- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.
- Affected products (lot / model / serial)
- GTIN 00840253111012, Lot 38400303, Exp. January 20, 2029
- Units affected
- 9750 units
- Distribution pattern
- US Nationwide distribution.
- Firm location
- Marlborough, MA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2413-2026
- Recall initiated
- May 12, 2026
- FDA classification date
- June 11, 2026
- FDA report date
- June 17, 2026
- FDA event ID
- 98970
- Last updated on HTM Vibe
- July 23, 2026