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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Healthmark Water Syringes and Convenience Packs Recalled for Contamination

Agency Publication Date: June 5, 2025
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Summary

Healthmark Industries Co., Inc. has recalled approximately 443,035 units of Pre-filled Water Syringes and ChannelCheck Convenience Packs due to potential contamination. During routine monitoring, contamination was discovered in equipment samples linked to these syringes, which Healthmark determined were being used improperly outside of their intended purpose. The recall involves specific models of syringes and diagnostic convenience packs manufactured in the United States.

Risk

The use of contaminated syringes during medical procedures or equipment monitoring could introduce pathogens, leading to patient infections or inaccurate diagnostic results. No specific patient injuries have been reported to date.

What You Should Do

  1. This recall affects Healthmark Pre-filled Water Syringes (Models SW-010-100 and SW-010) and ChannelCheck Convenience Packs (Models UCC-222CP and UCC-222-ESP).
  2. To identify if your products are affected, check the lot numbers printed on the product packaging or individual labels.
  3. Specific affected lot numbers include 200001 through 200013 for syringes, and various lots including 200014, 900153, and 103564 for convenience packs. See the Affected Products section below for the full list of affected codes.
  4. Stop using the recalled product immediately to prevent further risk of contamination.
  5. Contact Healthmark Industries or your product distributor to arrange for the return, replacement, or correction of the affected units.
  6. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information about this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Pre-filled Water Syringe
Model / REF:
SW-010-100
SW-010
Lot Numbers:
200001
200002
200003
200004
200005
200006
200007
200008
200009
200010
200011
200012
200013

Quantity: 250,000 units

Product: ChannelCheck Convenience Pack
Variants: Sample
Model / REF:
UCC-222CP
UCC-222-ESP
Lot Numbers:
200014
200015
200016
900153
900154
900155
900156
900157
900158
900159
900160
900161
900162
900163
900164
900165
900166
900167
900168
900169
900170
900171
900172
900173
900174
900175
900176
900177
103564
103312
103293
102807
102096
101673

Quantity: 193,035 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96823
Status: Active
Manufacturer: Healthmark Industries Co., Inc.
Sold By: Healthmark Industries Co., Inc.
Manufactured In: United States
Units Affected: 2 products (250000 units; 193035 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.