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Needle

B& L Biotech, inc. · Model BSN2625 · UDI-DI 08800019101574

EKR
1
510(k) clearances
71
Adverse events
3
Recalls
143
Facilities

Recalls

DateFirmReason
2017-12-27Ormco/SybronendoBuchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU).
2013-01-17Ormco/SybronendoA recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Uni
2013-01-17Ormco/SybronendoA recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Uni

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.