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Healthmark Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010 - safety alert

Official notice

11 Jun 2025

MediumFDA

An official FDA notice concerns Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010. The notice reports a contamination risk. Do not use the product and return it as directed. Published 2025-06-11. Lots: 200001. Recall numbers: Z-1909-2025. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

250,000

Recall number

Z-1909-2025

Official notice

2025-06-11

The hazard

Contamination 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

200001

Event Ids

96823

Recall Numbers

Z-1909-2025

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Affected products

Product 1

Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010

Units affected

250,000

Risk / hazard

Contamination 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

CA · Canada

Affected area 3

MY · Malaysia

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Healthmark. Contact: Healthmark Industries Co., Inc..

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-1909-2025

Event id

96823

Units affected

250,000

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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