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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

BD Pyxis MedFlex 2.0 and Bio-ID Spare Parts Recalled for Fire and Burn Risk

Agency Publication Date: February 21, 2025
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Summary

CareFusion 303, Inc. (BD) is recalling BD Pyxis MedFlex 2.0 Automated Dispensing Cabinets and Bio-ID spare parts because the fingerprint scanner can fail and overheat. The recall affects approximately 229 cabinets and 3,154 spare Bio-ID parts. While no injuries have been reported, the overheating scanners pose a risk of burns and potential fires within clinical settings. These cabinets are used by healthcare professionals to securely store and dispense medications and medical supplies.

Risk

The fingerprint scanner on these medical dispensing cabinets can fail, leading to significant overheating. This defect creates a risk of burn injuries to hospital staff and poses a fire hazard to the facility.

What You Should Do

  1. This recall involves BD Pyxis MedFlex 2.0 automated dispensing cabinets (Catalog Number 1139-00) and Bio-ID Spare Parts (Catalog Number 353200-01).
  2. Identify affected MedFlex 2.0 units by checking the catalog number and serial number located on the device label. See the Affected Products section below for the full list of affected codes.
  3. Identify affected Bio-ID Spare Parts by looking for Catalog Number 353200-01 and UDI-DI code 10885403450136 on the component packaging.
  4. Stop using the recalled product if you notice the fingerprint scanner is failing or becoming excessively hot to the touch.
  5. Contact CareFusion 303, Inc. or your authorized BD distributor to arrange for a return, replacement, or professional correction of the scanner unit.
  6. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

Your Remedy Options

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

Affected Products

Product: BD Pyxis MedFlex 2.0
Model / REF:
1139-00
Serial Numbers (229):
16188677
16234871
16234918
16234919
16234920
16235771
16235773
16235774
16235776
16235777
16235778
16235779
16235780
16237465
16237466
16237807
16237809
16237810
16237811
16237812
16237813
16238647
16245711
16245712
16245713
16245718
16248197
16248200
16248203
16248207
16248208
16248209
16248211
16248214
16248216
16248217
16249389
16249390
16249392
16249393
16249394
16249395
16253258
16253259
16253260
16253261
16253264
16253421
16253423
16255087
UDI:
10885403512704

Automated Dispensing Cabinet (ADC) for medications.

Product: Bio-ID Spare Parts
Model / REF:
353200-01
UDI:
10885403450136

Spare parts for automated dispensing cabinet fingerprint scanner.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96004
Status: Active
Manufacturer: CareFusion 303, Inc.
Sold By: CareFusion 303, Inc.; BD Authorized Channels
Manufactured In: United States
Units Affected: 229 MedFlex and 3,154 spare Bio-ID spare parts
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.