Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24… — Class II medical device recall Z-1857-2012
Terminated recall by Hartmann USA, Inc, reported 2012-07-04, distributed nationwide. Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Ha
| Recall number | Z-1857-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hartmann USA, Inc, Rock Hill, SC, United States |
| Recall initiated | 2012-05-14 |
| Classified | 2012-06-22 |
| Reported by FDA | 2012-07-04 |
| Terminated | 2014-10-06 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| Model numbers | 105, 416, 416105 |
Product
Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing
Reason for recall
Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products
Machine access
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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.