bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o
Medical device recall Z-0501-2018. 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
- 572,490 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The protective shield was retracted, and the blade was exposed.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 Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
572,490 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
(a) REF 378210,1.0mm, 45o; Batch numbers: 3180424 3182237 3184226 3184813 3186254 3186824 3188328 3188645 3190859 3193382 3194781 3196464 3198432 3198854 3199803 3200529 3201366 3202916 3204378 3206693 3205820 3207400 3208145 3208991…
Every code shown here, 1,671 characters
(a) REF 378210,1.0mm, 45o; Batch numbers: 3180424 3182237 3184226 3184813 3186254 3186824 3188328 3188645 3190859 3193382 3194781 3196464 3198432 3198854 3199803 3200529 3201366 3202916 3204378 3206693 3205820 3207400 3208145 3208991 3210483 3211178 3212699 3213363 3214566 3215756 3216416 3216492 3218692 3219548 3221087 3222870 3223305 3224266 (b) REF 378212, 1.2mm, 45o; Batch numbers: 3199656 3203358 3206699 3209859 3214567 3219440 3221088 3222865 (c) REF 378231, 115mm, 45o; Batch numbers: 3178327 3179276 3178796 3179272 3180593 3180598 3181976 3182464 3182639 3182046 3183235 3183238 3184099 3184963 3185053 3185244 3186410 3186412 3187088 3187093 3187750 3187757 3188489 3188491 3188618 3189330 3189784 3190033 3190105 3189326 3188579 3190848 3190550 3191722 3191724 3191726 3192143 3192150 3193378 3193381 3194674 3194105 3194681 3194685 3195697 3195871 3196693 3196857 3196858 3197676 3197678 3197729 3197690 3197730 3198018 3198103 3198441 3198699 3198942 3198946 3199082 3199212 3199932 3200397 3200399 3201332 3201334 3201955 3202086 3202525 3202914 3203451 3203455 3204179 3204183 3204291 3204838 3204978 3204981 3205769 3205725 3205773 3206384 3206387 3206533 3207239 3207242 3207374 3208034 3207870 3208031 3208913 3208978 3208982 3209712 3209823 3209855 3210584 3209864 3210258 3210260 3210969 3210972 3211747 3211750 3211761 3212793 3212807 3212803 3213019 3213022 3213346 3213571 3213574 3213577 3214981 3214554 3216350 3216491 3216491 3215759 3215871 3216488 3216489 3216487 3216500 3218555 3218686 3218689 3216501 3219034 3219304 3220070 3220071 3221089 3221090 3221696 3221698 3221772 3222620 3222623 3223345 3223800 3223815 3223255 3223299 3223340
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.