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Medium RiskFDA Device
Medical Devices/Home Healthcare

Becton Dickinson & Company: BD Infusion and Gravity Sets Recalled for Containing Restricted DEHP

Agency Publication Date: November 17, 2023
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Summary

Becton Dickinson & Company (BD) has recalled several types of Alaris and gravity infusion sets because they were incorrectly labeled as being 'DEHP-free' when they actually contain di(2-ethylhexyl) phthalate (DEHP). DEHP is a chemical plasticizer that can leach out of medical tubing and into the fluids being delivered to patients. The recall affects a wide range of pump sets, gravity sets, and extension sets with expiration dates ranging from July 2026 to October 2026.

Risk

DEHP exposure through medical devices can pose health risks, particularly to sensitive populations like infants and pregnant women, as it may interfere with hormone systems and development. Because these products were marketed as DEHP-free, healthcare providers may have inadvertently used them for patients specifically requiring non-DEHP equipment.

What You Should Do

  1. Check the catalog numbers and UDI-DI identifiers on your infusion set packaging to determine if you have affected units. Affected Alaris Pump sets include catalog numbers 10010483, 10010453, 10010454, 10013072, 10013361, 10013890, 10015012, 10015862, 10062818, 10821753, 11171447, 11426964, 11532269, 11613191, 10015861A, 22000-B007T, 2202-0007, 2204-0007, 2206-0007, 2260-0500, 22600-0007T, 22601-B007T, 22602-B007T, 22603-B007T, 24001-0007, 2403-0007, 24301-0007T, 2441-0007, 2450-0500, 24600-0007, 24601-B007T, 2465-0007, and 2466-0007.
  2. Check for affected Gravity and Extension sets under catalog numbers 4030B-07T, 42081E, 10013902, 20062E, 70000N-07, ME1224, 20350ET, and 70001B-07T.
  3. Immediately stop using these sets for patients where DEHP-free tubing is clinically required, such as neonates, infants, or pregnant women.
  4. Contact your healthcare provider or Becton Dickinson & Company for further instructions regarding product returns and potential refunds.
  5. 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

Healthcare provider or manufacturer consultation

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

Affected Products

Product: BD Alaris Pump Infusion Sets
Model / REF:
10010483
10010453
10010454
10013072
10013361
10013890
10015012
10015862
10062818
10821753
11171447
11426964
11532269
11613191
10015861A
22000-B007T
2202-0007
2204-0007
2206-0007
2260-0500
22600-0007T
22601-B007T
22602-B007T
22603-B007T
24001-0007
2403-0007
24301-0007T
2441-0007
2450-0500
24600-0007
24601-B007T
2465-0007
2466-0007
Lot Numbers:
All lots
Date Ranges: expiration date thru July 31, 2026
Product: BD Gravity Sets
Model / REF:
4030B-07T
42081E
Lot Numbers:
All lots
Date Ranges: expiration date thru July 31, 2026
Product: BD Extension Sets
Model / REF:
10013902
20062E
70000N-07
ME1224
20350ET
70001B-07T
Lot Numbers:
All lots
Date Ranges: expiration date thru October 16, 2026

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93266
Status: Active
Manufacturer: Becton Dickinson & Company
Sold By: Hospitals; Medical Supply Distributors
Manufactured In: United States
Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, Wyoming

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.

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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.