- Recalling firm
- Intersurgical Inc
- Reason for recall
- Devices could potentially be occluded or partially occluded.
- Affected products (lot / model / serial)
- REF: 1000035; Single Unit UDI: 5030267049844; Case UDI: 05030267044528; Lot No. 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565.
- Units affected
- 1,575 units
- Distribution pattern
- US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.
- Firm location
- East Syracuse, NY, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2953-2026
- Recall initiated
- June 15, 2026
- FDA classification date
- August 14, 2026
- FDA report date
- August 26, 2026
- FDA event ID
- 99284
- Last updated on HTM Vibe
- September 8, 2026