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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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Critical RiskFDA Device
Medical Devices

Fresenius Medical Care Holdings, Inc.: Medical Syringes Recalled for Blood Backfill Leakage and Foreign Material

Agency Publication Date: October 6, 2023
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Summary

Fresenius Medical Care is recalling approximately 374,319 Luer Lock syringes across three different models due to potential defects that may allow blood to leak back through the device or the presence of foreign material. These syringes include the 10mL Luer Lock (with and without needles) and the 3mL Luer Lock with a 20GX1 needle. These medical devices were distributed nationwide and are being recalled because the reported defects could compromise the sterile field or lead to contamination during medical procedures. Consumers and healthcare providers should identify these products by their specific part numbers and UDI-DI codes.

Risk

The syringes may suffer from blood backfill leakage or contain foreign material, which can lead to infection, exposure to bloodborne pathogens for healthcare workers, or the introduction of contaminants into a patient's bloodstream.

What You Should Do

  1. Identify your syringes by checking the packaging for Part Numbers 15-R010-0 (10mL without needle), 15-10ML-0 (10mL with needle), or 15-03ML-0 (3mL with 20GX1 needle).
  2. Verify the UDI-DI codes on the box or case: 16945060501122, 16945060500125, or 16945060500101. All lot numbers for these products are affected.
  3. Stop using these syringes immediately and set them aside in a secure location to prevent accidental use.
  4. Contact your healthcare provider if you have used these syringes and have concerns about potential contamination or exposure.
  5. Contact Fresenius Medical Care Holdings, Inc. at their Waltham, Massachusetts headquarters for specific instructions regarding the return of the product or potential refunds.
  6. Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

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

Affected Products

Product: 10ML SYRINGE LUER LOCK W/OUT NEEDLE (100 per box, 12 boxes per case)
Model / REF:
15-R010-0
Recall #: Z-0005-2024
UPC Codes:
16945060501122
Lot Numbers:
All Lots
Product: 10ML SYRINGE LUER LOCK W/NEEDLE (100 per box, 12 boxes per case)
Model / REF:
15-10ML-0
Recall #: Z-0006-2024
UPC Codes:
16945060500125
Lot Numbers:
All Lots
Product: 3ML Syringe Luer Lock with needle 20GX1 (100 per box, 24 boxes per case)
Model / REF:
15-03ML-0
Recall #: Z-0007-2024
UPC Codes:
16945060500101
Lot Numbers:
All Lots

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92906
Status: Active
Manufacturer: Fresenius Medical Care Holdings, Inc.
Sold By: Fresenius Medical Care Holdings, Inc.
Manufactured In: United States
Units Affected: 3 products (124,773 boxes total)
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.