FDA Medical Device Recalls (openFDA)
Medline Industries, LP: Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"
- Recall number
- Z-1650-2026
- Recalling firm
- Medline Industries, LP
- Product
- Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"
- Status
- Open, Classified
- Initiated
- 2026-02-10
- Posted
- 2026-03-27
- Terminated
- not on file
- Reason
- 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
- 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 recalls@medline.com.
- Quantity
- 106,621 US; 2,350 OUS
- Distribution
- Domestic distribution nationwide US. International distribution to Mexico and Panama.
- Lot, serial or model codes
- MSC8522 - Puracol UDI-DI 10080196285860 (each) 40080196285861 (case) Lot P2090 MSC8622EP - Puracol Plus UDI-DI 10080196296804 (each) 40080196296805 (case) Lot PL2107
- 510(k) numbers
- ["K060456"]
- PMA numbers
- not on file
- Product code
- KGN
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28