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RecallWatchMedical Device Safety
Class IIOngoingZ-1207-2025

CareFusion 303, Inc. recalls BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The BD Pyxis" M…

CareFusion 303, Inc.San Diego, CA, United StatesReported Mar 5, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

Due to fingerprint scanner failing resulting in the scanner heating up.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The BD Pyxis" MedFlex is an Automated Dispensing Cabinet (ADC) intended to securely store and dispense medications and supplies to a qualified and authorized user in a clinical setting
    UDI-DI codeCatalog # Number
    231 affected lots
    1618867716234871162349181623491916234920162357711623577316235774
    +223 more1623577616235777162357781623577916235780162374651623746616237807162378091623781016237811162378121623781316238647162457111624571216245713162457181624819716248200162482031624820716248208162482091624821116248214162482161624821716249389162493901624939216249393162493941624939516253258162532591625326016253261162532641625342116253423162550871625508816255089162550901625509116255092162550931625509416255648162556491625565016255651162556521625775116257779162577801625778216257783162577841625833616258339162583411625923516262553162638641626386616271070162716971627352316273525162746211627462316285712162857191629013016290131162940391629404016297183162971871630186916301974163060241631488416319674163238051632380716324856163248581632488016324881163248821632488316329840163298411632984216329843163298441632984516331234163312351633123716331239163312411633124316331371163313721633137316331374163313761633147316331474163314751633147616331477163354061633540716335408163359251633592616337394163546461635464716354648163561431635614416356145163608881637246616373119163753881638785816387868163955221639552316395524163955251639552716397522163997201639972116399723163997251640608516410148164121991641220016412201164122021641220316412204164134091641341316413414164134151641341616413417164134181641341916413420164134211641611216416513164165141641651516416516164165171641652116416522164165231641652416416525164231881642319116423192164231941642319516445044164450481644505216445058164463971645029116455056164551101646139616461398164614011646141116468079164680801646808116468082164681961646819716468198164681991646820016469897164743921647919116488020165036861652741916550170165748481659859016598591166011781660464516612167166121691662062216620623166206241662065416626427166264281664139116650692353200-0110885403450136

What the firm is doing

On 1/23/2025, the firm sent a "Urgent Medical Device Correction" Letter via FedEx and email to customers informing them that the firm became aware via customer complaints that an internal component within the Bio-ID (fingerprint scanner) is failing and resulting in the Bio-ID scanner heating up and could potentially cause superficial burns if finger is left on the scanner for up to or more than 5 seconds. Customers are instructed: 1. BD Pyxis" SupplyStation" and MedFlex 2.0 can continue to be used as intended. If you suspect that the Bio-ID Scanner is hot, please discontinue the use of the Bio-ID Scanner, submit a complaint to BD, and use your username and password to login instead. 2. Please return the customer response form to acknowledge receipt of this notice. For questions/assistance: -Technical Support - Phone: 1-866-930-9251 Phone hours: 24 hours, 7 days a week for Technical Questions. -Regional Complaint Center - Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaints when prompted. Mon-Fri 8:00am-5:00pm CT or Email: productcomplaints@bd.com for Product Complaints -Field action related questions - Email (pending) - Email for receipt of customer response forms and recall related questions.

DistributionShow details

Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI , IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, and WY. The countries of Australia, Bahrain, Belgium, Brazil, Canada, Hong Kong, Kuwait, Lebanon, New Zealand, Qatar, Saudi Arabia, Spain, and Thailand.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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