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Puracol and Puracol Plus Collagen Wound Dressings
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MEDICAL DEVICE RECALLMODERATE

Puracol and Puracol Plus Collagen Wound Dressings

Medline is recalling Puracol and Puracol Plus wound dressings due to elevated endotoxin levels that may cause severe inflammatory responses.

What to do

Immediately stop using the affected wound dressings and contact Medline Industries, LP for return and replacement instructions.

Recalled
Listed
Updated
Recall No.
Z-1650-2026
Agency
FDA
Firm
Medline Industries, LP
Recall ID
98484
Status
ONGOING

Recall at a glance

Quantity recalled
106,621 US; 2,350 OUS

Why it was recalled

Medline is recalling specific lots of Puracol and Puracol Plus collagen wound dressings due to elevated endotoxin levels. Use of these products may cause a strong inflammatory response, including local tissue irritation, delayed wound healing, fever, hypotension, or in severe cases, septic shock. The products were distributed nationwide.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Puracol and Puracol Plus Collagen Wound Dressings

UDI-DI
10080196285860, 40080196285861, 10080196296804, 40080196296805

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification