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FDA recall, , Moderate risk

Medline Medical Convenience Kits

Medline medical convenience kits may be contaminated with low levels of Bacillus species.

What happened

Medline Industries, LP, of Northfield, Illinois, is recalling specific Medline medical convenience kits containing BD PurPrep 26 mL, which may be contaminated with low levels of Bacillus species. The recall began June 11, 2026, and was added to the FDA's Enforcement Report on July 23, 2026.

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is your kit affected?

Match the list below, then check the codes the FDA notice also names.

A UDI-DI is the device identifier printed with the barcode on the device label.

  1. Medline medical convenience kits

    1. UDI-DI
      • 10198459187780
      • 40198459187781
      • 10198459179235
      • 40198459179236
      • 10198459377600
      • 40198459377601
      Lot code
      • 25GBE239
      • 24LBF187
      • 25ABM992
      • 25CBJ129
      • 25DBI743
      • 24KBK487
      • 25FBU802
    2. UDI-DI
      • 10193489317244
      • 40193489317245
      • 10193489317183
      • 40193489317184
      • 10195327671808
      • 40195327671809
      • 10195327671723
      • 40195327671724
      • 10198459130977
      • 40198459130978
      • 10198459129889
      • 40198459129880
      • 10198459320491
      • 40198459320492
      • 10198459050671
      • 40198459050672
      • 10198459050688
      • 40198459050689
      Lot code
      • 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
      • 25FBF363
    3. UDI-DI
      • 10198459346873
      • 40198459346874
      • 10198459213342
      • 40198459213343
      Lot code
      • 25FBR237
      • 25ABM761
      • 25BBD107
      • 25FBD534
      • 25FBL772
    4. UDI-DI
      • 10198459098109
      • 40198459098100
      Lot code
      • 25AMJ225
      • 25CMF838
      • 24KME164
      • 25DMB248
      • 25FMD941
      • 25GMB662
      • 25GMG296

From the FDA notice

1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B;

2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A.

Recall details

Company began the recall
Company
Medline Industries, LPNorthfield, Illinois
Risk

Moderate risk

Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.

FDA Class II recall · How risk is rated

Event ID
99329
Recall numbers
Z-2788-2026 to Z-2791-2026

All recalls from Medline Industries, LP

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

  5. Summary updated

Summary by Recall Canary, written with AI · summary updated Oct 2, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)