Z-1650-2026Class II

Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP...

Name: Z-1650-2026 Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP...
Creator: Medline Industries, LP
Published: 2026-02-10
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-02-10 / Open, Classified / root cause: sterility

FDA source

Medline Industries, LP began a recall of Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2" on 2026-02-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1650-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-10
Posted: 2026-03-27
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"
Product code: KGN Wound Dressing With Animal-Derived Material(S)
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.
Root cause tag: sterility
FDA root cause: Under Investigation by 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].
Quantity in commerce: 106,621 US; 2,350 OUS
Distribution: Domestic distribution nationwide US. International distribution to Mexico and Panama.
Product codes and lots: MSC8522 - Puracol UDI-DI 10080196285860 (each) 40080196285861 (case) Lot P2090 MSC8622EP - Puracol Plus UDI-DI 10080196296804 (each) 40080196296805 (case) Lot PL2107

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1650-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1650-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-26

Product code KGN

K060456UnclassifiedMedline Collagen Wound DressingMedline Industries, Inc. / cleared 2006-06-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)