- Recalling firm
- ConMed Corporation
- Reason for recall
- Potential for overpressure alerts.
- Affected products (lot / model / serial)
- Catalog Number: iAS8-100LP. UDI-DI: 10845854045718. Lot Numbers: 202509034, 202511194, 202509174, 202506264, 202506254, 202506274, 202507074, 202505096, 202507244, 202508124, 202508194, 202507084, 202504294, 202505074, 202504304, 202504155, 202505064, 202505094, 202505204, 202509244, 202511184, 2025102210, 202508254, 2025111110, 202510154, 202508054, 202508114, 202507254, 202509084, 202509054, 202411015, 202408155, 202503016, 202504234, 202505264, 202501134, 202411124, 202501135, 202412195, 202411305, 202511274, 202509274, 202511284, 202504284, 202504224, 202503194, 202504085, 202508184, 202510304, 202409034, 202409095, 202409094, 202408085, 202410104, 202506304, 202506054, 202510094, 202409025, 202410175, 202508264, 202408095, 202408125, 202411115, 202411014, 202506044, 202509194, 202511264, 202408274, 202412205, 202412025, 202501236, 202501235, 202501244, 202503156, 202503145, 202503144, 202504084, 202408094, 202408084, 202410105, 202502066, 202501094, 202509184, 202408275, 202408194, 202507144, 202507154, 202412024, 202501234, 202411295, 202504094, 202503196, 202503125, 202503126, 202503034, 202504145, 202408165, 2025081811, 202408154, 202503264, 202502055, 202411294, 202412106, 202601074, 2026010711, 202501225, 202412204, 202501245, 202409106, 202410315. *OUS added 06/10/2026 expansion:202408284, 202509244, 202507254, 202508054, 202508194, 202505064, 202504294, 202504155, 202504304, 202501085, 202501146, 202501274, 202501224, 202410314, 202410315, 202509034, 2025111110, 202509174, 202507244, 202508124, 202506274, 202505204, 202506254, 202503144, 202409106, 202511184, 202505096, 202501225, 202510154, 202408165, 202508114, 202508254, 202408085, 202507084, 202505094, 202507074, 202503194, 202501135, 202412205, 202412204, 202408084, 202411295, 202412106, 202509054, 202509084, 2025102210, 202504084, 202503196, 202504145, 202501094, 202408164, 202411124, 202503125, 202408094, 202505074, 202504224, 202411294, 202507144, 202408095, 202506304, 202511274, 202508184, 202503264, 202411115, 202504234, 202506264, 202501244, 202503034, 202509184, 202501236, 202411305, 202510304, 202505264, 202502055, 202412025, 202412195, 202410175, 202506054, 2025081811, 202503016, 202409034, 202409094, 202501134, 202507154, 202511284, 202506044, 202510094, 202411015, 202503145, 202408274, 202511264, 202411014, 202408155, 202509274, 202503156, 202508264, 202408194, 202504094, 202501234, 202408275, 202408154, 202408075, 202511194, 202504085, 202501245, 202412024, 202410115, 202412126, 202409025, 202409095, 202501235, 202410104. Manufactured from 14 June 2024 to 12 January 2026.
- Units affected
- 26,609 packs (159,657 eaches)
- Distribution pattern
- Nationwide distribution. International distribution to Australia, Austria, Belgium, Bosnia and Herzegovina, Canada, CHILE, CHINA, COLOMBIA, Croatia, Denmark, DOMINICAN REPUBLIC, ECUADOR, Egypt, Estonia, Finland, France, Germany, Greece, HONG KONG, India, INDONESIA, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, MALAYSIA, Malta, Montenegro, Netherlands, NEW ZEALAND, Norway, Oman, Palestine, PANAMA, PHILIPPINES, Poland, Qatar, Romania, Russia, Saudi Arabia, Serbia, SINGAPORE, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, TAIWAN,PROVINCE OF CHINA, THAILAND, Turkey, Ukraine, UNITED ARAB EMIRATES, United Kingdom. .
- Firm location
- Utica, NY, 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-2468-2026
- Recall initiated
- May 14, 2026
- FDA classification date
- June 17, 2026
- FDA report date
- June 24, 2026
- FDA event ID
- 98854
- Last updated on HTM Vibe
- July 23, 2026