--- title: "Bolton Medical Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Bolton Medical Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/bolton-medical-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Bolton Medical Inc. recall records **4** reported ongoing 5 records in this archive. Latest source date Apr 22, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Apr 22, 2026 FDA device enforcement ### [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-...](https://isitonrecall.com/recall/fda-device-z-2160-2026-relaypro-thoracic-stent-graft-system-various-sizes-reference-numbers-28-n4-32-104-32u-28-n4-32-164-2/) Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system. Class I Reported ongoing Distribution: Worldwide - distribution in the US Territory of Puerto Rico and the countries of Argentina, Chile, Canada, Colombia, Mexico, United Kingdom. [Official source for RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2160-2026%22) Feb 22, 2024 FDA device enforcement ### [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...](https://isitonrecall.com/recall/fda-device-z-1383-2024-relay-pro-thoracic-stent-graft-system-containing-one-endovascular-stent-graft-system-ifu-and-patient/) The stent-graft inside the delivery system was the incorrect size. Class II Reported completed 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. [Official source for RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and p...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1383-2024%22) May 3, 2023 FDA device enforcement ### [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-G...](https://isitonrecall.com/recall/fda-device-z-1689-2023-the-treo-abdominal-stent-graft-system-treo-consists-of-four-types-of-implants-specifically-a-main-bi/) Potential for the incorrect size stent-graft than the printed carton label. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, NY, VA, WA and the countries of Italy, Great Britain, and Switzerland. [Official source for The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a M...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1689-2023%22) Dec 20, 2022 FDA device enforcement ### [RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX](https://isitonrecall.com/recall/fda-device-z-0997-2023-relay-pro-thoracic-stent-graft-system-ref-28-m4-xx-xxx-xxx/) The product may be shorter than packaging indicates Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of UK, France, Germany, Italy, Netherlands, Chile, Japan, and China. [Official source for RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0997-2023%22) Dec 20, 2022 FDA device enforcement ### [RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX](https://isitonrecall.com/recall/fda-device-z-0998-2023-relay-pro-thoracic-stent-graft-system-ref-28-n4-xx-xxx-xxx/) The product may be shorter than packaging indicates Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of UK, France, Germany, Italy, Netherlands, Chile, Japan, and China. [Official source for RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0998-2023%22) ## Reasons in these listed records - Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system. - The stent-graft inside the delivery system was the incorrect size. - Potential for the incorrect size stent-graft than the printed carton label. - The product may be shorter than packaging indicates These examples come from this result page and are not a ranking of every recall reason. ## Checking Bolton Medical Inc. ### Is there a recall on bolton medical inc. right now? This archive contains 5 records, including 4 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Bolton Medical Inc.](https://isitonrecall.com/check/?q=Bolton%20Medical%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)