Introduction Pack — Class II medical device recall Z-1557-2015
Terminated recall by Vital Signs Colorado Inc., reported 2015-05-06, distributed nationwide. Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3910 and 3960
| Recall number | Z-1557-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vital Signs Colorado Inc., Englewood, CO, United States |
| Recall initiated | 2015-03-13 |
| Classified | 2015-04-30 |
| Reported by FDA | 2015-05-06 |
| Terminated | 2015-10-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CL, CO, DE, DO, EC, EG, GB, GT, HK, IL, IN, IT, JP, KR, LB, MX, NL, NZ, PA, PE, PL, QA, RU, SI, TR |
| Quantity | 399 |
| Reason classes | sterility |
| Model numbers | 3960 |
Product
Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.
Reason for recall
Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3910 and 3960 due to a potential patient safety risk involving a breach in the sterile packaging that may not be recognized prior to use.
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-1557-2015. 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.