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Ora-Aid
TBM Corporation · Model OB23 · UDI-DI 08800026800149
OLR
Prescription
1
510(k) clearances
10
Adverse events (3 deaths)
1
Recalls
30
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-02-21 | SA3, LLC | Due to failure of microbial testing for total aerobic microbial count (TAMC). |
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Get your free API keyRead the docsData 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.