FDA Medical devices recall ·
Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A recall
- Recall number
- Z-1838-2026
- Date
- (initiated February 25, 2026)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 39 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
Why was it recalled?
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1) DYNJ37543A, UDI-DI: 10193489919561(each), 40193489919562(case), Lot Number: 24DDA193
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1838-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.