FDA Medical devices recall ·
138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI… recall
- Recall number
- Z-1227-2025
- Date
- (initiated January 8, 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
- 6,075 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI CR-4HH-P 169-115 BD PYXIS MEDBANK MINI CR-4HH-P 139001-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FH-P 139002-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FM-P 139000-01 BD PYXIS MEDBANK MN 200 CR-4HH-P 139020-01 BD PYXIS MEDBANK MN 500 CR-2HH-1FM-2DD-P 139018-01 BD PYXIS MEDBANK MN 500 CR-2HH-5FM-P 139019-01 BD PYXIS MEDBANK MN 500 CR-4HH-1FH-3FM-P 139021-01 BD PYXIS MEDBANK MN 500 CR-4HH-4FM-P 139022-01 BD PYXIS MEDBANK MN 500 CR-6HH-3FM-P 138973-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P 155140-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P 169-82 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P 138975-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P 155141-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P 169-83 BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P 139073-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH 155142-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH 169-84 BD PYXIS MEDBANK TWR MN CR-12HH-1FH 138976-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P 155143-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P 169-85 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P 138977-01 BD PYXIS MEDBANK TWR MN CR-14HH-P 155144-01 BD PYXIS MEDBANK TWR MN CR-14HH-P 169-86 BD PYXIS MEDBANK TWR MN CR-14HH-P 138951-01 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM 155145-01 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM 169-87 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM 139072-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FH 155146-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FH 169-88 BD PYXIS MEDBANK TWR MN CR-2HH-6FH 139085-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FM 155147-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FM 169-89 BD PYXIS MEDBANK TWR MN CR-2HH-6FM 138968-01 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P 155148-01 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P 169-90 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P 138964-01 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P 155149-01 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P 169-91 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P 138966-01 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P 155150-01 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P 169-92 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P 138967-01 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P 155151-01 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P 169-93 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P 138969-01 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P 155152-01 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P 169-94 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P 138965-01 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P 155153-01 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P 169-95 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P 138971-01 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P 155154-01 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P 169-96 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P 138972-01 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P 155155-01 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P 169-97 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P 138974-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P 155156-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P 169-98 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P 138970-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P 155157-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P 169-99 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P
Why was it recalled?
Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
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
MEDFLEX 1119-00 10885403512704 MEDFLEX 2.0 1139-00 10885403512704 MEDBANK TOWER MAIN 1145-00 10885403517167 MEDBANK MINI MAIN 1147-00 10885403517181 BD PYXIS MEDBANK MINI 2FH 138902-01 N/A BD PYXIS MEDBANK MINI 2FM 138903-01 N/A BD Pyxis MedBank Twr Mn 4HH-8HM-1FM 138905-01 N/A BD PYXIS MEDBANK MINI 2HH-1FM 138906-01 N/A BD PYXIS MEDBANK MINI 2HH-2HM 138907-01 N/A BD PYXIS MEDBANK MINI 2HH-1FH 138908-01 N/A BD PYXIS MEDBANK MINI 3HH-1HM 138909-01 N/A BD PYXIS MEDBANK MINI 4HH 138910-01 N/A BD PYXIS MEDBANK MINI CR-4HH-P 138911-01 N/A BD PYXIS MEDBANK MINI 1HH-3HM 138912-01 N/A BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138913-01 N/A BD Pyxis MedBank Twr Mn 5HH-9HM 138914-01 N/A BD PYXIS MEDBANK MINI 4HM 138915-01 N/A BD PYXIS MEDBANK TWR MN 4HM-5FM 138916-01 N/A BD PYXIS MEDBANK TWR MN 4HH-5FH 138917-01 N/A BD PYXIS MEDBANK TWR MN 4HH-5FM 138918-01 N/A BD PYXIS MEDBANK TWR MN 2HH-6FM 138919-01 N/A BD PYXIS MEDBANK TWR MN 7FH 138920-01 N/A BD PYXIS MEDBANK MINI 1HH-1FH-1HM 138921-01 N/A BD PYXIS MEDBANK TWR MN 6HH-4FM 138922-01 N/A BD PYXIS MEDBANK TWR MN 8HH-3FM 138923-01 N/A BD PYXIS MEDBANK TWR MN 10HH-2FM 138924-01 N/A BD PYXIS MEDBANK TWR MN 12HH-1FM 138926-01 N/A BD PYXIS MEDBANK TWR MN 14HH 138927-01 N/A BD PYXIS MEDBANK TWR MN 4HH-2HM-4FM 138929-01 N/A BD PYXIS MEDBANK TWR MN 4HH-2HM-4FM 138930-01 N/A BD PYXIS MEDBANK TWR MN 4HH-2FH-3FM 138931-01 N/A BD PYXIS MEDBANK TWR MN 2HH-1FH-5FM 138932-01 N/A BD PYXIS MEDBANK TWR MN 3FH-4FM 138933-01 N/A BD PYXIS MEDBANK TWR MN 4HH-1FH-
Distribution
US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, 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-1227-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.