- Recalling firm
- Medline Industries, LP
- Reason for recall
- Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.
- Affected products (lot / model / serial)
- UDI-DI 10198459020612 Lot 25GBP246
- Units affected
- 336
- Distribution pattern
- US Nationwide distribution in states of Arkansas, Florida, North Carolina, Maryland, and Texas.
- Firm location
- Northfield, IL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3210-2026
- Recall initiated
- July 31, 2026
- FDA classification date
- September 16, 2026
- FDA report date
- September 23, 2026
- FDA event ID
- 99667
- Last updated on HTM Vibe
- September 29, 2026