- Recalling firm
- Medline Industries, LP
- Reason for recall
- Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
- Affected products (lot / model / serial)
- UDI/DI 10195327005412 (each) 40195327005413 (case), Lot number 23JMA378
- Units affected
- 56 kits
- Distribution pattern
- US Nationwide distribution.
- Firm location
- Northfield, IL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0172-2027
- Recall initiated
- September 2, 2026
- FDA classification date
- October 15, 2026
- FDA report date
- October 21, 2026
- FDA event ID
- 99886
- Last updated on HTM Vibe
- October 27, 2026
