BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The BD Pyxis" MedFlex is ...
FDA Device Recall #Z-1207-2025 — Class II — January 23, 2025
Recall Summary
| Recall Number | Z-1207-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 23, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | CareFusion 303, Inc. |
| Location | San Diego, CA |
| Product Type | Devices |
| Quantity | 229 MedFlex and 3,154 spare Bio-ID spare parts |
Product Description
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.
Reason for Recall
Due to fingerprint scanner failing resulting in the scanner heating up.
Distribution Pattern
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.
Lot / Code Information
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 16412201 16412202 16412203 16412204 16413409 16413413 16413414 16413415 16413416 16413417 16413418 16413419 16413420 16413421 16416112 16416513 16416514 16416515 16416516 16416517 16416521 16416522 16416523 16416524 16416525 16423188 16423191 16423192 16423194 16423195 16445044 16445048 16445052 16445058 16446397 16450291 16455056 16455110 16461396 16461398 16461401 16461411 16468079 16468080 16468081 16468082 16468196 16468197 16468198 16468199 16468200 16469897 16474392 16479191 16488020 16503686 16527419 16550170 16574848 16598590 16598591 16601178 16604645 16612167 16612169 16620622 16620623 16620624 16620654 16626427 16626428 16641391 16650692 Bio-ID Spare Part Catalog Number: 353200-01 UDI-DI code: 10885403450136 No Serial/Lot Numbers provided since BD CareFusion is not the manufacturer of the spare parts.
Other Recalls from CareFusion 303, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1645-2026 | Class II | BD Alaris" System with Guardrails" Suite MX wit... | Feb 11, 2026 |
| Z-1028-2026 | Class II | BD Pyxis ES Enterprise Server Catalog Numbers 1... | Dec 3, 2025 |
| Z-0962-2026 | Class II | BD Pyxis MedStation ES, REF: 323, BD Pyxis M... | Nov 20, 2025 |
| Z-1217-2026 | Class II | BD Alaris" Pump Module model 8100 UDI-DI code:... | Nov 6, 2025 |
| Z-0430-2026 | Class I | BD Alaris infusion Pump Module 8100, REF: 8100;... | Oct 17, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.