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ARISTA
Davol Inc. · Model AM0005 · UDI-DI 00801741044076
LMG
Prescription
0
510(k) clearances
1,764
Adverse events (27 deaths)
4
Recalls
27
Facilities
Description
Arista AH FlexiTip XL Applicator, 38 cm (15 in)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2024-06-11 | Ethicon Sarl, a Johnson & Johnson Company | Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging. |
| 2024-06-11 | Ethicon Sarl, a Johnson & Johnson Company | Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging. |
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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.