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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

Cypress Medical Products LLC: General Purpose Syringes Recalled for Lacking FDA Clearance

Agency Publication Date: September 16, 2024
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Summary

Cypress Medical Products LLC is recalling 3 boxes (totaling 75 units) of McKesson Brand 60 mL General Purpose Syringes because they were distributed without required FDA clearance. These syringes were intended to be held in quarantine but were accidentally shipped to customers due to an internal order processing error. Consumers should identify these products by the McKesson brand name and the 60 mL size on the packaging. Because these devices have not been reviewed by the FDA for safety and effectiveness, you should contact your healthcare provider or the manufacturer regarding their use and disposal.

Risk

These syringes lack FDA clearance, meaning the agency has not verified their safety, performance, or manufacturing quality for medical use. Using unvetted medical devices may lead to unpredictable performance or health risks during clinical procedures.

What You Should Do

  1. Locate any 60 mL McKesson Brand General Purpose Syringes in your inventory and check the packaging for Catalog Number 869662 and McKesson Brand Catalog Number 102-S60C.
  2. Verify the Unique Device Identifier (UDI-DI) number 20612479170302 printed on the product box to confirm if your supply is part of the recalled units.
  3. Immediately stop using the affected syringes and set them aside in a secure location to ensure they are not used on patients.
  4. Contact Cypress Medical Products LLC or your distributor to arrange for the return of the 3 boxes that were inadvertently shipped.
  5. Contact your healthcare provider if you have concerns about procedures where these specific syringes may have been used.
  6. For further questions or to report issues, contact the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Notification and Return

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety
Model / REF:
Catalog Number 869662
McKesson Brand Catalog Number: 102-S60C
Lot Numbers:
UDI-DI: 20612479170302

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95223
Status: Active
Manufacturer: Cypress Medical Products LLC
Sold By: Distribution Center
Manufactured In: United States
Units Affected: 3 Boxes (25 per box, 75 total units)
Distributed To: California, Nevada, New York

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.