Pre-filled Water Syringe recalled for improper use contamination
Healthmark Industries is recalling Pre-filled Water Syringes (Model SW-010-100 and SW-010) after duodenoscope contamination was linked to improper use of the syringes outside their intended purpose.
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 is an FDA Class II recall. The source text explicitly identifies the root cause as improper use outside intended purpose rather than a product defect, and there are no reports of patient illness or injury. The contamination was detected through surveillance monitoring, making this a precautionary recall related to user error rather than an inherent product hazard.
Plain-English summary
Healthmark Industries Co., Inc. is recalling Pre-filled Water Syringes, Model Numbers SW-010-100 and SW-010. During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to these syringes. Approximately 250,000 units have been distributed nationwide in the US and internationally to Canada and Malaysia.
The manufacturer conducted an investigation and determined that the Pre-filled Water Syringes had been improperly used outside of their intended purpose, which led to the contamination of duodenoscope samples. Healthcare facilities and users should verify they are using this product only as directed in its labeling and instructions for use to prevent similar contamination issues.
The recalled product
- Product
- Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
- Manufacturer
- Healthmark Industries Co., Inc.
- Affected units
- 250,000
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Healthmark Industries Co., 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 2 products in this recall →Related recalls
Same manufacturer · Healthmark Industries Co., Inc.
See all →- ModerateHealthmark Vinyl Instrument Guards Recalled for Labeling Non-Compliance
FDA (Devices) · 2026-10-21
- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHealthmark ProChek-II Medical Tests Recalled for Expired Ingredient
FDA (Devices) · 2026-09-02
- HighMesh Style Tip Protectors recalled lacking FDA clearance
FDA (Devices) · 2026-05-06
- HighChannelCheck Convenience Pack Pre-filled Water Syringes Recalled
FDA (Devices) · 2025-06-11
Same hazard · contamination
See all →- SevereEthicon Recalls Silk Surgical Sutures Packaged with Alcohol-Based Fluid
FDA (Devices) · 2026-10-21
- ModerateBioFire FilmArray Pneumonia Panel Plus Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateBioFire Joint Infection Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateBioFire FilmArray Pneumonia Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- SevereSterile Water Syringes recalled for lack of sterility assurance
FDA (Devices) · 2023-12-27
- SeverePremier Pharmacy Labs Recalls Hydromorphone Syringes Due to Sterility Concerns
FDA (Drugs) · 2018-05-02
- HighSwabFlush prefilled syringes carry SwabCaps with a compromised seal
FDA (Devices) · 2025-08-06
- SevereMedical Device Surgical Kits with Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- HighMedline Medical Convenience Kits with Plastic Syringes Recalled Due to Leaks and Breakage
FDA (Devices) · 2024-09-18
- HighMedline Syringes Recalled Due to Leaks, Breakage, and Quality Issues
FDA (Devices) · 2024-06-12