- Recalling firm
- Medline Industries, LP
- Reason for recall
- The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- Affected products (lot / model / serial)
- 1) DYNJ48399C, UDI-DI: 10195327172626(each), 40195327172627(case), Lot Number: 24CBU779; 2) DYNJ62849B, UDI-DI: 10195327514884(each), 40195327514885(case), Lot Number: 24BBS275
- Units affected
- 89 units
- Distribution pattern
- US Nationwide distribution.
- 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-1847-2026
- Recall initiated
- February 25, 2026
- FDA classification date
- April 17, 2026
- FDA report date
- April 29, 2026
- FDA event ID
- 98599
- Last updated on HTM Vibe
- July 24, 2026