CLASS II ONGOING Device recall · Reported 29 Apr 2026 · FDA Enforcement Report
Medline Kits: Heart Transplant Biopsy recalled by Medline Industries
Medline Industries is recalling Medline Kits: Heart Transplant Biopsy, distributed nationwide in the US. The recall was initiated on 25 Feb 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1838-2026
- FDA event ID
- 98599
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Feb 2026
- FDA classified
- 17 Apr 2026
- Reported
- 29 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 25 Feb 2026 | Recall initiated by company | |
| 17 Apr 2026 | Classified by FDA | +51 days |
| 29 Apr 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Product as listed by the FDA
Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Which lots are affected?
1) DYNJ37543A, UDI-DI: 10193489919561(each), 40193489919562(case), Lot Number: 24DDA193
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
21 other products · FDA event 98599More recalls from Medline Industries
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