Recall Z-1650-2026— Medline Industries, LP

Name: FDA recall Z-1650-2026
Creator: U.S. Food and Drug Administration
Published: 2026-02-10

Class II · Ongoing

Class II FDA medical device recall by Medline Industries, LP, initiated 2026-02-10. It names one FDA 510(k) clearance: K060456. Product: Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2". 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..

Recalling firm: Medline Industries, LP
Classification: Class II
Status: Ongoing
Initiated: 2026-02-10
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K060456 — MEDLINE COLLAGEN WOUND DRESSINGMedline Industries, Inc.·cleared 2006-06-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.