CLASS II ONGOING Device recall · Reported 1 Apr 2026 · FDA Enforcement Report
Puracol and Puracol Plus Collagen Wound Dressings recalled
Medline Industries is recalling Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 Dressing,Collagen,Puracol,Strl, distributed nationwide in the US. The recall was initiated on 10 Feb 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1650-2026
- FDA event ID
- 98484
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Feb 2026
- FDA classified
- 26 Mar 2026
- Reported
- 1 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 10 Feb 2026 | Recall initiated by company | |
| 26 Mar 2026 | Classified by FDA | +44 days |
| 1 Apr 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"
Where it was distributed
Domestic distribution nationwide US. International distribution to Mexico and Panama.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
MSC8522 - Puracol UDI-DI 10080196285860 (each) 40080196285861 (case) Lot P2090 MSC8622EP - Puracol Plus UDI-DI 10080196296804 (each) 40080196296805 (case) Lot PL2107
Where was it sold?
Domestic distribution nationwide US. International distribution to Mexico and Panama.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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