Z-1909-2025Class II

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

Name: Z-1909-2025 Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
Creator: Healthmark Industries Co., Inc.
Published: 2025-05-02
License: https://open.fda.gov/license/

Healthmark Industries Co., Inc. / initiated 2025-05-02 / Open, Classified

FDA source

Healthmark Industries Co., Inc. began a recall of Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010 on 2025-05-02. FDA classified it as Class II and gives the reason as "During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation. Healthmark Industries...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1909-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-02
Posted: 2025-06-05
Recalling firm: Healthmark Industries Co., Inc.
Product: Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
Product code: MNL Accessories, Cleaning Brushes, For Endoscope
Reason for recall: During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation. Healthmark Industries conducted its own investigation and concluded that the Pre-filled Water Syringe had been improperly used outside of the intended purpose.
FDA root cause: Under Investigation by firm
Action: An "URGENT PRODUCT RECALL" notification letter was sent to customers beginning 5/2/25. Recommended Mitigations/ User Recommendations Please discontinue use of the Pre-Filled Water Syringes containing non-sterile water, which can be identified by a red cap. Any unused product can be returned for credit or replacement. Customer are requested to take the following actions 1. Ensure all affected product in your facility s inventory is no longer in use and has been properly quarantined. 2. Please ensure this message is forwarded to any individuals that need notification within your organization or any organization where the affected products have been transferred. 3. Contact Customer Service via email at [email protected] or 800-521-6224 to return your unused affected product or if you have any questions. 4. Complete and return the response form Getinge by e-mailing a copy to [email protected].
Quantity in commerce: 250000 units
Distribution: US Nationwide and Internationally to countries of: Canada, Malaysia.
Product codes and lots: Lot Numbers: 200001 200002 200003 200004 200005 200006 200007 200008 200009 200010 200011 200012 200013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1909-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1909-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-11	2025-06-05
Z-1910-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-11	2025-06-05

Product code MNL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)