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Recall

Class I — Argon Medical Devices, Inc

Recalling firmARGON MEDICAL DEVICES, INC
Registered facilityView this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass I
StatusOngoing
ReasonKits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
ProductT-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL
Quantity850
DistributionDistribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
Initiated2026-06-01
Classified2026-07-10
Recall numberZ-2707-2026
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class I recall — Argon Medical Devices, Inc (Z-2707-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99069/

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