The Recall Desk

Manufacturer

Bolton Medical Inc.

5 recalls in our database name Bolton Medical Inc. as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
1
Most recent
2026-06-03

Of the 5 recalls from Bolton Medical Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (20%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–5 of 5

  • SevereFDA (Devices)·Z-2160-2026·2026-06-03

    RelayPro thoracic stent-graft clasp may not release from delivery system

    The RelayPro Thoracic Stent-Graft System is subject to a labeling update concerning proximal clasp disconnection from the outer control tube, which may prevent release of the graft.

    Product
    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-
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1383-2024·2024-04-03

    RELAY PRO Thoracic Stent-Graft System recalled for incorrect size

    Bolton Medical Inc. is recalling 21 RELAY PRO Thoracic Stent-Graft Systems because the stent-graft inside the delivery system is the incorrect size.

    Product
    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-M4-46-155-46U; (d) Part number 28-M4-32-155-32S; (e) Part
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1689-2023·2023-06-14

    TREO Abdominal Stent-Graft Label Does Not Match Actual Device Size

    Bolton Medical is recalling the TREO Abdominal Stent-Graft System because the carton label may not match the actual stent-graft size inside. Implanting the wrong size stent-graft could result in surgical complications.

    Product
    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-Graft. Each stent-graft is preloaded into its own delivery s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0998-2023·2023-01-25

    FDA Recalls Thoracic Stent-Graft Systems Over Manufacturing Size Defect

    Bolton Medical has recalled 640 units of RELAY PRO thoracic stent-graft systems worldwide because the products may be shorter than their packaging indicates.

    Product
    RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0997-2023·2023-01-25

    Thoracic Stent-Graft System Recalled Due to Dimensional Defect

    Bolton Medical's RELAY PRO thoracic stent-graft system is being recalled because affected units may be shorter than their packaging indicates. The recall affects 129 units distributed worldwide.

    Product
    RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Bolton Medical

Parent company
Terumo

Source: Wikidata (Q131551168), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.