BD Pyxis CII Safe Dispensing Cabinets Recalled for Electrical Current Leakage
BD Pyxis CII Safe automated dispensing cabinets may leak excessive electrical current when connected to multi-socket power strips, risking electric shock and system downtime.
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: FDA Class II recall addressing potential electric shock risk from electrical current leakage. The rubric classifies risk-of-harm products without reported injuries as High (3).
Plain-English summary
BD Pyxis CII Safe automated dispensing cabinets with certain software versions (V7, V8, V9, ES, and various reference models) are being recalled due to potential electrical current leakage. When connected to multi-socket outlet power strips, these devices may present unacceptable levels of current leakage.
The hazard could expose users to system downtime and potential electric shock. Approximately 9,906 units have been distributed throughout the United States and internationally. Devices were manufactured between May 4, 2006, and September 26, 2023.
This is a Class II recall issued by the FDA.
The recalled product
- Product
- BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Software: V7, REF: 107-223, 107-224, 111-191, 111-192, 111-193, 111-194, 111-195, 111-196, 111-197, 111-198; BD Pyxis CII Safe, Software: V8, 111-199-01, 111-200-01, 111-201-01, 111-202-01…
- Manufacturer
- CareFusion 303, Inc.
- Affected units
- 9,906
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI-DI: 10885403512520
- Devices Manufactured May 04
- 2006 - September 26
- 2023
Distribution
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