Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply Recalled by Hartmann USA, Inc Due to Micro holes were detected in the laminate of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Hartmann USA, Inc directly.
Affected Products
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
Quantity: Lot 101546391 - 200 cs; Lot 101646398 - 200 cs; 101747392 - 120 cs; Lot 101850399 - 160 cs; Lot 101952390 - 240 cs; Lot 200106397 - 200 cs
Why Was This Recalled?
Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Hartmann USA, Inc
Hartmann USA, Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report