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The FDA identifies SunMed Holdings, LLC as the recalling firm in one or more MedWatcher-reviewed medical-device recall records.
This page includes only canonical device families and FDA recall events separately reviewed for publication by MedWatcher. It is not a complete product catalogue.
Canonical identity is based on the linked official product, UDI, or FDA recalling-firm source. Source-name variants are retained as aliases rather than separate manufacturer pages.
Source databases can use a legal name, brand, division, or shortened name. MedWatcher retains the form used as evidence rather than treating every similar name as the same manufacturer.
Page reviewed Aug 17, 2026 by MedWatcher project owner — FUS-265 · Next review by Nov 15, 2026.
Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life…