Quick Facts at a Glance
- Recall Date
- April 22, 2026
- Hazard Level
- HIGH
- Brand
- Bolton Medical
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Bolton Medical
- Model numbers
- All Lots/(Ref Number/Proximal Diameter/DI)28-N4-32-104-32U/ 32/ (01)00843576150461, 28-N4-32-164-28U/ 32/ (01)00843576150959, 28-N4-32-164-32U/ 32/ (01)00843576150591, 28-N4-32-209-28U/ 32/ (01)00843576151055, 28-N4-32-209-32U/ 32/ (01)00843576150720, 28-N4-32-259-32U/ 32/ (01)00843576150850, 28-N4-34-109-34U/ 34/ (01)00843576150478, 28-N4-34-154-30U/ 34/ (01)00843576150966 +12 more
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
April 22, 2026
Reported by FDA DEVICE
June 3, 2026
RecallRadar source check
June 10, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Bolton Medical Inc. or your healthcare provider for instructions
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Full Description
RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-34-109-34U 28-N4-34-154-30U 28-N4-34-154-34U 28-N4-34-209-30U 28-N4-34-209-34U 28-N4-34-259-34U 28-N4-36-109-36U 28-N4-36-154-32U 28-N4-36-154-36U 28-N4-36-199-32U 28-N4-36-199-36U 28-N4-36-259-36U 28-N4-38-109-38U 28-N4-38-154-34U 28-N4-38-154-38U 28-N4-38-199-34U 28-N4-38-199-38U 28-N4-38-259-38U 28-N4-40-114-40U 28-N4-40-154-36U 28-N4-40-154-40U 28-N4-40-204-36U 28-N4-40-204-40U 28-N4-40-259-40U 28-N4-42-114-42U 28-N4-42-159-38U 28-N4-42-159-42U 28-N4-42-204-38U 28-N4-42-204-42U 28-N4-42-259-42U 28-N4-44-114-44U 28-N4-44-164-40U 28-N4-44-164-44U 28-N4-44-209-40U 28-N4-44-209-44U 28-N4-44-259-40U 28-N4-44-259-44U 28-N4-46-114-46U 28-N4-46-164-42U 28-N4-46-164-46U 28-N4-46-209-42U 28-N4-46-209-46U 28-N4-46-259-42U. Reason: Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.. Classification: Class I. Distribution: Worldwide - distribution in the US Territory of Puerto Rico and the countries of Argentina, Chile, Canada, Colombia, Mexico, United Kingdom.
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