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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/Surgical Equipment

B Braun Medical Inc: Stimuplex A Needles Recalled Due to Mislabeling Regarding DEHP Content

Agency Publication Date: June 11, 2024
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Summary

B Braun Medical Inc. is recalling approximately 3,071,292 Stimuplex A needles because the devices are labeled as "not made with DEHP" or featuring the DEHP-free symbol, when the glue used in the product actually contains traces of DEHP. This recall affects various needle sizes and lengths, including 24G, 21G, 20G, and 22G models. No specific injuries or incidents have been reported in the provided data. Consumers and medical professionals should contact their healthcare provider or the manufacturer for further instructions regarding these needles.

Risk

Patients may be inadvertently exposed to traces of the chemical DEHP (a plasticizer) despite the product's DEHP-free labeling, which could be a concern for sensitive populations or those specifically requiring DEHP-free medical equipment.

What You Should Do

  1. Identify if you have the affected Stimuplex A needles by checking the Catalogue Number and Lot/Batch codes on the product packaging.
  2. For Stimuplex A 30 DEG 24GX1", check for Catalogue Number 4894251 and lot codes 20E15, 19L09, 19L27, 20A19, 20H21, 21G14, 21I16, or 22H23.
  3. For Stimuplex A 30 DEG 21GX4", check for Catalogue Number 4894260 and over 200 specific lot codes including 22E07, 20E08, 23K11, and others listed in the product details.
  4. For Stimuplex A 30 DEG 20GX6", check for Catalogue Number 4894278 and lot codes such as 20E15, 21E18, 19F08, 23I29, and others in that series.
  5. For Stimuplex A 30 DEG 22GX2", check for Catalogue Number 4894502 and lot codes such as 20E01, 20E03, 21E07, 23K18, 23K19, and others in that series.
  6. If you have an affected product, contact B Braun Medical Inc at 200 Boulder Dr, Breinigsville, Pennsylvania, or your healthcare provider to discuss the impact of this labeling error.
  7. Healthcare facilities should follow internal protocols for handling recalled medical devices and contact the manufacturer for further guidance.
  8. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Consultation and Information

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

Affected Products

Product: Stimuplex A, 30 DEG, 24GX1", 0.55x25mm
Model / REF:
4894251
UPC Codes:
04022495101167
Lot Numbers:
20E15
19L09
19L27
20A19
20H21
21G14
21I16
22H23
Product: Stimuplex A, 30 DEG, 21GX4", 0.80x100mm
Model / REF:
4894260
UPC Codes:
04022495101211
Lot Numbers (277):
22E07
20E08
20E09
23E09
23E10
19E11
23E11
23E13
19E14
20E14
19E15
19E16
23E17
23E18
23E20
22E21
21E25
22E25
22E27
20E29
19E30
20E30
19E31
22E31
19F04
19F05
19F07
19F21
19F22
19F26
19F27
19F28
19F29
19G30
19H01
19H02
19H07
19H08
19H31
19I04
19I06
19I07
19K01
19K02
19K04
19K08
19K09
19K27
19K30
19L06
Product: Stimuplex A, 30 DEG, 20GX6", 0.90x150mm
Model / REF:
4894278
UPC Codes:
04022495101266
Lot Numbers:
20E15
21E18
19F08
19G10
19G13
19G19
19I19
20C28
20C31
20D10
20L19
21B13
21I17
21K21
21L12
21M16
22D12
22H20
22I22
22K27
23A20
23C04
23D14
23F09
23I08
23I29
Product: Stimuplex A, 30 DEG, 22GX2", 0.70x50mm
Model / REF:
4894502
UPC Codes:
04022495101310
Lot Numbers (207):
20E01
20E03
21E07
21E09
19E10
22E10
22E11
21E13
20E19
20E20
19E21
19E22
20E22
23E26
20E27
23E31
19F12
19F13
19F15
19G03
19G04
19G06
19G09
19G20
19G21
19G24
19G25
19G27
19H23
19H28
19H30
19I11
19I21
19I25
19I26
19K11
19K16
19K17
19K24
19K25
19L12
19L13
19L15
19L19
19M12
19M14
19M17
19M21
19M24
19M26

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94637
Status: Active
Manufacturer: B Braun Medical Inc
Sold By: authorized medical distributors; healthcare facilities
Manufactured In: United States
Units Affected: 4 products (20,850 units; 1,783,991 units; 108,811 units; 1,157,640 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.