BOLTON MEDICAL, INC.
4 recall(s) on record — most severe on record: Class I.
Recalls by year
- Recalls (4)
Registered facilities (1)
- BOLTON MEDICAL, INC. FEI 1000135961 · FL
Recalls & enforcement
- Class IOngoing2026-04-22Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
- Class IICompleted2024-02-22The stent-graft inside the delivery system was the incorrect size.
- Class IIOngoing2023-05-03Potential for the incorrect size stent-graft than the printed carton label.
- Class IIOngoing2022-12-20The product may be shorter than packaging indicates
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “BOLTON MEDICAL, INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9007572-bolton-medical-inc/
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