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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Medline Industries, LP
- Product type
- Wound Dressing, Collagen
- Model numbers
- MSC8522 - Puracol UDI-DI 10080196285860 (each) 40080196285861 (case) Lot P2090 MSC8622EP - Puracol Plus UDI-DI 10080196296804 (each) 40080196296805 (case) Lot PL2107
- Sizes
- 2 in x 2 in, 2 x 2.2 in
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 10, 2026
Reported by FDA DEVICE
April 1, 2026
RecallRadar source check
April 8, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Verify model numbers MSC8522 or MSC8622EP.
- Check lot numbers P2090 (MSC8522) or PL2107 (MSC8622EP).
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.
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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
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Safety Guide
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