Class II — Hartmann USA, Inc
| Recalling firm | HARTMANN USA, INC. |
|---|---|
| Registered facility | HARTMANN USA INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products |
| Product | Hartmann Sterilux Ref 56910000 Sterile Premium 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 |
| Quantity | Lot 102147399 - 421 Cases; Lot 102250396 - 360 Cases; 200105390 - 522 Cases; 200206394 - 390 Cases |
| Distribution | Nationwide distribution: USA including states of: AZ, CA, FL, GA, KY, MO, MS, NC, PA, SC, TN, TX, and VA. |
| Initiated | 2012-05-14 |
| Classified | 2012-06-22 |
| Terminated | 2014-10-06 |
| Recall number | Z-1858-2012 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Hartmann USA, Inc (Z-1858-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/61899/
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