Class I — MEDLINE INDUSTRIES, LP - Northfield
| Recalling firm | Medline Industries, LP |
|---|---|
| Registered facility | View this company's 31 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | 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. |
| 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. |
| Quantity | 550 kits |
| Distribution | US Nationwide distribution including Puerto Rico. OUS (Foreign) distribution was made to Canada, Panama, and United Arab Emirates. |
| Initiated | 2023-10-16 |
| Classified | 2023-12-22 |
| Recall number | Z-0563-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — MEDLINE INDUSTRIES, LP - Northfield (Z-0563-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93327/
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