Sunrise, FL, United States
Bolton Medical Inc. recalls
4 recalls recorded since 2018, most recently on 22 April 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)3
Terminated or completed1
Class I (FDA)1
Ongoing Class I Medical devices
- Recall started
- 22 April 2026
- Reason
- Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
- Distribution
- Worldwide - distribution in the US Territory of Puerto Rico and the countries of Argentina, Chile, Canada, Colombia, Mexico, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2160-2026
- 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-N4-34-15
Completed Class II Medical devices
- Recall started
- 22 February 2024
- Reason
- The stent-graft inside the delivery system was the incorrect size.
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, MA, and TX. The countries of Chile, France, Germany, Italy, Japan, Poland, Spain, and Thailand.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1383-2024
- RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part number 28-M4-34-100-34U; (b) Part number 28-M4-30-095-30U; (c) Part number 28-
Ongoing Class II Medical devices
- Recall started
- 3 May 2023
- Reason
- Potential for the incorrect size stent-graft than the printed carton label.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of FL, NY, VA, WA and the countries of Italy, Great Britain, and Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1689-2023
- The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graft and a Straight Iliac Extension Stent-
Ongoing Class II Medical devices
- Recall started
- 20 December 2022
- Reason
- The product may be shorter than packaging indicates
- Distribution
- Worldwide distribution - US Nationwide and the countries of UK, France, Germany, Italy, Netherlands, Chile, Japan, and China.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0997-2023, Z-0998-2023
- RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX
- RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.