SINUVA Sinus Implant Recalled for Failed Drug Release Specification
Intersect ENT, Inc. is recalling 9,898 pouches of SINUVA sinus implants nationwide after detecting failed drug release specifications during stability testing. The implant may not deliver the medication as intended.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III voluntary precautionary recall for a manufacturing quality specification failure with no reported illnesses, injuries, or deaths. The hazard relates to drug release efficacy rather than direct safety risk.
Plain-English summary
Intersect ENT, Inc. is recalling 9,898 pouches of SINUVA (mometasone furoate) sinus implants distributed nationwide. The recall was initiated after the product failed to meet its dissolution specification during a 9-month stability testing timepoint, meaning it did not achieve the average 24-hour drug release rate required.
SINUVA is a prescription sinus implant. The affected lots have specific lot numbers and expiration dates ranging from December 2022 through December 2023, as identified in the FDA recall notice.
If you have received this implant, contact your healthcare provider for guidance. Those with questions about whether their implant is part of this recall should contact Intersect ENT, Inc. or the FDA.
The recalled product
- Product
- SINUVA (MOMETASONE FUROATE)
- Brand
- SINUVA
- Manufacturer
- Intersect ENT, Inc.
- Category
- Drug — Sinus Implant
- Hazard
- Affected units
- 9,898
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- Lot #s: 10111003
- Exp 12/31/2022
- 10203002
- Exp 01/31/2023
- 10302002
- 10325001
- Exp 02/28/2023
- 10519001
- 10526002
- Exp 04/30/2023
- 10602002
- Exp 05/31/2023
- 10819004
- Exp 09/30/2023
- 21092101
- 21111901
- Exp 10/31/2023
- 21110402
- Exp 12/31/2023.
Distribution
Distributed nationwide across the United States.
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