RegWardenFDA facility compliance records
Recall

Class II — MAST Biosurgery USA, Inc

Recalling firmMast Biosurgery USA
Registered facilityMAST BIOSURGERY USA INC. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonThe expiration date of the bar code on the envelope label did not match the expiration date next to the hourglass. The printed expiration date was August of 2017, while the bar code date read as July 31, 2017. The correct expiration date was July 31, 2017.
ProductThe SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm (01) 18964050255027 (17) 170731(10)52804 LOT 52804 2017-08 REF25502-01 Product is wrapped in a foil pouch that is then sealed into an additional envelope.
Quantity49 pieces
DistributionWorldwide Distribution to the country of China.
Initiated2014-08-26
Classified2015-02-10
Terminated2015-02-24
Recall numberZ-1076-2015
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 — MAST Biosurgery USA, Inc (Z-1076-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70051/

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