Class II U.S. Food and Drug Administration

Medline medical convenience kits labeled as: 1) Total Joint Pack recall: Medline Industries, LP is issuing a recall for specific Medline convenience

Recall published 3 months ago

Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2791-2026
Published
July 29, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medline Industries, LP
Product type
Medical devices
Units affected
1601 units
Distribution
Connecticut, Florida, Kansas, Massachusetts, Maryland, Montana, New York, Ohio, Oregon, Virginia
Made in
United States
Lot / code info
Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case), Lot Number 24KMI926; Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case), Lot Number 25BMI009; Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case), Lot Number 25DME458; Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case), Lot Number 25FMC143; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 24KME109; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 24LMD416; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 25BMB162; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 25DMB403; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 25DMK347; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 25FMA695; Medline Kit SKU DYNJ907718B, UDI/DI 10195327671808 (each) 40195327671809 (case), Lot Number 25ABJ808; Medline Kit SKU DYNJ907718B, UDI/DI 10195327671808 (each) 40195327671809 (case), Lot Number 25ABM644; Medline Kit SKU DYNJ907718B, UDI/DI 10195327671808 (each) 40195327671809 (case), Lot Number 25BBT262; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 24LBD661; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 25ABP134; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 25BBS412; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 25DBS673; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 25FBS372; Medline Kit SKU DYNJ907984C, UDI/DI 10198459130977 (each) 40198459130978 (case), Lot Number 25CBO351; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 24LBO744; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25ABD265; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25CBD596; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25CBO352; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25EBB260; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25EBV317; Medline Kit SKU DYNJ908413C, UDI/DI 10198459320491 (each) 40198459320492 (case), Lot Number 25EBD582; Medline Kit SKU DYNJ908413C, UDI/DI 10198459320491 (each) 40198459320492 (case), Lot Number 25FBM835; Medline Kit SKU DYNJ910626, UDI/DI 10198459050671 (each) 40198459050672 (case), Lot Number 25DBC117; Medline Kit SKU DYNJ910626, UDI/DI 10198459050671 (each) 40198459050672 (case), Lot Number 25DBE196; Medline Kit SKU DYNJ910626, UDI/DI 10198459050671 (each) 40198459050672 (case), Lot Number 25FBL400; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 24LBD222; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 24LBN441; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 25ABL748; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 25EBF179; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 25FBF363.
UPC codes
10193489317244, 40193489317245, 10193489317183, 40193489317184, 10195327671808, 40195327671809, 10195327671723, 40195327671724, 10198459130977, 40198459130978, 10198459129889, 40198459129880, 10198459320491, 40198459320492, 10198459050671, 40198459050672, 10198459050688, 40198459050689

Products covered by this recall

Medline medical convenience kits labeled as: 1) TOTAL JOINT PACK Medline Kit SKU DYNJ65065A: 2) EXTREMITY/FOOT PACK Medline Kit SKU DYNJ65066B: 3) ANTERIOR CERVICAL-SMH Medline Kit SKU DYNJ907718B: 4) LAMINECTOMY-SMH Medline Kit SKU DYNJ907732C: 5) KYPHOPLASTY Medline Kit SKU DYNJ907984C: 6) LUMBAR LAMINECTOMY Medline Kit SKU DYNJ907987D: 7) KYPHOPLASTY TRAY Medline Kit SKU DYNJ908413C: 8) CRANIOTOMY Medline Kit SKU DYNJ910626: 9) NEURO SPINE Medline Kit SKU DYNJ910639.

Check your product

The notice names 58 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10193489317244
  • 40193489317245
  • 10193489317183
  • 40193489317184
  • 10195327671808
  • 40195327671809
  • 10195327671723
  • 40195327671724
  • 10198459130977
  • 40198459130978
  • 10198459129889
  • 40198459129880
  • 10198459320491
  • 40198459320492
  • 10198459050671
  • 40198459050672
  • 10198459050688
  • 40198459050689

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 24KMI926
  • 25BMI009
  • 25DME458
  • 25FMC143
  • 24KME109
  • 24LMD416
  • 25BMB162
  • 25DMB403
  • 25DMK347
  • 25FMA695
  • 25ABJ808
  • 25ABM644
  • 25BBT262
  • 24LBD661
  • 25ABP134
  • 25BBS412
  • 25DBS673
  • 25FBS372
  • 25CBO351
  • 24LBO744

Model or item number

On the rating label, the box or the instruction sheet.

  • DYNJ65065A
  • DYNJ65066B
  • DYNJ907718B
  • DYNJ907732C
  • DYNJ907984C
  • DYNJ907987D
  • DYNJ908413C
  • DYNJ910626
  • UDI
  • DI 10
  • DI 10193489317244
  • DI 10193489317183
  • DI 10195327671808
  • DI 10195327671723
  • DI 10198459130977
  • DI 10198459129889
  • DI 10198459320491
  • DI 10198459050671
  • DYNJ910639
  • DI 10198459050688

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Medline Industries, LP — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Medline Industries, LP — 3 Lakes Dr, Northfield, IL, 60093-2753

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medline Industries, LP medical devices recalled?

Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species. Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10193489317244, 40193489317245, 10193489317183; lot code 24KMI926, 25BMI009, 25DME458; model number DYNJ65065A, DYNJ65066B, DYNJ907718B. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Which states were affected?

The notice lists Connecticut, Florida, Kansas, Massachusetts, Maryland, Montana, New York, Ohio, Oregon, Virginia.

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