FDA recall, , Moderate risk
Puracol and Puracol Plus Collagen Wound Dressings
Puracol and Puracol Plus Collagen Wound Dressings have elevated endotoxin levels that may cause strong inflammatory response.
Summary by Recall Canary from the FDA notice
What happened
Medline Industries, LP, of Northfield, Illinois, recalled Puracol and Puracol Plus Collagen Wound Dressings because elevated endotoxin levels were identified in affected lots. The issue may elicit a strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases, septic shock may result.
The company began the recall on February 10, 2026, and the FDA classified it on March 26, 2026. The products were distributed nationwide in the US, with international distribution to Mexico and Panama.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Puracol and Puracol Plus Collagen Wound Dressings
- UDI-DI
- 10080196285860
- 40080196285861
- 10080196296804
- 40080196296805
- Lot code
- P2090
- MSC8622EP
- PL2107
Recall details
- Company began the recall
- Sold in
Domestic distribution nationwide US. International distribution to Mexico and Panama.
- Company
- Medline Industries, LPNorthfield, Illinois
- Hazard
- Contamination
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98484
- Recall number
- Z-1650-2026
- Quantity recalled
- 106,621 US; 2,350 OUS
All recalls from Medline Industries, LP
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Classified by FDA
Added to FDA's Enforcement Report
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
