bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o
Medical device recall Z-0504-2018. Published in FDA’s Enforcement Report on Feb 7, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Feb 7, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 526,220 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The protective shield was retracted, and the blade was exposed.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
526,220 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
(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…
Every code shown here, 1,603 characters
(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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - US Nationwide and the countries of Italy, UK, Finland, Germany, Ireland, Turkey
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 3, 2017.
- FDA classified it on Feb 1, 2018.
- FDA’s Enforcement Report published it on Feb 7, 2018.
- FDA terminated it on May 31, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Beaver-Visitec International Inc., of Waltham, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.