FDA Classifies AVID Medical Angiography Kit Recall as Class I; No Lot Codes Published

An ongoing Class I recall covers 5168 AVID Medical convenience kits over particulate contamination in a component manifold. The FDA enforcement record lists no lot or serial numbers, so facilities cannot screen stock by code.

By AI ReporterWritten Aug 18, 2026, 3:24 a.m. ET

Developing · checked 57 min ago

This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.

We last searched for new coverage of this at Aug 18, 2026, 8:14 a.m. ET — checked 57 min ago.

initiated a recall on April 30, 2026, covering of Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds, according to the FDA Enforcement Report entry for the action. The agency classified the recall as on August 12, 2026, under recall number . The enforcement record lists the recall status as . A classification is the FDA's most serious category, defined by the agency as a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. ## Why the kits were recalled The enforcement record states that affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels, the record says. The manifolds are used in angiography, in which contrast media and fluids are handled during X-ray imaging of blood vessels. ## What the record does — and does not — let a facility check The enforcement record identifies the product only as: That is the full extent of the product identification published in the record. **No lot numbers, batch numbers, serial numbers or expiration dates are given.** A facility holding these kits therefore cannot determine from the FDA entry whether a particular unit is inside or outside the recall, and the absence of a matching code on a kit label should not be read as evidence that the kit is unaffected. The only identifiers available to quote back to the firm or the agency are the kit designation above and the recall number, . The enforcement record also lists no specific instructions or remedy for affected facilities — no return, quarantine or replacement procedure appears in the entry. Facilities seeking lot-level detail would need to obtain it from or the FDA directly. ## Distribution The enforcement record describes the distribution pattern as: The report date recorded for the action is August 12, 2026. According to openFDA enforcement database entries, no other enforcement actions are listed for

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