Jadak Barcode Scanner — Class II medical device recall Z-0814-2016
Terminated recall by CareFusion 303, Inc., reported 2016-02-24, distributed nationwide. Customers reported issues when scanning medications with the scanners. When a user scans a medication using th
| Recall number | Z-0814-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 303, Inc., San Diego, CA, United States |
| Recall initiated | 2016-01-15 |
| Classified | 2016-02-16 |
| Reported by FDA | 2016-02-24 |
| Terminated | 2017-05-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BH, BS, MX, QA, SA |
| Quantity | 9,345 units |
| Model numbers | 350587-32, 350587-41, 351377-32 |
Product
Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An accessory for the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations. The Jadak Barcode Scanner is used to scan medication labels during refill of the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations and dispensing medication for patients.
Reason for recall
Customers reported issues when scanning medications with the scanners. When a user scans a medication using the affected barcode scanner, information on a different medication could be communicated to the Pyxis product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0814-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.