Facility

BOLTON MEDICAL, INC.

4 recall(s) on record — most severe on record: Class I.

Key facts

4recalls · worst Class I

3inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1000135961
Establishment type	Manufacture Medical Device
Location	799 International Pkwy Sunrise, FL, US 33325
Registration status	Active · expires 2026
Parent company	BOLTON MEDICAL, INC. (owner-operator 9007572)
Brand names	Relay Thoracic Stent-Graft with Plus Delivery System

Activity by year

Recalls (4)
Inspections (3)

Devices registered here (1)

System, Endovascular Graft, Aortic Aneurysm Treatment
Product code MIH (opens in a new tab) · Class III · Unknown

Recalls & enforcement

Class IOngoing2026-04-22
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
Class IICompleted2024-02-22
The stent-graft inside the delivery system was the incorrect size.
Class IIOngoing2023-05-03
Potential for the incorrect size stent-graft than the printed carton label.
Class IIOngoing2022-12-20
The product may be shorter than packaging indicates

FDA inspections (3)

NAI2019-11-20
No Action Indicated · Bioresearch Monitoring
NAI2019-09-16
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2016-09-12
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by BOLTON MEDICAL, INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “BOLTON MEDICAL, INC. (FEI 1000135961) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000135961-bolton-medical-inc/

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