Recall of Medline Heart Transplant Biopsy Kits
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Medline Industries is voluntarily recalling 39 units of Heart Transplant Biopsy kits due to rescinded regulatory clearances for certain components.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 7, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Medline Industries, LP is recalling the product because the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Which Products Are Affected
The affected product is Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A. The recall involves 39 units with UDI-DI: 10193489919561 (each) and 40193489919562 (case), and Lot Number: 24DDA193. Distribution was nationwide in the United States.
What You Should Do
Consumers should follow the initial firm notification, which was sent via letter, and contact Medline Industries, LP at their address: 3 Lakes Dr, Northfield, IL 60093-2753 for further instructions on returns or refunds. The official recall number is Z-1838-2026.
Why This Matters
This recall affects medical devices and could impact patient safety due to the rescinded clearances, highlighting the importance of regulatory compliance in healthcare products.
Source
Attribution: FDA. For more information, refer to the FDA recall notice at the agency's website.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,075 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.