FDA Medical devices recall ·
BD Pyxis: MedFlex recall
- Recall number
- Z-1206-2025
- Date
- (initiated January 10, 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
- 1521
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety guides and quick reference guides.
Why was it recalled?
Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving contents/ accessing medications that may result from power loss or potential automated dispensing device malfunctions.
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
User Guides: i. BD Pyxis MedBank Cabinet User Guide v2.4 ii. BD Pyxis MedBank MedPass User Guide v1.0 iii. BD Pyxis MedBank CR Station User Guide v3.10 iv. BD Pyxis MedBank myQLink Cloud Software User Guide v1.5 v. BD Pyxis Supply Cabinet Safety Guide (for SupplyBank models) Quick Reference Guides: i. BD Pyxis MedBank CR Station QRG (part number 155018-03) ii. BD Pyxis MedBank Cabinet QRG (PN 155023-03) iii. BD Pyxis MedBank RxNow CR Station QRG (PN 155026-03) iv. BD Pyxis MedBank RxNow Solution QRG 2.0 (PN 155027-02) v. BD Pyxis MedBank MedPass QRG (PN 155022-03) vi. BD Pyxis MedBank QFill Station QRG (PN 155020-02) vii. BD Pyxis MedBank myQLink Cloud Software QRG 3.0 (PN 155021-02) REF/UDI-DI/Serial Numbers: 1119-00/10885403512704/13517006, 13523350, 13754724, 13767953, 13789575, 13801727, 13826187, 13879544, 13883357, 13884848, 13934472, 13939327, 13948724, 14032802, 14037891, 14158187, 14159916, 14168580, 14172832, 14175162, 14182716, 14202337, 14220872, 14222746, 14228149, 14228150, 14244101, 14254813, 14254816, 14254812, 14254815, 14275112, 14278095, 14317945, 14317946, 14324386, 14332058, 14347747, 14347748, 14349106, 14348708, 14348709, 14352459, 14365786, 14365785, 14374965, 14374963, 14374964, 14377079, 14378428, 14377908, 14407523, 14407524, 14420205, 14420213, 14420211, 14420207, 14420208, 14420206, 14420223, 14420222, 14420212, 14441382, 14442352, 14442359, 14442686, 14442685, 14442585, 14442586, 14445911, 14456782, 14456757, 14458260, 14458256, 14458259, 1447249
Distribution
US Nationwide distribution including in the states of AZ, FL, NJ, KY, GA, CA, IL, MD, WI, OH, NC, MS, NY, MO, PA, OR, IN, TX, UT, OK, MI, WA, AL, NV, ME, WV, NE, DC, MA, MT, KS, CO, TN, IA, MN, AR, ID, SC, SD, CT, HI, VA, ND, AK, NM, VT, LA, WY.
States: Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia 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-1206-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.