Medline Industries, Lp: Orthopedic Tray
Medline Industries is recalling nine types of surgical convenience kits used in orthopedic and spine procedures because they may contain low levels of Bacillus bacteria contamination in the BD PurPrep solution included in the kits. The affected kits were distributed to hospitals and medical facilities in Connecticut, Florida, Kansas, Maryland, Massachusetts, Montana, New York, Ohio, Oregon, and Virginia. This is a Class I recall, which is the most serious classification.
- Recalling firm
- Medline Industries, LP
- Product
- 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.
- Reason
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-11
- Status
- Open, Classified
- Areas affected
- CT, FL, KS, MD, MA, MT, NY, OH, OR, VA
- Distribution
- US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/6768f010-76c5-4c02-9307-646322c8c29b