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Covidien Lp Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT - safety alert

Official notice

19 Nov 2025

CriticalFDA

An official FDA notice concerns Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT. The notice reports a chemical exposure risk. Stop using the product and follow the official notice. Published 2025-11-19. Lots: N5F1971Y. Recall numbers: Z-0485-2026. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

3,263

Recall number

Z-0485-2026

Official notice

2025-11-19

The hazard

Chemical exposure risk

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

N5F1971Y

Event Ids

97792

Recall Numbers

Z-0485-2026

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Affected products

Product 1

Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT

Units affected

3,263

Risk / hazard

Chemical exposure risk

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States

Affected area 1

US · United States

Affected area 2

AT · Austria

Affected area 3

BE · Belgium

Affected area 4

CL · Chile

Affected area 5

DE · Germany

Affected area 6

EE · Estonia

Affected area 7

ES · Spain

Affected area 8

FI · Finland

Affected area 9

FR · France

Affected area 10

GB · United Kingdom

Affected area 11

GR · Greece

Affected area 12

HU · Hungary

Affected area 13

IL · Israel

Affected area 14

IT · Italy

Affected area 15

JP · Japan

Affected area 16

KW · Kuwait

Affected area 17

MY · Malaysia

Affected area 18

NL · Netherlands

Affected area 19

PL · Poland

Affected area 20

PT · Portugal

Affected area 21

RO · Romania

Affected area 22

SA · Saudi Arabia

Affected area 23

SK · Slovakia

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Covidien Lp. Contact: Covidien, LP.

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

critical

Recall details

Recall number

Z-0485-2026

Event id

97792

Units affected

3,263

Status

active

Classification

Class II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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