- Recalling firm
- Spectra Medical Devices, Llc
- Reason for recall
- Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clots, and organ failure.
- Affected products (lot / model / serial)
- Lot Code: Product codes: 1510-1 (individual ampule) / 1510-2 (carton) Lots: AB3005, AB3006, AB3007, AB3008, AB3009, AB3010, AB4001, AB4002, AB4003, AB4004, AB4005 AB4006, AB5001, AB5002, AB5003, AB5004, AB5005,AB5006, AB5007, AB5008 No individual UDI, as this product is used only within convenience kits.
- Units affected
- TBD
- Distribution pattern
- Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
- Firm location
- Wilmington, MA, United States
- Recall type
- Voluntary: Firm initiated
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2873-2026
- Recall initiated
- July 6, 2026
- FDA classification date
- August 11, 2026
- FDA report date
- August 19, 2026
- FDA event ID
- 98777
- Last updated on HTM Vibe
- August 26, 2026