Medline Convenience Kits Recalled Over Bacillus Contamination
Medline Industries, LP is recalling 1601 units of specific Medline convenience kits that may be contaminated with low levels of Bacillus species. The recall affects kits distributed across multiple US states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving potential microbial contamination (Bacillus species) in medical device kits used in surgical procedures. While no illnesses or injuries have been reported, the contamination of medical devices used in invasive procedures poses a risk of harm, meeting the rubric criterion for High severity (risk-of-harm products where injury has not yet been reported).
Plain-English summary
Medline Industries, LP is recalling specific Medline medical convenience kits that contain BD PurPrep 26 mL, which may be contaminated with low levels of Bacillus species. The affected kits include TOTAL JOINT PACK, EXTREMITY/FOOT PACK, ANTERIOR CERVICAL-SMH, LAMINECTOMY-SMH, KYPHOPLASTY, LUMBAR LAMINECTOMY, KYPHOPLASTY TRAY, CRANIOTOMY, and NEURO SPINE Medline Kits.
A total of 1601 units are included in this recall. The affected products were distributed across the following US states: CT, FL, KS, OH, OR, NY, MD, MT, VA, and MA.
The recall is being issued because the BD PurPrep 26 mL component in these kits may be contaminated with low levels of Bacillus species, which could pose a risk to patients if used in medical procedures.
Healthcare facilities and distributors who received the affected kits should follow their internal procedures for recalled medical devices and contact Medline Industries, LP for instructions on returning or replacing the affected products. Consumers with questions should contact their healthcare provider or Medline directly.
The recalled product
- 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
- Manufacturer
- Medline Industries, LP
- Hazard
- bacterial-contamination
- bacillus
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Medline Kit SKU DYNJ65065A
- UDI/DI 10193489317244 (each) 40193489317245 (case)
- Lot Number 24KMI926
- Lot Number 25BMI009
- Lot Number 25DME458
- Lot Number 25FMC143
- Medline Kit SKU DYNJ65066B
- UDI/DI 10193489317183 (each) 40193489317184 (case)
- Lot Number 24KME109
- Lot Number 24LMD416
- Lot Number 25BMB162
- Lot Number 25DMB403
- Lot Number 25DMK347
- Lot Number 25FMA695
- Medline Kit SKU DYNJ907718B
- UDI/DI 10195327671808 (each) 40195327671809 (case)
- Lot Number 25ABJ808
- Lot Number 25ABM644
- Lot Number 25BBT262
- Medline Kit SKU DYNJ907732C
Distribution
Distributed in 10 states:
- CT
- FL
- KS
- MA
- MD
- MT
- NY
- OH
- OR
- VA
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