Agency classClass IIOur severity:High FDA (Devices)·Z-1529-2013·Announced 2013-06-19

Bard Usher Support Catheters Recalled for Incomplete Sterilization

Bard Peripheral Vascular is recalling 223 Usher Support Catheters that were distributed without completing the sterilization process.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device distributed without sterilization, creating a risk of infection or harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Bard Peripheral Vascular (BPV) is recalling 223 units of the Usher Support Catheter (Angled Tip, WL130cm, RI 7F; REF USH07AT; Lot# FCWC10009). The recall was initiated because a combination of Bard UltraClip Dual Trigger Tissue Markers and support catheters, including the Usher model, were inadvertently distributed to customers without completing the sterilization process. As a result, the affected devices are non-sterile.

The affected products were distributed nationwide to customers in Alabama, Arkansas, Arizona, California, Colorado, Connecticut, the District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington, West Virginia, and Wyoming. The devices are manufactured by FlowCardia, Inc., a subsidiary of C. R. Bard, Inc.

Healthcare providers and facilities should stop using the affected Usher Support Catheters immediately. Patients who have received these devices should contact their healthcare provider for further instructions.

The recalled product

Product: USHER¿ Support Catheter- Angled Tip WL130cm, RI 7F; REF USH07AT; PK1022-01A; Rx only, Non-Pyrogenic, Sterile; Bard Peripheral Vascular; Manuf: FlowCardia, Inc., a Subsidiary of C. R. Bard, Inc., 745 North Pastoria Ave, Sunnyvale CA 95085. The Usher¿ Peripheral is a single…
Manufacturer: Bard Peripheral Vascular Inc
Category: Medical Device — Catheter
Hazard: infection
non-sterile
Affected units: 223

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 (2)

PC USH07AT
Lot# FCWC10009

Distribution

Distributed nationwide across the United States.

The notice also names 33 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Bard Peripheral Vascular Inc 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 4 products in this recall →

Same manufacturer · Bard Peripheral Vascular Inc

See all →

High
Bard EnCor EnCompass Breast Biopsy System Software Recall
FDA (Devices) · 2026-10-07
High
Catheter cutdown trays recalled over damage to the outer tray
FDA (Devices) · 2026-02-25
High
Drainage catheter trays recalled over safety indicators showing the wrong position
FDA (Devices) · 2025-12-17
Moderate
Vein ablation generators recalled over software falsely flagging working catheters
FDA (Devices) · 2025-10-08
Critical
Rotarex Atherectomy Catheter Recalled for Helix Fracture Risk
FDA (Devices) · 2025-03-12

Same hazard · infection