FDAJanuary 2, 2025device
Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP125253PK AP125313PK AP135213PK AP135253PK AP135313PK AP145213PK AP145253PK AP145313PK AP1GP213PK AP1GP253PK AP1GP313PK O.U.S. Products: EdgeFile X7 REF: SX70421MM SX70425MM SX70429MM SX7062...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to devices being irradiated above the established specification which my result in package integrity issues.
What to do
FDA enforcement status: Ongoing
Brands named
us endodontics
UPCs
008879198113430088791981137400887919811404008879198114350088791981146600887919811497008879198115270088791981155800887919811589008879198116190088791981164000887919811671
Recall history
No related federal recalls on record for this brand yet.
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