FDA Medical devices recall · February 5, 2025

BD Pyxis MedStation ES AUX Tower recall

Read the official FDA notice ↗

Product

BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedStation 4000 are automated dispensing cabinets (ADC) that are intended to securely store and dispense medications to a qualified and authorized healthcare provider.

Why was it recalled?

Due to an increase in complaints of door latch assembly failures that may cause the doors to be left in an open state potentially causing inventory discrepancies, a delay in access to medication and/or diversion of medication.

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 MedStation ES AUX Tower Catalog Number: 343 UDI-DI code: 10885403512698 Serial Number/Equipment Number: 14535900 14535900 14535901 14535901 14535902 14535902 14535903 14535903 14535904 14535904 14535905 14535905 14535906 14535906 14535907 14535907 14535908 14535908 14535910 14535910 14535912 14535912 14535913 14535913 14535916 14535916 14535919 14535919 14535922 14535922 14535924 14535924 14535926 14535926 14535928 14535928 14535930 14535930 14535932 14535932 14535934 14535934 14535936 14535936 14535937 14535937 14535939 14535939 14535941 14535941 14535943 14535943 14535945 14535945 14535947 14535947 14535949 14535949 14535951 14535951 14535953 14535953 14535954 14535954 14535956 14535956 14535958 14535958 14535960 14535960 14535962 14535962 14535964 14535964 14535966 14535966 14549572 14549572 14549573 14549573 14549574 14549574 14549575 14549575 14549576 14549576 14549577 14549577 14651270 14651270 14651271 14651271 14651282 14651282 14651297 14651297 14651298 14651298 14651299 14651299 14651314 14651314 14651315 14651315 14651316 14651316 14651317 14651317 14651357 14651357 14651358 14651358 14651359 14651359 14651390 14651390 14703129 14703129 14703130 14703130 14703131 14703131 14735444 14735444 14735445 14735445 14735446 14735446 14735447 14735447 14735448 14735448 14753109 14753109 14753111 14753111 14753112 14753112 14753126 14753126 14753127 14753127 14753128 14753128 14753129 14753129 14753130 14753130 14753131 14753131 14753132 14753132 14753145 14753145 1

Distribution

U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Germany and Japan

States: Alaska Alabama Arkansas 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 North Dakota Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island 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-1050-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.