LASER RESISTANT WAND — Class II medical device recall Z-1348-2015
Terminated recall by Microtek Medical Inc, reported 2015-04-08, distributed nationwide. This recall is being conducted because a cohesive band used to package the devices contains latex and the prod
| Recall number | Z-1348-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microtek Medical Inc, Columbus, MS, United States |
| Recall initiated | 2015-03-10 |
| Classified | 2015-03-27 |
| Reported by FDA | 2015-04-08 |
| Terminated | 2017-01-21 |
| Distributed | Nationwide (US) |
| Quantity | 6,540 units |
| Reason classes | labeling |
| Lot numbers | C10102, C10141, C10161, C10326, C10341, C11024, C11055, C11098, C11153, C11215, C11265, C11284, C11326, C11342, C12020, C12101, C12152, C12201, C12276, C12339, C13031, C13100, C13175, C13254, C13291, C14052 |
| Model numbers | 24013 |
Product
LASER RESISTANT WAND - STERILE, 7/8" X 8" (2.22cm x 20.32cm), REF 24013, QTY 10 EA, STERILE EO, NO LATEX Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.
Reason for recall
This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
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-1348-2015. 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.