FDA Closes AVID Medical Recall of Halyard Total Joint Kits Over Missing Latex Labeling
The FDA has terminated the Class II recall of 78 Halyard TOTAL JOINT kits distributed in Mississippi and Texas, saying the labeling failed to identify natural rubber latex in a component.
2 reports on this incident · first at Sep 9, 2026, 9:13 p.m. ET
Earlier reports
Sep 9, 2026, 9:13 p.m. ETFirst report
AVID Medical Recalls Halyard Total Joint Kits Over Missing Latex Labeling
AVID Medical, Inc., of Toano, Virginia, is recalling 78 Halyard TOTAL JOINT kits, model/catalog number MSBM036-03, according to the FDA enforcement report for recall number Z-3011-2026. The report, dated September 2, 2026, states the reason as a labeling deficiency: the medical kit labeling fails to identify that the statlock component contains natural rubber latex.
The recall is classified as Class II, the FDA's middle category, used where the product may cause temporary or medically reversible harm and where the chance of serious harm is remote, according to the agency's recall definitions. The FDA enforcement report lists the recall as ongoing. The kits were distributed nationwide in the states of Mississippi and Texas, the report states.
The affected kits carry lot number 1649519 and UDI 10809160457887, according to the enforcement report. The recall was initiated on July 9, 2026, and the report date is September 2, 2026.
The Halyard TOTAL JOINT kit is a pre-packaged surgical convenience kit composed of synthetic fabrics, plastic attachments, securing components, and natural rubber latex, used for setting up operating room materials during total joint surgical procedures, according to FDA and Halyard Health product information. It is normally sold as a pre-assembled kit through medical equipment distributors to institutional healthcare facilities.
The FDA's recall database records no other enforcement action by this firm.
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- Version 110 Sept 2026, 01:13current
First published.
- Version 110 Sept 2026, 01:24current
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