CLASS II ONGOING Device recall · Reported 18 Jun 2025 · FDA Enforcement Report
Slit Knife, Angled recalled by Tecfen Medical
Tecfen Medical is recalling Slit Knife, Angled, distributed nationwide in the US. The recall was initiated on 25 Apr 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1955-2025
- FDA event ID
- 96872
- Recalling firm
- Tecfen Medical, Santa Barbara, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Apr 2025
- FDA classified
- 11 Jun 2025
- Reported
- 18 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Medical Software
Timeline
| 25 Apr 2025 | Recall initiated by company | |
| 11 Jun 2025 | Classified by FDA | +47 days |
| 18 Jun 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sterility assurance for Ophthalmic knives.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalog Number: QKN3261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyvek 1059B. Slit knives are used to create precise incisions for controlled entry into the eye. Component: No
Where it was distributed
Worldwide - US Nationwide distribution in the states of Connecticut and Minnesota. The countries of Dominican Republic, Saudi Arabia, Mexico, Chile, Iran, South Africa, Honduras, UAE, Honduras, Qatar, Iran, and Bangladesh, Brazil and Israel.
Questions about this recall
Why was it recalled?
Sterility assurance for Ophthalmic knives.
Which lots are affected?
Lot Code: Manufacture date: 2024-11-21 Expiration date: 2027-11-20 Lot number: ZGY24022804-05 UDI: 00817618021224
Where was it sold?
Worldwide - US Nationwide distribution in the states of Connecticut and Minnesota. The countries of Dominican Republic, Saudi Arabia, Mexico, Chile, Iran, South Africa, Honduras, UAE, Honduras, Qatar, Iran, and Bangladesh, Brazil and Israel.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 96872| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Crescent Knife Angled Bevel Up recalled by Tecfen Medical | Tecfen Medical | Sterility | Nationwide | |
| CLASS II | 15 degree Stab Knife recalled by Tecfen Medical | Tecfen Medical | Sterility | Nationwide | |
| CLASS II | Slit Knife, Angled recalled by Tecfen Medical | Tecfen Medical | Sterility | Nationwide | |
| CLASS II | MVR Sideport Knife Straight recalled by Tecfen Medical | Tecfen Medical | Sterility | Nationwide | |
| CLASS II | Slit Knife, Angled recalled by Tecfen Medical | Tecfen Medical | Sterility | Nationwide | |
| CLASS II | Slit Knife, Angled recalled by Tecfen Medical | Tecfen Medical | Sterility | Nationwide |
More recalls from Tecfen Medical
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Slit Knife, Angled recalled by Tecfen Medical | Tecfen Medical | Sterility | Nationwide |
| Device | CLASS II | Slit Knife, Angled recalled by Tecfen Medical | Tecfen Medical | Sterility | Nationwide |
| Device | CLASS II | MVR Sideport Knife Straight recalled by Tecfen Medical | Tecfen Medical | Sterility | Nationwide |
| Device | CLASS II | Slit Knife, Angled recalled by Tecfen Medical | Tecfen Medical | Sterility | Nationwide |
| Device | CLASS II | 15 degree Stab Knife recalled by Tecfen Medical | Tecfen Medical | Sterility | Nationwide |
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| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |