- Recalling firm
- Medline Industries, LP
- Reason for recall
- Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
- Affected products (lot / model / serial)
- Lot EP250203 Item no. 401206RH - UDI-DI 10197344043767; Item no. 401305RH - UDI-DI 10197344043637.
- Units affected
- 3
- Distribution pattern
- US Nationwide distribution in the state of TX.
- 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-2615-2026
- Recall initiated
- May 15, 2026
- FDA classification date
- July 2, 2026
- FDA report date
- July 8, 2026
- FDA event ID
- 99122
- Last updated on HTM Vibe
- July 23, 2026