CLASS II Device recall · Reported 7 Feb 2018 · FDA Enforcement Report
bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o recalled
Beaver-Visitec International is recalling bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o, distributed nationwide in the US. The recall was initiated on 3 Nov 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0504-2018
- FDA event ID
- 78789
- Recalling firm
- Beaver-Visitec International, Waltham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Nov 2017
- FDA classified
- 1 Feb 2018
- Reported
- 7 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 3 Nov 2017 | Recall initiated by company | |
| 1 Feb 2018 | Classified by FDA | +90 days |
| 7 Feb 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The protective shield was retracted, and the blade was exposed.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - US Nationwide and the countries of Italy, UK, Finland, Germany, Ireland, Turkey
Questions about this recall
Is bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o recalled?
Yes. Beaver-Visitec International recalled bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o on 3 Nov 2017. The recall is Class II and its status is Terminated. Recall number Z-0504-2018.
Why was it recalled?
The protective shield was retracted, and the blade was exposed.
Which lots are affected?
(a) REF 378235; Batch Numbers: 3178790 3178798 3181021 3182013 3182049 3182235 3182410 3183147 3183491 3184232 3184328 3184542 3184672 3185034 3185252 3185255 3186417 3186576 3187180 3187184 3186420 3188578 3188934 3189052 3189182 3189737 3190021 3190109 3189327 3188621 3190106 3190445 3191354 3192246 3192299 3194092 3194677 3194682 3192938 3195465 3196317 3196440 3197168 3197489 3197708 3198293 3199225 3199085 3199802 3199941 3200524 3200530 3201178 3201335 3201365 3201960 3202666 3202669 3202765 3202913 3203583 3203592 3204380 3204388 3204979 3204982 3205578 3205672 3206386 3206161 3206381 3207128 3207240 3207398 3207817 3208681 3208598 3208787 3208688 3209396 3209400 3209711 3210573 3210579 3210582 3211278 3211281 3211283 3211888 3211890 3212316 3212605 3212616 3212603 3213561 3213565 3213567 3213570 3213576 3213573 3214549 3214979 3215040 3215042 3215419 3215423 3215432 3215447 3215450 3216355 3216356 3216357 3216358 3216359 3216373 3216374 3216375 3216376 3218684 3218688 3218759 3216411 3217943 3217987 3218014 3218016 3218187 3218190 3218422 3219305 3219443 3219649 3219652 3219655 3220258 3220307 3220310 3220313 3220315 3221064 3221067 3221080 3222054 3222057 3222346 3223344 3223258 3223801 3224017 3224018 3224277 3224279 3225022 3225237 3225438 (b) REF 378236; Batch Numbers: 3178391 3184965 3196580 3203645 3212919 3218813 3222350 (c) REF 378237; Batch Numbers: 3180595 3183519 3184816 3187502 3189320 3190464 3193379 3196687 3197494 3202092 3204844 3209713 3212319 3213560 3213711 3215459 3219549 3221085 3223256 (d) REF 378238; Batch Numbers: 3182650 3199216 3208791 3219552
Where was it sold?
Worldwide Distribution - US Nationwide and the countries of Italy, UK, Finland, Germany, Ireland, Turkey
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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