The Recall Desk

FDA (Devices) recall action 86777

Boston Scientific Corporation recalled 37 products on 2020-12-30

The FDA (Devices) publishes a recall like this one as 37 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 37 pages.

Products
37
Announced
2020-12-30
Critical
0
Units
76,883

Why these products were recalled

Complaint trend regarding needle shaft gas leaks.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

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