Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1492-2022·Announced 2022-08-10

EkoSonic Endovascular Device Kit Mislabeled: Boston Scientific Recall

Boston Scientific is recalling 10 units of the EkoSonic Kit endovascular device due to product mislabeling. Affected devices were distributed to medical facilities in 10 US states.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This FDA Class II device recall involves a labeling error without reported adverse events or injuries. The limited distribution (10 units across 10 states) and absence of clinical harm place this in the moderate-severity category per the rubric criterion for minor labeling errors.

Plain-English summary

Boston Scientific Corporation is recalling 10 units of the EkoSonic Kit (106cm, 12cm TZ) endovascular device because the product may be mislabeled. The affected devices were distributed to medical facilities in California, Connecticut, Georgia, Iowa, Illinois, Indiana, New York, Ohio, Texas, and Wyoming.

The affected lot numbers are: 8035075225, 8035075226, 8035075227, 8035075228, 8035075229, 8035075230, 8035075231, 8035075232, 8035075233, and 8035075234 (UPN: 500-55112; GTIN: 858593006134).

Healthcare facilities that received devices with these lot numbers should stop use and contact Boston Scientific Corporation for instructions on product return or replacement. No adverse events or injuries have been reported.

The recalled product

Product: EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product…
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Endovascular
Hazard: mis-labeling
Affected units: 10

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

UPN: 500-55112 GTIN: 858593006134 Lot Numbers: 8035075225
8035075226
8035075227
8035075228
8035075229
8035075230 8035075231
8035075232
8035075233
8035075234

Distribution

Distributed in 10 states:

Part of a larger recall action

This product is one of 2 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Boston Scientific Corporation

See all →

Moderate
Boston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
Severe
Boston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
Moderate
Boston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
High
Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
High
Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09

Same hazard · mis labeling