Tecfen Medical recalls Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: Q…
Reason for recall
Sterility assurance for Ophthalmic knives.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 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. Stab knives are used to make precise and fluid tight incisions during eye surgeries such as cataract procedures, vitreoretinal surgery, glaucoma surgery, corneal surgery, and oculoplastic procedures. Component: NoUDI 008176180212864 affected lots2024-11-252027-11-24ZGY23100713-0100817618021286
What the firm is doing
On April 29, 2025, Tecfen Medical initiated a "Urgent Medical Device Recall" Notification to affected consignees via mail and e-mail. Tecfen asked consignees to take the following steps: 1 Please immediately quarantine these Tecfen Medical ophthalmic knife lots. You will receive instructions on how to return them to Tecfen Medical. 2. Please complete the attached medical device recall return response acknowledgement and receipt form by fax to 1-805-967-1295 or email to christina@tecfen.com 3. For any questions, please call 1-805-967-1153, Monday through Friday, 8:00 AM -5:00 PM PST. Alternately, Tecfen can be contacted through email at christina@tecfen.com.
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1949-2025
- FDA device classification · HNNOfficial FDA classification for this device type
- CFR regulation · 21 CFR 886.4350The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Tecfen MedicalSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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