BD Pyxis medication dispensing cabinet software issue risks wrong medication access
A software issue in the BD Pyxis CII Safe ES automated dispensing cabinet may cause it to open the wrong medication pocket, risking incorrect medication removal or refills.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall is scored as High because it involves a risk-of-harm product (automated medication dispensing) where patient injury has not yet been reported, per the rubric criterion for score 3. The source text indicates the defect 'may lead to' medication errors but contains no reports of actual illnesses or injuries, making this a theoretical hazard scenario.
Plain-English summary
The BD Pyxis CII Safe ES (REF: 1116-00) is an automated medication dispensing cabinet used in healthcare facilities. A software issue has been identified that may cause the device to open the wrong cubie pocket or position during medication selection and dispensing operations.
This defect creates two risks: unintended and incorrect medication removal by staff, or the potential for a different medication to be pulled in error, refilled, or reloaded into the system. These errors could lead to low medication inventory or complete stockouts, disrupting medication availability for patients.
A total of 218 units have been distributed worldwide, including throughout the United States and internationally. Healthcare facilities using the BD Pyxis CII Safe ES (all software versions, REF 1116-00) should be alert to potential medication dispensing errors until a software remedy is implemented by the manufacturer.
Facilities should contact CareFusion 303, Inc. with any questions or concerns regarding this recall and the availability of a corrective software update.
The recalled product
- Product
- BD Pyxis CII Safe ES, REF: 1116-00
- Manufacturer
- CareFusion 303, Inc.
- Affected units
- 218
Distribution
Part of a larger recall action
This product is one of 3 recalled by CareFusion 303, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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