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Recall

Class II — MicroAire Surgical Instruments, LLC

Recalling firmMICROAIRE SURGICAL INSTRUMENTS, LLC
Registered facilityMICROAIRE SURGICAL INSTRUMENTS LLC (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonComplaints that the cannula bent/broke during surgery.
ProductMicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula
Quantity37
DistributionWorldwide Distribution. US nationwide including Puerto Rico, Australia, Bangladesh, Czech Republic, India, Japan, Lebanon, New Zealand, Norway, Singapore, Switzerland, Taiwan, and Turkey.
Initiated2016-02-08
Classified2016-04-05
Terminated2016-08-12
Recall numberZ-1323-2016
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 — MicroAire Surgical Instruments, LLC (Z-1323-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73259/

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