FDA Medical devices recall ·
BD Pyxis MedFlex 2.0 recall
- Recall number
- Z-1207-2025
- Date
- (initiated January 23, 2025)
- Company / brand
- CareFusion 303, Inc.
10020 Pacific Mesa Blvd, San Diego, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 229 MedFlex and 3,154 spare Bio-ID spare parts
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
Due to fingerprint scanner failing resulting in the scanner heating up.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
BD Pyxis MedFlex 2.0 Catalog Number: 1139-00 UDI-DI code: 10885403512704 Serial/Lot Numbers: 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 16255088 16255089 16255090 16255091 16255092 16255093 16255094 16255648 16255649 16255650 16255651 16255652 16257751 16257779 16257780 16257782 16257783 16257784 16258336 16258339 16258341 16259235 16262553 16263864 16263866 16271070 16271697 16273523 16273525 16274621 16274623 16285712 16285719 16290130 16290131 16294039 16294040 16297183 16297187 16301869 16301974 16306024 16314884 16319674 16323805 16323807 16324856 16324858 16324880 16324881 16324882 16324883 16329840 16329841 16329842 16329843 16329844 16329845 16331234 16331235 16331237 16331239 16331241 16331243 16331371 16331372 16331373 16331374 16331376 16331473 16331474 16331475 16331476 16331477 16335406 16335407 16335408 16335925 16335926 16337394 16354646 16354647 16354648 16356143 16356144 16356145 16360888 16372466 16373119 16375388 16387858 16387868 16395522 16395523 16395524 16395525 16395527 16397522 16399720 16399721 16399723 16399725 16406085 16410148 16412199 16412200 164
Distribution
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.
States: Alabama 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 Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania South Carolina Tennessee Texas Virginia Vermont Washington Wisconsin Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1207-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.