{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Waltham", "state": "MA", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "78789", "recalling_firm": "Beaver-Visitec International Inc.", "address_1": "411 Waverley Oaks Rd Ste 229", "address_2": "", "postal_code": "02452-8422", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "E-Mail", "distribution_pattern": "Worldwide Distribution - US Nationwide and the countries of Italy, UK, Finland, Germany, Ireland, Turkey", "recall_number": "Z-0502-2018", "product_description": "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ENT and other surgical applications.", "product_quantity": "659,370 units", "reason_for_recall": "The protective shield was retracted, and the blade was exposed.", "recall_initiation_date": "20171103", "center_classification_date": "20180201", "termination_date": "20230531", "report_date": "20180207", "code_info": "(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 3205726 3205770 3206530 3207513 3208063 3208993 3209857 3210484 3211156 3211282 3211748 3211760 3212317 3212320 3212918 3212921 3213343 3213360 3213572 3213568 3214547 3214982 3215417 3216334 3216347 3216366 3216367 3216481 3216482 3217304 3218758 3218811 3218146 3218149 3217942 3219428 3219437 3220200 3220927 3221066 3221697 3222506 3223301 3224278 (i) REF 378227; Batch numbers: 3182233 3183515 3184330 3185040 3186411 3187181 3188329 3188619 3189318 3189329 3189912 3190034 3190555 3192405 3193052 3193361 3193982 3194788 3195449 3194783 3195885 3196461 3196860 3197492 3197595 3198224 3198294 3198621 3198627 3199940 3200588 3201024 3201733 3201849 3202090 3202459 3203359 3204290 3204734 3205082 3205822 3207126 3207132 3207742 3208686 3210619 3209863 3211211 3211288 3211889 3212202 3213018 3213021 3213469 3213558 3213562 3213680 3213733 3215069 3216000 3216473 3216499 3217750 3219030 3218186 3219551 3220682 3221068 3221778 3222509 3223254 3224673 (j) REF 378228; Batch numbers: 3180426 3180934 3181558 3182047 3183926 3184541 3184814 3185055 3186255 3186406 3185246 3187500 3188185 3188186 3188644 3190544 3190850 3190858 3192146 3193342 3193380 3193985 3194982 3194994 3195888 3196678 3195608 3197682 3198107 3198219 3198700 3199804 3200528 3200630 3201048 3201958 3201961 3202763 3202769 3203231 3203652 3204369 3204738 3204834 3205577 3206685 3207819 3210261 3211215 3211716 3212006 3211892 3212613 3212615 3212802 3212806 3213362 3213365 3213575 3213682 3214545 3214983 3215301 3215409 3215758 3215873 3216003 3216037 3216041 3216414 3215431 3215446 3215449 3215458 3216474 3216475 3216496 3216497 3216498 3218426 3218554 3218815 3219033 3217983 3217988 3218017 3219429 3219449 3221773 3222621 3223306 3224938 (k) REF 378230; Batch numbers: 3180429 3181847 3184088 3185238 3187744 3188557 3192936 3194090 3196702 3199215 3201173 3202915 3204379 3205671 3206267 3206703 3208786 3210379 3211275 3211721 3213683 3213687 3215422 3216476 3218193 3219981 3220931 3221097 3221095 3221096 3222344 3225236 (l) REF 378232; Batch numbers: 3202917 3209398 3213734 3218192 3224262 (m) REF 378822; Batch numbers: 3179523 3187936 3188556 3192817 3194780 3198853 3199661 3200595 3201369 3203654 3205829 3207730 3208980 3211285 3212021 3213712 3216006 3216421 3220308 3221086 3222512 3224265 (n) REF 378824; Batch numbers: 3181689 3182411 3182485 3185035 3186135 3188478 3188931 3191980 3193376 3195414 3197672 3198292 3199245 3200250 3201846 3203590 3204387 3205078 3206698 3207816 3208153 3210259 3210572 3211177 3211887 3212020 3213713 3218556 3218687 3213714 3219028 3219036 3220314 3220679 3219656 3221063 3222869 3224021 (o) REF 378825; Batch numbers: 3181209 3187969 3191343 3195689 3198945 3200885 3202146 3213715 3217379 3220810 3223054 (p) REF 378826; Batch numbers: 3185051 3199933 3207540 3213009 3216368 3219653 3223341 (q) REF 378827; Batch numbers: 3180033 3181022 3182673 3188488 3191723 3192142 3195870 3198221 3200396 3203646 3206380 3207510 3210578 3212312 3214543 3217380 3225021 3225218 (r) REF 378828; Batch numbers: 3180044 3182653 3192247 3195874 3197728 3201180 3203674 3206259 3208116 3211179 3213015 3217381 3219976 3222351 3223342 (s) REF 378829; Batch numbers: 3181208 3188581 3193375 3199223 3203955 3207245 3211273 3215755 3219650 3223303 (t) REF 378830; Batch numbers: 3198295 3217382 3219643 3223116 (u) REF 378832; Batch numbers: 3180337 3199934 3216477 (v) REF 370145; Batch numbers: 3180038 3181213 3184311 3186826 3189785 3189618 3190862 3191351 3192814 3193831 3195007 3196691 3198015 3199083 3199249 3200038 3201727 3203362 3205097 3206098 3206978 3208683 3209710 3211279 3213731 3213667 3215062 3215101 3216365 3217359 3218817 3222058 3222624 3223802 3223257 3223763 3223817 (w) REF 370146; Batch numbers: 3180041 3182412 3188933 3192298 3194670 3197603 3200635 3203951 3207868 3209373 3210618 3215412 3218143 3220068 3222861 (x) REF 373025; Batch numbers: 3182006 3205072 3211218 3215753 3218690 3220928 (y) REF 373032; Batch numbers: 3180597 3204042 3206983 3216349 3222360 3223823", "more_code_info": "" } ] }