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Recall of certain lots of the PolyLoop single-use ligation device, reference N5382130, model HX-400U-30, because the ligation loop may fail to release or detach as expected during use, causing the loop to remain unintentionally anchored in place around the patient's anatomy.
Official notice
5 Oct 2026
Last checked
4 Nov 2026
An official AEMPS notice concerns Recall of certain lots of the PolyLoop single-use ligation device, reference N5382130, model HX-400U-30, because the ligation loop may fail to release or detach as expected during use, causing the loop to remain unintentionally anchored in place around the patient's anatomy.. Recall of certain lots of the PolyLoop single-use ligation device, reference N5382130, model HX-400U-30, because the ligation loop may fail to release or detach as expected during use, causing the loop to remain unintentionally anchored in place around the patient's anatomy. Published 2026-10-05.
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Recall number
2026-481
Official notice
2026-10-05
The hazard
The hazard
Recall of certain lots of the PolyLoop single-use ligation device, reference N5382130, model HX-400U-30, because the ligation loop may fail to release or detach as expected during use, causing the loop to remain unintentionally anchored in place around the patient's anatomy.
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How to check if you're affected
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