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Medline Pediatric Open Heart Kit
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MEDICAL DEVICE RECALLMODERATE

Medline Pediatric Open Heart Kit

Medline is recalling convenience kits containing BD PurPrep 26 mL over possible Bacillus contamination.

What to do

Check whether your kit is one of the affected SKUs (DYNJ910103B or DYNJ910961A). If so, stop using the kit and contact Medline Industries, LP for instructions on returning the product and obtaining a replacement or refund.

Recalled
Listed
Updated
Recall No.
Z-2788-2026
Agency
FDA
Firm
Medline Industries, LP
Recall ID
99329
Status
ONGOING

Why it was recalled

Medline Industries, LP is recalling specific Medline convenience kits that contain BD PurPrep 26 mL, which may be contaminated with low levels of Bacillus species. The affected kits are the KIT PEDIATRIC OPEN HEART MOSES (SKU DYNJ910103B) and the BASIC HEART CDS (SKU DYNJ910961A).

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Medline medical convenience kits labeled as

Lot codeRecall #UDI-DI
25GBE239, 24LBF187, 25ABM992, 25CBJ129, 25DBI743, 24KBK487, 25FBU802Z-2789-202610198459187780, 40198459187781, 10198459187780, 40198459187781, 10198459187780, 40198459187781, 10198459187780, 40198459187781, 10198459187780, 40198459187781, 10198459179235, 40198459179236, 10198459377600, 40198459377601
24KMI926, 25BMI009, 25DME458, 25FMC143, 24KME109, 24LMD416, 25BMB162, 25DMB403, 25DMK347, 25FMA695, 25ABJ808, 25ABM644, 25BBT262, 24LBD661, 25ABP134, 25BBS412, 25DBS673, 25FBS372, 25CBO351, 24LBO744, 25ABD265, 25CBD596, 25CBO352, 25EBB260, 25EBV317, 25EBD582, 25FBM835, 25DBC117, 25DBE196, 25FBL400, 24LBD222, 24LBN441, 25ABL748, 25EBF179, 25FBF363Z-2791-202610193489317244, 40193489317245, 10193489317244, 40193489317245, 10193489317244, 40193489317245, 10193489317244, 40193489317245, 10193489317183, 40193489317184, 10193489317183, 40193489317184, 10193489317183, 40193489317184, 10193489317183, 40193489317184, 10193489317183, 40193489317184, 10193489317183, 40193489317184
25FBR237, 25ABM761, 25BBD107, 25FBD534, 25FBL772Z-2788-202610198459346873, 40198459346874, 10198459213342, 40198459213343, 10198459213342, 40198459213343, 10198459213342, 40198459213343, 10198459213342, 40198459213343
25AMJ225, 25CMF838, 24KME164, 25DMB248, 25FMD941, 25GMB662, 25GMG296Z-2790-202610198459098109, 40198459098100

Where it was sold

Distributed in Connecticut, Florida, Kansas, Massachusetts, Maryland, Montana, New York, Ohio, Oregon, and Virginia.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification