Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 24, 2016
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.
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 co…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
CareFusion 303, Inc. recalled Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An… - a moderate-severity action.
Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An… was recalled by CareFusion 303, Inc. in February 24, 2016. Reason: Customers reported issues when scanning medications with the scanners. When a user scans a medication using …. Check the official notice for the remedy. Verify recall #Z-0814-2016 with the FDA Devices before acting.
The recall
CareFusion 303, Inc. issued this moderate-severity FDA Devices recall-Customers reported issues when scanning medications with the scanners. When a user scans a medication using ….
- Moderate
- severity level
- 9K units
- affected scope
- Class II
- classification
- February 24, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0814-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0814-2016) was formally reported on February 24, 2016, with the manufacturer initiating the action on January 15, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. CareFusion 303, Inc. is listed as the recalling firm, operating out of San Diego, CA. Federal records list the affected scope as 9,345 units.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide:Distribution - US Nationwide and the countries of Saudi Arabia, Bahrain, Australia, United Arab Emirates, Qatar, Mexico, Guam and the Bahamas.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
9,345 units
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0814-2016 |
| Date reported | February 24, 2016 |
| Date initiated | January 15, 2016 |
| Recalling firm | CareFusion 303, Inc. |
| Firm location | San Diego, CA |
| Affected scope | 9,345 units |
| Distribution | Worldwide:Distribution - US Nationwide and the countries of Saudi Arabia, Bahrain, Australia, United Arab Emirates, Qatar, Mexico, Guam and the Bahamas. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0814-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by CareFusion 303, Inc.. Units affected: 9,345 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 24, 2016. Severity: Moderate. Recall number: Z-0814-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide:Distribution - US Nationwide and the countries of Saudi Arabia, Bahrain, Australia, United Arab Emirates, Qatar, Mexico, Guam and the Bahamas..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0814-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 24, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.