Bolton Medical recalls

Bolton Medical has 5 recalls on record with the FDA and USDA, the earliest in 2023 and the latest reported on 3 Jun 2026. 4 are still ongoing. 1 was reported in the last 12 months.

Total recalls5since 2023

Last 12 months1reported

Class I120% of total

Ongoing4latest 3 Jun 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 1 0 0Aug 0 0

Severity split

Class I 1 20%Class II 4 80%Class III 0 0%

Why bolton medical is recalled

Other Reasons360%
Packaging Defects240%

Product types

Heart & Vascular Devices5100%

By year

2026120%
2024120%
2023360%

Ongoing bolton medical recalls

4 active

Reported	Class	Recall	Company	Reason	Where
3 Jun 2026Device	CLASS I	RelayPro Thoracic Stent-Graft System recalled by Bolton Medical	Bolton Medical	Other	PR
14 Jun 2023Device	CLASS II	The Treo Abdominal Stent-graft System recalled by Bolton Medical	Bolton Medical	Other	Nationwide
25 Jan 2023Device	CLASS II	Relay Pro, Thoracic Stent-graft System recalled by Bolton Medical	Bolton Medical	Packaging Defects	Nationwide
25 Jan 2023Device	CLASS II	Relay Pro, Thoracic Stent-graft System recalled by Bolton Medical	Bolton Medical	Packaging Defects	Nationwide

All bolton medical recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
3 Jun 2026Device	CLASS I	RelayPro Thoracic Stent-Graft System recalled by Bolton Medical	Bolton Medical	Other	PR
3 Apr 2024Device	CLASS II	Relay PRO Thoracic Stent-Graft System recalled by Bolton Medical	Bolton Medical	Other	Nationwide
14 Jun 2023Device	CLASS II	The Treo Abdominal Stent-graft System recalled by Bolton Medical	Bolton Medical	Other	Nationwide
25 Jan 2023Device	CLASS II	Relay Pro, Thoracic Stent-graft System recalled by Bolton Medical	Bolton Medical	Packaging Defects	Nationwide
25 Jan 2023Device	CLASS II	Relay Pro, Thoracic Stent-graft System recalled by Bolton Medical	Bolton Medical	Packaging Defects	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.