bvi Beaver Xstar Safety Slit Knife: — Class II medical device recall Z-0502-2018
Terminated recall by Beaver-Visitec International Inc., reported 2018-02-07, distributed nationwide. The protective shield was retracted, and the blade was exposed.
| Recall number | Z-0502-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beaver-Visitec International Inc., Waltham, MA, United States |
| Recall initiated | 2017-11-03 |
| Classified | 2018-02-01 |
| Reported by FDA | 2018-02-07 |
| Terminated | 2023-05-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, FI, GB, IE, IT, TR |
| Quantity | 659,370 units |
| Lot numbers | 3179423, 3179427, 3179523, 3179529, 3179722, 3179824, 3180033, 3180038, 3180041, 3180044, 3180337, 3180342, 3180426, 3180429, 3180592, 3180597, 3180608, 3180930, 3180934, 3181022, 3181031, 3181208, 3181209, 3181213, 3181397, 3181558, 3181689, 3181847, 3182006, 3182011, 3182047, 3182048, 3182233, 3182411, 3182412, 3182463, 3182485, 3182653, 3182673, 3182674 and 460 more |
| Model numbers | 1.4MM, 1.50MM, 1.7MM, 1.8MM, 2.0MM, 2.2MM, 2.3MM, 2.4MM, 2.5MM, 2.65MM, 2.6MM, 2.75MM, 2.85MM, 2.8MM, 3.0MM, 3.2MM, 370145, 370146, 373025, 373032, 378214, 378215, 378217, 378218, 378220 and 17 more |
Product
bvi Beaver Xstar Safety Slit Knife: (a) REF 378214, 1.4mm, 45o Bevel Up (b) REF 378215, 1.50mm, 45o Bevel Up (c) REF 378217, 1.7mm, 45o Bevel Up (d) REF 378218, 1.8mm, 45o Bevel Up (e) REF 378220, 2.0mm, 45o Bevel Up (f) REF 378222, 2.2mm, 45o Bevel Up (g) REF 378223, 2.3mm, 45o Bevel Up (h) REF 378224, 2.4mm, 45o Bevel Up (i) REF 378227, 2.75mm, 45o Bevel Up (j) REF 378228, 2.8mm, 45o Bevel Up (k) REF 378230, 3.0mm, 45o Bevel Up (l) REF 378232, 3.2mm, 45o Bevel Up (m) REF 378822, 2.2mm, 45o Double Bevel (n) REF 378824, 2.4mm, 45o Double Bevel (o) REF 378825, 2.5mm, 45o Double Bevel (p) REF 378826, 2.65mm, 45o Double Bevel (q) REF 378827, 2.75mm, 45o Double Bevel (r) REF 378828, 2.8mm, 45o Double Bevel (s) REF 378829, 2.85mm, 45o Double Bevel (t) REF 378830, 3.0mm, 45o Double Bevel (u) REF 378832, 3.2mm, 45o Double Bevel (v) REF 370145, 2.5mm, 45o Bevel Up (w) REF 370146, 2.6mm, 45o Bevel Up (x) REF 373025, kojo, 2.5mm, 45o Bevel Up (y) REF 373032, kojo, 3.2mm, 45o Bevel Up Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
Reason for recall
The protective shield was retracted, and the blade was exposed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0502-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.