Z-2791-2026Class II

Medline Industries, LP

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Device

Status

Ongoing

Report date

2026-07-29

Distribution

US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.

Firm state

Product quantity

1601 units

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Environmental Monitoring

Reason for recall

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.

Product description

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.

Code / lot 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.

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See all Environmental Monitoring recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →