Elevated endotoxin levels identified in affected lots
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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.
Recall Number
Z-1650-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2026-02-10
Reported
2026-04-01
Distribution
Domestic distribution nationwide US. International distribution to Mexico and Panama.
Code Info
MSC8522 - Puracol UDI-DI 10080196285860 (each) 40080196285861 (case) Lot P2090 MSC8622EP - Puracol Plus UDI-DI 10080196296804 (each) 40080196296805 (case) Lot PL2107
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.