Medline Kits: 1) HEART TRANSPLANT BIOPSY — Class II medical device recall Z-1838-2026
Ongoing recall by Medline Industries, LP, reported 2026-04-29, distributed nationwide. The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have be
| Recall number | Z-1838-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-02-25 |
| Classified | 2026-04-17 |
| Reported by FDA | 2026-04-29 |
| Distributed | Nationwide (US) |
| Quantity | 39 units |
| UPC / GTIN / UDI-DI | 10193489919561, 40193489919562 |
| Lot numbers | 24DDA193 |
| Model numbers | DYNJ37543A |
Product
Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
Reason for recall
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
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-1838-2026. 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.