HIGH

Medline Puracol Collagen Wound Dressings Recalled for Elevated Endotoxin Levels (2026)

Medline recalled 108,971 units of Puracol MSC8522 and Puracol Plus MSC8622EP collagen wound dressings nationwide in the United States, with distribution to Mexico and Panama. Elevated endotoxin levels were identified in affected lots. Stop using the dressings and follow recall instructions provided by Medline or your healthcare provider.

Quick Facts at a Glance

Recall Date
February 10, 2026
Hazard Level
HIGH
Brand
Medline Industries, LP
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter

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About This Product

Puracol and Puracol Plus are sterile collagen wound dressings used to cover wounds in clinical settings and at home under medical guidance.

Why This Is Dangerous

Elevated endotoxin levels can cause a strong inflammatory response, local irritation, delayed wound healing, fever and hypotension. In severe cases, septic shock can occur.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Public health risk exists for patients treated with recalled dressings. Immediate use stoppage is required to minimize potential adverse events. Hospitals and clinics may need to quarantine affected lots.

Practical Guidance

How to identify if yours is affected

  1. Verify model numbers MSC8522 or MSC8622EP.
  2. Check lot numbers P2090 (MSC8522) or PL2107 (MSC8622EP).
  3. Cross-check UDI-DI numbers: MSC8522 10080196285860 (each) and 40080196285861 (case); MSC8622EP 10080196296804 (each) and 40080196296805 (case).

Where to find product info

UDI-DI codes and lot numbers are printed on packaging and in recall notices.

What timeline to expect

Refunds or replacements typically take 4-8 weeks after submission of recall requests.

If the manufacturer is unresponsive

  • Document all communication with Medline
  • Escalate to healthcare provider and recall resources like FDA if needed

How to prevent similar issues

  • Verify lot numbers and model numbers when receiving wound dressings.
  • Ask suppliers for endotoxin testing documentation when purchasing medical dressings.
  • Maintain a recall-ready inventory system with lot tracking.

Documentation advice

Keep the recall letter, packaging, lot numbers, and any correspondence with Medline; photograph packaging and labels for records.

Product Details

Models: MSC8522 and MSC8622EP\nDescriptions: MSC8522 — Puracol, sterile collagen dressing; MSC8622EP — Puracol Plus, sterile collagen dressing 2 in x 2.2 in (approx.)\nUDI-DI numbers: MSC8522 10080196285860 (each) and 40080196285861 (case); MSC8622EP 10080196296804 (each) and 40080196296805 (case)\nSold in: Domestic distribution nationwide US; international distribution to Mexico and Panama\nQuantity: 108,971 total units (106,621 US; 2,350 outside US)\nSold from: Unknown\nPrice: Unknown

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • Total units recalled: 108,971 (106,621 US; 2,350 outside US)
  • Models: MSC8522, MSC8622EP
  • Lot numbers: P2090 (MSC8522); PL2107 (MSC8622EP)
  • Endotoxin contamination identified in affected lots
  • Recall date: 2026-02-10
  • Status: ACTIVE
View Original Recall on FDA - Medical Devices

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Safety Guide

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Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeWound Dressing, Collagen
Sold At
Multiple Retailers

Product Details

Model Numbers
MSC8522 - Puracol UDI-DI 10080196285860 (each) 40080196285861 (case) Lot P2090 MSC8622EP - Puracol Plus UDI-DI 10080196296804 (each) 40080196296805 (case) Lot PL2107
Affected States
ALL
Report Date
April 1, 2026
Recall Status
ACTIVE

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