FDA-Device2026-07-29Class IIPROCESSING DEFECT

Medline surgical convenience kits recalled for potential Bacillus contamination

Medline surgical kits recalled for Bacillus contamination risk

Medline Industries is recalling nine types of surgical convenience kits that contain BD PurPrep solution. The solution may be contaminated with low levels of Bacillus species, a bacterium that could pose a risk if the kits are used in sterile procedures. The recall affects specific lot numbers of joint, spine, and neurological surgery kits distributed to hospitals and surgical centers in ten U.S. states.

  • Check if your facility has any of the affected Medline kit SKUs listed in this recall.
  • Do not use kits with the affected lot numbers.
  • Contact Medline Industries or your supplier for instructions on returning affected kits.
  • Review your records to identify which patients may have received care with affected kits.
Hazard

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.

Sold states
US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.
Affected count
1601 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2791-2026

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