and/or during use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0563-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.