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Recall

Class II — Microline Surgical, Inc.

Recalling firmMICROLINE SURGICAL, INC.
Registered facilityMicroline Surgical, Inc (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonA lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off.
ProductMicroscissor Tip (Disposable); Microline Catalog #: 3122.
Quantity200 units
DistributionWorldwide - US Nationwide in the state of OK and the country of Japan.
Initiated2024-11-05
Classified2024-12-10
Recall numberZ-0663-2025
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 II recall — Microline Surgical, Inc. (Z-0663-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95734/

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