Reported Jan 29, 2025 · Ongoing
Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
Adept Medical Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Adept Medical Ltd · 2-6 Mc Donald Street · Auckland · N/A
Is this the product you have?
- Otological Ventilation Tube - Donaldson - Double - Blue Silicone
- Product CodeNZ3321-2
- Lot codes and dates
- Product CodeNZ3321-2
- UDI-DI09421901970413
- Lots
2015-42222016-48932016-52362016-54082017-55382017-57902017-60472017-62332018-63612018-67352019-69702022-104512023-11068
- Amount recalled
- 4,080 units (1510 US, 2570 OUS)
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
Lack of 510(k) clearance.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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