bvi Beaver Optimum Safety Sideport Knife: — Class II medical device recall Z-0504-2018
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 The protective shield was retracted, and the blade was exposed.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-0504-2018 |
|---|---|
| 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 | 526,220 units |
| Lot numbers | 3178391, 3178790, 3178798, 3180595, 3181021, 3182013, 3182049, 3182235, 3182410, 3182650, 3183147, 3183491, 3183519, 3184232, 3184328, 3184542, 3184672, 3184816, 3184965, 3185034, 3185252, 3185255, 3186417, 3186420, 3186576, 3187180, 3187184, 3187502, 3188578, 3188621, 3188934, 3189052, 3189182, 3189320, 3189327, 3189737, 3190021, 3190106, 3190109, 3190445 and 145 more |
| Model numbers | 378235, 378236, 378237, 378238 |
Product
bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o, REF 378235 (b) Straight 22.5o, REF 378236 (c) Straight 30o, REF 378237 (d) Straight 45o, REF 378238 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The protective shield was retracted, and the blade was exposed.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-0504-2018. 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.