FREEDOMAIRE — Class II medical device recall Z-1339-2015
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-1339-2015 |
|---|---|
| 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 | 153 units |
| Reason classes | labeling |
| Lot numbers | C10025, C10043, C10067, C10165, C10230, C10237, C11321, C11325, C12251, C13063, C13325, C9257, C9324 |
| Model numbers | 1/CS, 11113STK |
Product
FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contamination, body fluids and microorganisms.
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-1339-2015. 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.