Tecfen Medical 2.4mm Slit Knife Sterility Assurance Recall
Tecfen Medical is recalling 115 units of the 2.4mm Slit Knife, Angled (Model QKN2461), an ophthalmic surgical instrument, due to sterility assurance concerns.
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 medical device recall for a high-risk surgical instrument used in ophthalmic procedures. While no illnesses or injuries have been reported, sterility failure of a surgical instrument poses a potential risk of infection during eye surgery.
Plain-English summary
Tecfen Medical is recalling 115 units of its 2.4mm Slit Knife, Angled (Model QKN2461), a manual ophthalmic surgical instrument used to create precise incisions during eye surgery. The recall is due to sterility assurance concerns.
The product is manufactured to be sterile via gamma radiation sterilization and is packaged individually in Tyvek 1059B material. The affected products were manufactured on November 21, 2024, with an expiration date of November 20, 2027 (Lot Number: ZGY24081907-02).
Distribution was worldwide, including the United States (Connecticut and Minnesota), Dominican Republic, Saudi Arabia, Mexico, Chile, Iran, South Africa, Honduras, United Arab Emirates, Qatar, Brazil, and Israel.
No illnesses or injuries related to this recall have been reported. Consumers and healthcare providers in possession of this product should contact Tecfen Medical for further information and instructions.
The recalled product
- Product
- Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knive
- Manufacturer
- Tecfen Medical
- Hazard
- sterility-failure
- infection-risk
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03