RecallRadar

FDA Device recall Z-0502-2018

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 Bev…

On 2018-02-07 the FDA classified a Class II recall of 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1.50mm, 45o Bevel Up (c) REF 378217, 1.7mm, 45o Bev… by Beaver Visitec International, citing the protective shield was retracted, and the blade was exposed.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0502-2018
ClassificationClass II
Statusterminated
Initiated2017-11-03
Published2018-02-07
Last updated2026-09-13 11:54 UTC
CompanyBeaver Visitec International
DistributionUS

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

The protective shield was retracted, and the blade was exposed.

Identifiers

code_info
(a) REF 378214; Batch numbers: 3179722 3185257 3213020 (b) REF 378215; Batch numbers: 3198433 3210262 3219547…(a) REF 378214; Batch numbers: 3179722 3185257 3213020 (b) REF 378215; Batch numbers: 3198433 3210262 3219547 (c) REF 378217; Batch numbers: 3182674 3211158 3216039 (d) REF 378218; Batch numbers: 3182815 3184676 3200039 3206261 3210264 3211159 3220261 3223821 (e) REF 378220; Batch numbers: 3185039 3192148 3192431 3195605 3202095 3211213 3219546 3220981 3223820 (f) REF 378222; Batch numbers: 3179423 3179427 3179529 3179824 3180592 3181031 3180608 3182048 3182463 3182944 3183406 3183517 3184280 3184313 3185036 3185245 3185251 3186142 3186574 3187182 3187974 3187968 3188649 3189553 3190553 3190851 3190861 3191725 3192409 3192250 3191601 3193374 3193835 3194099 3194103 3194993 3195415 3195872 3196579 3197606 3198850 3198855 3198943 3199078 3199248 3199805 3200590 3200593 3201182 3202105 3201337 3202524 3202929 3202156 3203227 3204184 3204292 3205073 3205076 3205727 3205080 3205819 320670

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0502-2018%22

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