Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"
FDA Recall Z-1650-2026 · Posted 2026-03-27
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Recalling FirmMedline Industries, LP
Recall StatusOpen, Classified
Product CodeKGN
Date Initiated2026-02-10
Product Quantity106,621 US; 2,350 OUS
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.
Firm Action
Firm began notifying customers on 2/10/26 via "Urgent Medical Device Recall" letters.
Customers were instructed to immediately locate and quarantine all affected product. Affected product must be destroyed. Customer should respond to the firm to confirm quantity of affected product in inventory. The customer will receive credit from the firm once the response is submitted.
Distributors should notify any of their affected downstream accounts.
If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
Domestic distribution nationwide US. International distribution to Mexico and Panama.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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