Puracol Collagen Wound Dressings Recalled for Elevated Endotoxin Levels
Summary
Medline Industries issued a Class II recall for Puracol and Puracol Plus Collagen Wound Dressings (MSC8522, MSC8622EP) due to elevated endotoxin levels detected in affected product lots. The affected devices were distributed nationwide in the US and internationally to Mexico and Panama. Use of contaminated dressings may cause severe inflammatory responses including tissue irritation, delayed wound healing, fever, hypotension, and potentially septic shock.
What changed
Medline Industries initiated a Class II recall for Puracol and Puracol Plus Collagen Wound Dressings due to elevated endotoxin levels identified in affected product lots. Affected catalog numbers include MSC8522 (2" x 2" sterile collagen dressing) and MSC8622EP (Puracol Plus 2" x 2.2"). Products were distributed domestically across the US as well as to Mexico and Panama.
Healthcare providers, wound care clinics, and distributors should immediately cease using and quarantine all affected product lots. Patients who have been treated with these dressings should be monitored for signs of inflammatory response, infection, or systemic symptoms. Failure to remove contaminated devices from clinical use could expose providers to adverse event reporting obligations and product liability claims. Medline is expected to provide return instructions for affected inventory.
What to do next
- Cease use of all Puracol and Puracol Plus Collagen Wound Dressings from affected lots
- Quarantine and segregate all affected product inventory to prevent inadvertent use
- Report any adverse patient events potentially related to contaminated dressings to Medline and FDA
Penalties
Class II recall; no direct financial penalty but significant liability exposure for continued use of contaminated devices
Archived snapshot
Apr 9, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Medline Industries, LP
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1650-2026 · 20260401 · Ongoing
Product
Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"
Reason for Recall
Elevated endotoxin levels identified in affected lots. Issue may elicit 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.
Distribution
Domestic distribution nationwide US. International distribution to Mexico and Panama.
Source: openFDA Enforcement API
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