Lower riskMedical device recall · FDA · Published November 30, 2022
Beaver EdgeAhead Stiletto Knife Recall: Risk of Infection from Compromised Sterility
Beaver recalls EdgeAhead Stiletto knives with compromised sterile packaging that could lead to infection during cataract surgery. Affected units have specific part numbers and lot codes.
“Beaver EdgeAhead Stiletto Knife Recall: Risk of Infection from Compromised Sterility.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/59264-beaver-edgeahead-stiletto-knife-recall-risk-of-infection-from-compromised. Based on FDA recall #Z-0782-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0782-2023%22&limit=1).
The FDA announced on 2022-11-30 that Beaver-Visitec International, Inc. is recalling Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G) units due to compromised sterile packaging. The hazard poses a risk of infection from loss of sterility.
Packaged as component of READYPAK KIT Cat: 584896 Lots: 6054175, 6053035
The hazard
The packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility and may lead to infection.
Context
GovInfoNow's records show Beaver-Visitec International, Inc. has 15 other recalls on record since 2017-11-03. Other recent recalls include the Beaver-Visitec OME6000U Laser System Recall (2025-12-05), the Beaver Visitec CustomEyes Procedure Packs: Low Dead Space Syringes Recall (2024-07-26), and the Xstar Safety Slit Knife Recall (2024-05-10). Other recent recalls of similar products include the Medline 5.5" Sterile Scissors Recall (2025-11-13), the Bard Peripheral Vascular Recall: Broviac Cutdown Trays with SureCuff Cuff Risk of Sterile Barrier Compromise (2025-12-12), and the Biomet Intramedullary Bone Saw Blade Recall (2026-07-01).
How to tell if you have this one
Check for part number 376630 or lot number 3391035 on the knife packaging. These knives are also included in READYPAK KIT Cat: 584: 6054175 and 6053035 lots.
Brand
Beaver
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Packaging Integrity
Inspect the knife's packaging for damaged seals or openings that could compromise sterility.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0782-2023 (November 30, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0782-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.