Recall of Puracol and Puracol Plus Collagen Wound Dressings
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Medline Industries is voluntarily recalling certain lots of Puracol and Puracol Plus Collagen Wound Dressings due to elevated endotoxin levels that could cause inflammatory responses and, in severe cases, septic shock.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 9, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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Recall Article
What Happened
Medline Industries, LP is recalling certain lots of Puracol and Puracol Plus Collagen Wound Dressings due to elevated endotoxin levels. This issue may cause a strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension, and in severe cases, septic shock.
Which Products Are Affected
The affected products are Puracol and Puracol Plus Collagen Wound Dressings. Specifically: MSC8522 (DRESSING, COLLAGEN, PURACOL, STRL, 2" X 2") with Lot P2090 and UDI-DI 10080196285860 (each) and 40080196285861 (case); and MSC8622EP (DRESSING, COLLAGEN, PURACOL PLUS, 2X2.2") with Lot PL2107 and UDI-DI 10080196296804 (each) and 40080196296805 (case). A total of 106,621 units are affected in the US, with distribution nationwide in the United States, as well as to Mexico and Panama.
What You Should Do
Consumers who have the affected products should stop using them immediately and contact Medline Industries, LP for instructions, as the recall was initiated via letter. For returns or refunds, reach out to the recalling firm at their address: 3 Lakes Dr, Northfield, IL 60093-2753.
Why This Matters
This recall affects over 100,000 units of medical devices used for wound care, potentially posing serious health risks to patients if the products are used. It underscores the importance of monitoring product safety in the medical devices industry to prevent complications from contaminated items.
Source
FDA recall notice, Recall Number Z-1650-2026. Attribution: FDA website.
Original source: FDA Official Notice ↗
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