bvi Beaver Xstar Safety Slit Knife: (a)
Medical device recall Z-0502-2018. 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
- 659,370 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The protective shield was retracted, and the blade was exposed.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 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.
659,370 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
(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…
Every code shown here, 2,000 characters
(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 3206700 3205817 3206272 3206696 3207403 3207501 3207506 3208033 3208816 3208888 3208099 3208146 3208974 3209822 3209858 3210968 3210973 3210979 3211155 3209826 3210377 3210381 3212003 3212018 3212808 3212810 3213467 3213472 3213677 3213678 3214540 3214565 3216348 3215874 3216042 3216469 3216470 3216471 3216472 3218427 3218685 3218755 3218814 3218147 3217984 3218142 3219435 3219430 3220069 3219978 3219979 3220073 3220684 3220977 3221083 3221084 3222359 3222510 3223113 3223114 3223824 3224941 3224267 3225235 (g) REF 378223; Batch numbers: 3191985 3204382 3225442 (h) REF 378224; Batch numbers: 3180342 3181397 3180930 3182011 3183237 3183490 3183520 3184281 3184191 3184675 3184678 3185986 3186249 3185253 3186571 3186418 3187755 3187091 3187938 3187973 3188265 3188613 3188650 3189181 3189910 3189325 3190107 3190112 3190465 3190468 3190548 3191984 3192937 3193341 3193834 3194679 3194680 3195881 3196458 3196859 3197188 3197488 3198017 3198106 3198297 3198431 3199659 3199799 3200259 3200398 3200888 3200892 3201333 3202087 3201721 3202158 3203453 3203648 3204044 3204182 3204610 3204732 3205512 3205515…
FDA’s list runs to 6,022 characters. The first part is shown; the rest is on FDA’s record.
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.”
- FDA’s list of codes runs to 6,022 characters; the first part is shown here, and the rest is on FDA’s record.
- 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.