Novafil Sutures Recalled for Sterile Barrier Breach Risk
Covidien is recalling 48,492 units of Novafil Monofilament Polybutester Sutures due to a sterile barrier breach in the breather pouch that may increase the risk of infection or vision loss during ophthalmic procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of surgical sutures with a sterile barrier breach that may cause infection or vision loss. No illnesses or injuries have been reported in the source text. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Covidien, LP is recalling 48,492 units of Novafil Monofilament Polybutester Sutures across multiple catalog numbers and lot numbers. These sterile surgical sutures are used in various procedures, including ophthalmic (eye) surgeries.
The recalled sutures may have a sterile barrier breach in the breather pouch. This breach could compromise the sterile environment and potentially allow contamination, which may cause infection or vision loss in cases where the sutures come into direct contact with the patient.
This recall affects healthcare facilities and surgical centers across the United States and in more than 50 countries. If you have affected sutures in inventory, you should stop using them immediately and contact Covidien for instructions on returns or replacement products.
The recalled product
- Product
- Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NOVAFIL 3-0 BLU 90CM C14 8886 4400-13 NOVAFIL 6-0 BLU 45CM SBE2 8886 4400-23 NOVAFIL 5-0 BLU 45CM SBE2 8886 440123 NOVAFIL 5-0 BLU 45CM SBE3 8886 4402-33 NOVAFIL 4-0 BLU 45CM SBE4 8886 4403-33 NOVA
- Manufacturer
- Covidien, LP
- Category
- Medical Device — Surgical Suture
- Hazard
- sterile-barrier-breach
- infection-risk
- vision-loss
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 (20)
- GTIN 20884521100821
- 20884521100098
- 10884521100091
- 10884521100299
- 20884521100296
- 20884521099910
- 20884521100814
- 20884521100791
- 20884521100593
- 20884521099965
- 20884521099477
- 20884521100760
- 20884521118345
- 10884521118348
- 20884521099682
- 20884521118406
- 20884521099699
- 20884521100838
- 20884521118390
- 10884521118393
Distribution
Distributed nationwide across the United States.
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