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Recalls affecting Kansas

Data last updated: September 9, 2026 at 1:18 PM UTC

16,731 recalls found
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Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

▸Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

▸Full report
Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

American Regent, Inc. — Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

▸Full report
Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

▸Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

▸Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced August 31, 2026

Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

▸Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled November 23, 2020

Naturalyte Liquid Acid concentrate bottles, Product Code 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
86939
Lot/product code:
Lot Numbers: 20LXAC058 20LXAC078 20LXAC096 20NXAC011 20NXAC012  Additional Affected lots as of 3/17/21: 20LXAC060 20NXAC026 20LXAC045 20LXAC043 20LXAC078 20NXAC012 20LXAC058 20LXAC096 20NXAC011 20LXAC059 20LXAC044 20LXAC079
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 23, 2020

Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
86939
Lot/product code:
Lot Numbers: 20LXAC076 20LXAC077 20LXAC091 20LXAC101 20NXAC010  Additional Affected lots as of 3/17/21: 20LXAC053 20LXAC047 20LXAC054 20LXAC049 20NXAC016 20LXAC094 20NXAC024 20NXAC025 20LXAC091 20LXAC101 20LXAC077 20LXAC048 20NXAC010 20LXAC076
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 23, 2020

Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
86939
Lot/product code:
Lot Numbers: 20LXAC025 20LXAC081 20LXAC082 20LXAC083  Additional Affected lots as of 3/17/21: 20LXAC029 20NXAC021 20LXAC026 20LXAC065 20LXAC028 20NXAC029 20LXAC071 20LXAC103 20LXAC027 20LXAC070 20LXAC067 20NXAC019 20LXAC082 20LXAC025 20LXAC081 20LXAC083
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 23, 2020

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids.

There is a potential software error during programming.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
86758
Lot/product code:
Product Code 35700BAX2, GTIN 00085412498683
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 30, 2020

Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno

When the user changes frame rates from lower frequency (e.g. 10 f/s) to higher frequency (e.g. 30 f/s) during continuous release of Fluoro "Fluoro Override", the measured Air Kerma Rate can exceed the regulatory limits.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87026
Lot/product code:
Model number: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purpose- 10094139 Artis zee biplane- 10094141 Artis zeego- 10280959 Artis Pheno- 10849000 Artis Q floor- 10848280 Artis Q ceiling- 10848281 Artis Q biplane- 10848282 Artis Q zeego- 10848283 Artis Q.zen floor- 10848353 Artis Q.zen ceiling- 10848354 Artis Q.zen biplane- 10848355
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 2, 2020

EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

Accelerated battery depletion may result in a need for device replacement earlier than expected.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
86866
Lot/product code:
Serial numbers distributed in the United States:  100371 100467 100485 100548 100591 100641 100705 100710 100717 100742 100745 100791 100866 100868 200019 200023 200031 200043 200049 200067 200125 200126 200127 200128 200129 200152 200157 200161 200163 200167 200170 200171 200176 200181 200182 200185 200186 200187 200190 200191 200192 200195 200198 200214 200217 200224 200228 200232 200236 200239 200241 200244 200247 200251 200256 200258 200261 200262 200264 200266 200269 200276 200283 200287 200290 200291 200293 200297 200300 200301 200313 200317 200330 200331 200333 200335 200341 200347 200348 200351 200358 200359 200360 200366 200367 200368 200369 200370 200372 200373 200374 200375 200378 200381 200382 200384 200386 200388 200389 200390 200391 200394 200398 200402 200403 200406 200410 200422 200423 200425 200426 200428 200431 200435 200436 200437 200441 200442 200444 200445 200448 200449 200452 200453 200461 200465 200468 200469 200470 200471 200473 200479 200481 200482 200488 200491 200493 200497 200503 200506 200510 200511 200515 200517 200518 200519 200524 200527 200533 200535 200536 200543 200545 200546 200553 200554 200555 200556 200557 200563 200564 200567 200574 200575 200577 200579 200580 200584 200585 200587 200588 200589 200590 200591 200592 200593 200595 200598 200599 200600 200604 200605 200606 200607 200620 200624 200625 200628 200629 200631 200634 200636 200637 200641 200642 200645 200648 200651 200654 200656 200657 200658 200659 200663 200665 200667 200669 200671 200677 200679 200680 200683 200684 200685 200688 200689 200691 200692 200693 200696 200698 200702 200703 200704 200705 200707 200712 200713 200716 200717 200718 200719 200721 200723 200726 200727 200729 200730 200738 200739 200740 200741 200742 200743 200745 200746 200747 200748 200749 200750 200752 200753 200754 200755 200760 200761 200762 200763 200770 200775 200777 200778 200779 200782 200783 200786 200787 200794 200800 200801 200802 200803 200805 200806 200810 200811 200812 200814 200815 200818 200821 200822 200824 200825 200831 200832 200833 200836 200838 200839 200841 200842 200843 200844 200848 200854 200856 200865 200867 200869 200871 200874 200882 200887 200888 200889 200891 200892 200893 200896 200899 200903 200905 200906 200909 200910 200911 200913 200914 200917 200919 200923 200925 200927 200928 200930 200933 200934 200939 200945 200946 200950 200953 200954 200957 200961 200965 200966 200968 200970 200971 200972 200973 200979 200983 200986 200988 200990 200991 200992 200995 200996 200997 200998 201001 201002 201006 201009 201010 201011 201012 201013 201016 201017 201021 201024 201027 201028 201031 201032 201033 201034 201036 201041 201044 201045 201047 201048 201049 201050 201054 201055 201061 201062 201063 201064 201067 201069 201070 201071 201074 201075 201076 201077 201078 201079 201080 201084 201085 201086 201089 201090 201092 201095 201096 201098 201099 201100 201103 201104 201107 201108 201110 201112 201114 201116 201118 201119 201123 201124 201125 201126 201127 201131 201133 201134 201135 201137 201139 201143 201144 201146 201147 201148 201149 201150 201151 201152 201153 201156 201157 201160 201161 201165 201166 201167 201168 201169 201170 201171 201172 201173 201174 201176 201177 201178 201179 201180 201182 201187 201188 201189 201191 201192 201193 201194 201195 201196 201197 201198 201200 201203 201205 201206 201207 201208 201209 201210 201211 201212 201213 201214 201215 201216 201218 201219 201220 201221 201222 201223 201225 201226 201231 201232 201233 201234 201237 201238 201239 201240 201242 201243 201245 201246 201247 201248 201251 201252 201253 201254 201255 201256 201258 201259 201264 201265 201266 201267 201268 201269 201270 201272 201273 201274 201276 201277 201278 201279 201280 201281 201282 201283 201284 201286 201287 201288 201290 201291 201292 201293 201294 201295 201296 201297 201298 201299 201300 201301 201303 201306 201307 201308 201309 201312 201314 201315 201316 201318 201319 201320 201322 201323 201324 201325 201326 201328 201329 201331 201332 201333 201335 201337 201338 201339 201340 201341 201342 201343 201345 201346 201348 201349 201353 201396 201400 201402 201404 201405 201406 201408 201409 201410 201413 201416 201419 201420 201421 201422 201423 201424 201428 201431 201434 201435 201436 201438 201439 201440 201441 201444 201451 201452 201454 201456 201459 201460 201462 201463 201464 201466 201467 201468 201471 201476 201477 201479 201480 201481 201486 201487 201488 201491 201498 201501 201510 201512 201513 201514 201515 201516 201517 201521 201525 201533 201534 201537 201539 201544 201545 201548 201551 201554 201555 201556 201557 201558 201562 201563 201564 201565 201567 201568 201570 201571 201572 201579 201580 201581 201585 201587 201589 201592 201598 201599 201600 201602 201606 201612 201619 201622 201623 201626 201631 201634 201637 201640 201641 201642 201643 201645 201646 201648 201651 201655 201658 201661 201662 201664 201667 201677 201678 201679 201684 201685 201686 201687 201688 2… (truncated, 151353 characters total — see the official FDA record for the full value)
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 2, 2020

EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

Accelerated battery depletion may result in a need for device replacement earlier than expected.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
86866
Lot/product code:
Serial numbers distributed in the US:  101624 101701 101757 101808 101835 101845 101869 101878 101946 101953 101957 101958 101960 102009 102048 102055 102060 102061 102074 102079 102081 102096 102120 102129 102177 102178 102183 102190 102194 102195 102196 102205 102220 102239 102251 102272 102277 102307 102319 102334 102383 102384 102403 102406 102409 102416 102418 102426 102428 102432 102438 102441 102452 102473 102491 102495 102505 102522 102535 102536 102540 102543 102546 102550 102557 102558 102561 102564 102565 102568 102571 102573 102574 102575 102576 102577 102578 102581 102583 102585 102586 102587 102589 102590 102593 102594 102595 102596 102597 102598 102599 102602 102603 102609 102615 102616 102617 102618 102620 102622 102625 102626 102627 102628 102630 102638 102641 102642 102645 102647 102648 102650 102651 102652 102655 102657 102658 102660 102661 102662 102664 102666 102667 102668 102670 102673 102674 102675 102677 102678 102679 102680 102683 102684 102685 102686 102687 102688 102689 102690 102691 102692 102693 102694 102695 102696 102697 102698 102699 102701 102702 102703 102705 102707 102709 102713 102714 102717 102721 102723 102724 102725 102726 102727 102728 102730 102731 102732 102734 102735 102736 102737 102738 102739 102740 102741 102742 102745 102746 102748 102749 102750 102754 102755 102756 102757 102758 102759 102762 102763 102764 102765 102766 102767 102771 102772 102773 102774 102777 102778 102779 102780 102782 102783 102786 102787 102788 102790 102793 102794 102796 102797 102802 102806 102810 102812 102813 102814 102815 102816 102818 102819 102820 102821 102825 102826 102827 102829 102830 102831 102832 102833 102834 102835 102837 102838 102840 102845 102846 102847 102851 102853 102854 102858 102859 102860 102861 102864 102865 102866 102867 102868 102869 102870 102871 102873 102874 102875 102876 102877 102878 102879 102880 102882 102883 102884 102885 102886 102889 102890 102892 102893 102894 102895 102897 102898 102901 102903 102904 102905 102906 102907 102908 102909 102910 102911 102912 102913 102916 102919 102921 102925 102926 102929 102930 102931 102932 102933 102934 102935 102936 102938 102940 102941 102943 102945 102946 102947 102948 102949 102951 102952 102954 102955 102960 102961 102962 102963 102964 102965 102967 102968 102974 102975 102977 102979 102982 102983 102984 102985 102986 102989 102991 102992 102995 102996 102997 102999 103000 103001 103003 103004 103005 103007 103008 103010 103014 103018 103019 103024 103025 103028 103029 103030 103031 103032 103033 103034 103038 103039 103040 103043 103044 103045 103047 103048 103049 103050 103052 103053 103055 103056 103057 103061 103062 103064 103065 103066 103067 103068 103070 103071 103072 103073 103074 103075 103078 103079 103081 103082 103083 103084 103085 103088 103090 103092 103095 103096 103097 103098 103099 103100 103101 103102 103104 103105 103106 103107 103108 103109 103110 103111 103113 103117 103118 103119 103122 103124 103125 103128 103132 103133 103135 103138 103139 103140 103141 103142 103143 103144 103145 103146 103149 103150 103151 103153 103157 103158 103160 103161 103162 103163 103165 103166 103167 103168 103169 103170 103171 103172 103173 103174 103175 103176 103177 103178 103179 103180 103181 103184 103203 103204 103206 103207 103208 103209 103211 103212 103214 103215 103216 103217 103220 103222 103223 103225 103226 103227 103229 103230 103231 103235 103236 103237 103240 103242 103245 103246 103247 103248 103249 103250 103251 103252 103254 103256 103257 103258 103259 103261 103262 103263 103264 103266 103267 103269 103271 103272 103273 103275 103276 103278 103279 103280 103282 103284 103287 103291 103292 103293 103296 103297 103298 103302 103303 103304 103306 103310 103311 103313 103314 103315 103319 103320 103321 103322 103325 103326 103328 103330 103331 103333 103334 103337 103338 103345 103346 103348 103349 103350 103351 103354 103355 103356 103358 103359 103360 103362 103364 103366 103367 103368 103371 103372 103384 103386 103387 103388 103389 103390 103393 103394 103396 103397 103399 103401 103402 103403 103405 103407 103410 103411 103415 103416 103417 103418 103421 103422 103423 103427 103428 103429 103430 103431 103433 103434 103436 103437 103439 103441 103444 103445 103446 103450 103451 103452 103453 103454 103455 103457 103458 103463 103465 103467 103469 103472 103473 103477 103478 103481 103488 103491 103493 103494 103496 103498 103500 103504 103510 103515 103517 103520 103532 103537 103539 103544 103545 103548 103551 103552 103553 103557 103558 103560 103562 103564 103565 103567 103568 103580 103583 103584 103587 103597 103601 103602 103603 103606 103608 103610 103612 103618 103619 103627 103631 103635 103637 103647 103651 103654 103656 103661 103678 103689 103705 103712 103714 103723 103781 103783 103794 103800 103846 103851 103861 103874 103887 103890 103893 103904 103911 103912 103924 103938 103955 103959 103966 103971 103972 103981 103985 103990 103996 104004 104007 104017 104020 104079 10408… (truncated, 115620 characters total — see the official FDA record for the full value)
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2020

Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87577
Lot/product code:
UDI Code: 00850000126046 Lot Numbers: 019120G(2) 029119G(2) 039118G(2) 049119G(2) 0712119G(2) 0812118G(2) 0912118G(2) 1012119G(2) 1212118G(2) 200401
Recalling firm:
Oto Med Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2020

Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87577
Lot/product code:
UDI Code: 00850000126077 Lot Numbers: 019120 G(2) 0712119 G(2) 0912118 G(2) 1012119 G(2)
Recalling firm:
Oto Med Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2020

Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87577
Lot/product code:
UDI Code: 008500001260060 Lot Numbers: 019120G(2) 029119G(2) 039118G(2) 049119G(2) 0712119G(2) 0812118G(2) 0912118G(2) 1012119G(2) 1212118G(2) 200602
Recalling firm:
Oto Med Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 8, 2020

Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
86988
Lot/product code:
Lot numbers: 0010258435, 0010281390, 0010312360, 0010353505, 0010384900, 0010273889, 0010281391, 0010312361, 0010353507, 0010384901, 0010273890, 0010281392, 0010312362, 0010369366, 0010384903, 0010273891, 0010289835, 0010316959, 0010369367, 0010393220, 0010273893, 0010289836, 0010316960, 0010376784, 0010393221, 0010278418, 0010297678, 0010316961, 0010376785, 0010278427, 0010305929, 0010316963, 0010376786, 0010281384, 0010305937, 0010336620, 0010384897
Recalling firm:
Medtronic Neurosurgery
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 8, 2020

Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
86988
Lot/product code:
Lot Numbers: 0010038455, 0010258429, 0010289822, 0010316971, 0010376783, 0010061294, 0010258430, 0010289823, 0010316972, 0010384872, 0010061295, 0010258433, 0010297674, 0010316973, 0010384874, 0010083617, 0010265129, 0010297675, 0010336621, 0010384881, 0010083618, 0010265130, 0010297676, 0010336622, 0010384888, 0010083619, 0010265131, 0010297683, 0010336623, 0010393228, 0010083620, 0010265133, 0010305904, 0010353498, EB00006085, 0010083622, 0010265134, 0010305905, 0010353499, EB00006086, 0010083623, 0010265135, 0010305906, 0010369357, EB00006166, 0010097240, 0010278428, 0010305907, 0010369358, EB00007496, 0010097241, 0010278430, 0010305908, 0010369359, EB00007537, 0010097249, 0010281382, 0010305909, 0010376779, EB00009476, 0010097250, 0010281383, 0010316967, 0010376781, 0010097251, 0010289819, 0010316968, 0010376782
Recalling firm:
Medtronic Neurosurgery
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 8, 2020

Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
86988
Lot/product code:
Lot Numbers: 0010052549, 0010289829, 0010305920, 0010353501, 0010384893, 0010052552, 0010289830, 0010305921, 0010353502, 0010384894, 0010149011, 0010289831, 0010305923, 0010353503, 0010384895, 0010149013, 0010289833, 0010305926, 0010353504, 0010384896, 0010258434, 0010289834, 0010316955,, 0010369362, 0010393213, 0010265136, 0010297686, 0010316956, 0010369364, 0010393215, 0010265137, 0010297689, 0010316957, 0010369365, 0010393216, 0010265138, 0010297691, 0010316958, 0010376787, 0010393814, 0010278408, 0010297693, 0010336617, 0010376788, 0010393839, 0010278409, 0010297696, 0010336618, 0010376789, 0010289827, 0010305912, 0010336619, 0010376790, 0010289828, 0010305919, 0010353500, 0010384892
Recalling firm:
Medtronic Neurosurgery
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 8, 2020

Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
86981
Lot/product code:
Serial No. 1017-01 1017-04 1019-09 1019-09 1019-09 1020-01 1022-05 1022-05 1029-09 1029-09 1030-08 1030-09 1030-09 1030-10 1034-09 1036-07 1036-07 1138-03 1138-03 1138-04 1140-09 1140-10 1142-01 1142-02 1142-02 1142-04 1142-04 1142-05 1142-06 1142-08 1142-08 1142-08 1142-09 1142-09 1142-09 1142-10 1143-01 1143-06 1143-09 1143-09 1143-10 1144-01 1146-02 1147-01 1147-03 1147-04 1147-07 1147-09 1149-01 1150-04 1150-05 1150-06 1150-06 1150-06 1150-06 1150-06 1161-05 1161-06 1161-08 1161-08 1161-08 1161-08 1161-08 1163-07 1163-07 1163-07 1163-07 1163-07 1163-10 1163-10 1164-01 1167-06 1167-06 1167-06 1167-07 1167-07 1167-08 1167-08 1167-09 1167-09 1167-10 1167-10 1168-02 1168-02 1168-02 1168-03 1168-03 1168-03 1168-03 1168-03 1168-03 1168-03 1168-03 1168-04 1168-04 1171-01 1171-01 1171-01 1171-02 1171-05 1206-02 1206-03 1206-04 1206-05 1206-05 1206-06 1206-06 1206-06 1206-06 1206-07 1207-07 1207-08 1207-08 1207-08 1207-09 1207-09 1214-17 1214-18 1214-19 1214-19 1214-19 1214-19 1214-19 1214-20 1214-20 1214-20 1215-01 1215-01 1215-01 1215-17 1215-17 1215-17 1215-18 1215-20 1215-20 1215-20 1215-20 1216-18 1216-18 1325-01 1325-02 1325-03 1325-13 1325-13 1325-13 1325-14 1325-14 1325-14 1325-14 1325-14 1325-15 1325-16 1326-01 1326-01 1326-01 1326-02 1326-02 1326-02 1326-03 1326-03 1326-03 1326-04 1326-13 1326-14 1326-15 1326-16 1326-17 1326-17 1326-17 1326-18 1326-19 1326-19 1326-19 1326-20 1332-01 1332-01 1332-02 1332-02 1332-03 1332-06 1332-13 1332-14 1332-15 1332-16 1343-10 1344-01 1344-02 1344-03 1344-04 1344-05 1344-05 1344-05 1344-05 1344-06 1344-07 1344-08 1344-09 1344-09 1344-09 1344-10 1344-10 1344-10 1345-01 1345-03 1345-04 1345-05 1345-05 1350-06 1350-06 1350-07 1350-08 1351-02 1353-01 1353-02 1353-03 1353-03 1353-04 1353-04 1360-02 1360-02 1360-02 1360-03 1360-03 1360-03 1360-04 1361-05 1361-06 1361-06 1361-06 1361-09 1361-09 1361-10 1361-10 1362-01 1362-02 1362-03 1362-04 1362-04 1362-04 1362-04 1362-04 1362-05 1362-05 1364-02 1364-03 1364-04 1364-05 1364-06 1364-07 1364-08 1364-08 1366-01 1366-01 1366-01 1366-02 1366-02 1366-02 1366-04 1366-05 1366-06 1366-07 1366-08 1372-01 1372-01 1372-02 1372-06 1475-08 1475-08 1475-09 1475-10 1475-10 1485-07 1485-08 1485-09 1487-06 1487-07 1487-07 1488-02 1488-07 1492-06 1492-06 1492-06 1492-06 1492-06 1492-07 1492-08 1492-08 1492-08 1492-08 1492-08 1497-01 1497-02 1497-03 1497-03 1497-04 1497-04 1497-05 1497-06 1497-07 1497-08 1497-08 1497-08 1497-08 1497-08 1497-08 1497-08 1498-01 14A1-10 14A2-05 14A2-05 14A2-06 14A2-07 14A2-07 14A2-08 14C2-03 14C4-06 14C6-01 14C6-02 14C6-02 14C6-03 14C9-06 14C9-09 14C9-10 14C9-10 14D1-09 14D1-10 14D2-01 14D2-02 14D2-03 14D3-07 14D3-08 14D4-02 14D4-09 14D4-10 14D5-01 14D5-02 14D5-10 14D6-01 14D6-02 14D6-03 15F3-04 15F3-04 15F3-05 15F3-05 15F3-06 15F3-07 15F3-07 15F3-08 15F3-08 15F3-09 15F3-09 15G6-09 15G6-09 15G6-10 15G6-10 15G7-01 15H4-01 15H4-01 15H4-02 15H4-02 15H4-03 15H4-05 15H4-06 15H4-06 15H4-08 15H4-08 15H4-09 15H4-10 15H5-01 15H5-02 15H5-04 15H5-05 15H5-06 15H6-06 15K9-08 15K9-09 15L0-02 15L9-09 15M6-07 15M6-09 15M6-10 15M7-01 15M7-02 15M7-03 15M7-03 15M7-04 15M7-04 15M7-05 15M7-05 15M7-06 15M7-06 15M9-03 15M9-04 15M9-07 15P0-02 15P2-08 15P5-03 15P5-03 15P5-04 15P5-04 15P6-03 15P6-03 15P8-09 15P8-10 15P9-01 15P9-01 15P9-02 15P9-02 15P9-03 15P9-05 15P9-06 15P9-07 15P9-07 15P9-08 15R8-01 15R8-01 15R8-04 15R8-04 15R8-05 15R8-06 15R8-07 15R8-10 15R8-10 15R9-01 15R9-02 15R9-03 15R9-04 15R9-05 15R9-06 15S3-03 15S3-04 15S3-08 15S3-10 1638-09 1639-01 1639-02 1639-03 1639-06 1639-07 1639-08 1639-09 1639-10 1640-01 1645-03 1647-09 1647-10 1647-10 1648-01 1648-01 1648-02 1648-03 1648-04 1648-05 1648-06 1648-07 1655-06 1655-07 1656-01 1656-02 16S8-03 16S8-04 16S8-05 16S8-07 16S8-08 16S8-09 16S9-01 16S9-02 16S9-02 16S9-03 16S9-03 16S9-04 16S9-05 16S9-08 16S9-08 16U1-05 16U1-09 16U1-10 16U2-01 16U2-02 16U2-03 16U2-04 16U2-09 16U2-10 16U5-02 16U5-03 16U5-04 16U5-10 16U6-01 16U6-01 16U6-02 16U6-02 16U6-03 16U6-05 16U6-06 16U6-07 16V9-03 16W0-06 16W0-07 16W0-08 16W0-09 16W4-07 16X4-07 16X4-08 16X4-09 16X4-10 16X5-01 16X5-02 16X5-03 16X5-04 16X5-05 16X5-06 16X5-07 16X5-08 16X5-09 16Y3-04 16Y3-05 16Y3-06 16Y3-07 16Y3-09 16Y3-10 16Y4-01 16Y4-01 16Y4-02 16Y4-02 16Y4-03 16Y4-03 16Y5-09 16Y5-10 16Y6-01 16Y6-02 16Y6-04 16Y6-05 16Y6-06 16Y6-10 16Y8-04 16Y8-05 16Y8-09 16Y8-09 16Y8-10 16Y9-01 16Y9-07 16Z2-01 16Z2-02 16Z2-03 16Z2-05 16Z2-06 16Z2-07 16Z2-08 16Z2-09 16Z8-05 1775-09 1779-02 1779-02 1779-03 1779-04 1779-05 1779-06 1779-07 1779-08 1795-01 1795-02 1795-03 1795-04 1795-05 1795-06 1795-07 1795-08 1795-10 1796-01 17A8-07 17A8-08 17A9-02 17A9-02 17B5-02 17B5-03 17B5-05 17B5-05 17B5-06 17B5-09 17B6-02 17D4-05 17D5-01 17D5-02 17D5-04 17D5-04 17D5-04 17D5-05 17D5-05 17D6-03 17D6-03 17D6-04 17D6-05 17D6-06 17D6-07 17D6-08 17D6-09 17E1-05 17E1-06 17E1-08 17E4-04 17E4-04 17E4-05 17E4-06 17E4-07 17E4-08 17E4-09 17E4-10 17F6-09 17F6-09 17F6-10 17F7-01 17F7-02 17F7-03 17G1-05 17G1-07 17G3-05 17G3-06 17G3-07 17G3-09 17G3-09 17G5-08 17G5-09 17G5-10 17G6-… (truncated, 8410 characters total — see the official FDA record for the full value)
Recalling firm:
Roche Diagnostics Operations, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 8, 2020

Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities.

System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87322
Lot/product code:
Table CAT-880B Models: INFX-8000C/B6 INFX-8000C/B6 INFX-8000C/B4UP INFX-8000C/B4 INFX-8000C/UP INFX-8000C/UE INFX-8000C/U5 INFX-8000C/B4 INFX-8000C/A6 INFX-8000C/B6 INFX-8000C/A6 INFX-8000C/A6 INFX-8000C/A6 INFX-8000C/UP INFX-8000C/A6 INFX-8000C/UP INFX-8000C/AF INFX-8000C/A6 INFX-8000C/BF INFX-8000C/A4 INFX-8000C/UE INFX-8000C/A2 INFX-8000C/A6 INFX-8000C/UP INFX-8000C/A6 INFX-8000C/UE INFX-8000C/UE INFX-8000C/UC INFX-8000C/AF INFX-8000C/AF INFX-8000C/A6 INFX-8000C/A6 INFX-8000C/AF/VL72-2015B INFX-8000C/AF INFX-8000C/BF INFX-8000C/B2 INFX-8000C/BF INFX-8000C/B4 INFX-8000C/BF INFX-8000C/BF INFX-8000C/BF INFX-8000C/BF INFX-8000C/A6 INFX-8000C/A4 INFX-8000C/BF  Table Serial Number: B1C2072072 B1C2072070 B1C2032061 B1B19Z2048 99A1332131 99B1352138 99A1292103 B1B19X2040 99F1872415 B1A1942012 99E16X2327 99F1872409 99E1542247 99B1372146 99C1472196 99B1352139 99F1832396 99E1582259 B1A1932005 99C1472199 99A1312122 99F1812388 99F1872414 99B1342135 99E1682315 99B1342133 99B1342134 99A1332130 99F1872413 99f1872411 99F1852400 99E1742355 99E1662307 99F1892424 CTC18Y2004 B1B1972026 B1B1972029 B1B19Z2046 B1C2062066 B1A1952017 B1B1972025 B1A1942009 99C1492202 99C13Z2171 B1C2012051  System Serial Numbers: B6C2072003 B6C2072002 B4C2032004 B4B19Z2003 UPA1332003 UEB1352004 U5C1292001 B4B19X2001 A6C1872011 B6B1942001 A6B16X2006 A6C1872009 A6B1532003 UPB1372006 U6A1472001 UPB1352005 AFB1832003 A6B1582004 BFA1932001 A4B1472002 UEA1312001 A2C1812002 A6C1872010 UPB1342004 A6B1682005 UEB1347001 UEB1347002 UCA1022004 AFB1872005 AFB1872004 A6C1852008 A6B1742007 AFA1662001 AFB1892006 BFA18Y7001 B2B1972001 BFB1972005 B4B19Z2002 BFC2062007 BFB1952003 BFB1972004 BFB1942002 A6A1492002 A4A13Z2001 TEMPPM007995
Recalling firm:
Canon Medical System, USA, INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 8, 2020

Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discrete), for clinical use Part Number: 05641446001

Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
86981
Lot/product code:
Serial Numbers: 1925-10; 1931-04; 1931-05;1931-07;1937-10; 1938-01; 1942-10
Recalling firm:
Roche Diagnostics Operations, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 8, 2020

Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities.

System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87322
Lot/product code:
Table CAT-880B Models: INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/BHUP INFX-8000F/AH INFX-8000F/AH INFX-8000F/UU INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/BH  Table Serial Numbers: 99E1582258 99F18Y2428 99C1482200 99E15Y2271 99F1862406 99G19Z2438 99E1662308 99E1762365 99A1337005 99F1852401 99E1612286 99E1712347 99E1712345 99C14Z2224 99E1592262 99G1972436  System Serial Numbers: AHA1582003 AHC18Y2013 AHA1482001 AHA15Y2005 AHC1862012 BHB19Z2002 AHB1662007 AHB1762010 UUB12X2034 AHC1852011 AHA1612006 AHB1712009 AHB1712008 AHA14Z2002 AHA1592004 BHB1972001
Recalling firm:
Canon Medical System, USA, INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 8, 2020

Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities.

System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87322
Lot/product code:
Table CAT-880B Models: INFX-8000V/A6 INFX-8000V/AA INFX-8000V/AC INFX-8000V/A8 INFX-8000V/U7 INFX-8000V/AA INFX-8000V/U7 INFX-8000V/UF INFX-8000V/BN INFX-8000V/BU INFX-8000V/UD INFX-8000V/UL INFX-8000V/A6 INFX-8000V/AC INFX-8000V/AA INFX-8000V/UU INFX-8000V/A6 INFX-8000V/U5 INFX-8000V/BAUP INFX-8000V/A2 INFX-8000V/A2 INFX-8000V/A4 INFX-8000V/UL INFX-8000V/UL INFX-8000V/UL INFX-8000V/A4 INFX-8000V/BG INFX-8000V/BG INFX-8000V/A6 INFX-8000V/AA INFX-8000V/AA INFX-8000V/AA INFX-8000V/AA INFX-8000V/BQ INFX-8000V/UU INFX-8000V/BL INFX-8000V/BL INFX-8000V/A6 INFX-8000V/A6 INFX-8000V/AC INFX-8000V/BL INFX-8000V/UF INFX-8000V/UF INFX-8000V/BY INFX-8000V/BS INFX-8000V/A6 INFX-8000V/AA INFX-8000V/AC INFX-8000V/UF INFX-8000V/UF INFX-8000V/B6 INFX-8000V/UF INFX-8000V/A6 INFX-8000V/A6 INFX-8000V/A6 INFX-8000V/U7 INFX-8000V/UU INFX-8000V/UD INFX-8000V/BC INFX-8000V/UU INFX-8000V/BG INFX-8000V/A6 INFX-8000V/A6 INFX-8000V/A4 INFX-8000V/UL INFX-8000V/A8/VL63-2015B/A INFX-8000V/AA INFX-8000V/A8 INFX-8000V/A4 INFX-8000V/BY INFX-8000V/BY INFX-8000V/UF INFX-8000V/AA INFX-8000V/A8 INFX-8000V/A4 INFX-8000V/AA INFX-8000V/A6 INFX-8000V/B2 INFX-8000V/BU INFX-8000V/UU INFX-8000V/A6 INFX-8000V/A6 INFX-8000V/A6 INFX-8000V/UU INFX-8000V/BQ  Table Serial Numbers: 99E15X2267 99E1692317 99C1472192 99E16Y2329 99A12X2107 99E1542248 99C1462190 99C1442183 B1B19Y2043 B1A1942008 99A1292104 99A1322127 99E15Y2275 99C1492204 99C1492205 99A12Z2117 99E1742358 99A1272094 B1C2012053 99F18X2427 99F1952435 99D1522239 99A12Z2118 99C1392151 99C1452189 99F1862408 B1B1962022 B1B1962021 99E1652304 99F1862407 99E17X2373 99E17X2374 99E17X2375 B1B1962023 99A12X2108 B1C2022054 B1B1992039 99E16X2328 99E1622292 99E16Y2338 B1A1952015 99A12X2109 99C1452184 B1B1992038 B1C2052064 99C14Z2230 99F1882417 99E1622293 99C13X2156 99C13X2155 B1C2072071 99B1362141 99F1862403 99H2032441 99E17Z2380 99A1322125 99C13Z2167 99A1322123 B1B19X2041 99A12X2106 B1C2072073 99E16Y2336 99E1612287 99C14X2207 99C1452185 99E17Z2382 99F1842398 99E1532243 99C14Z2232 B1A1932006 B1A1932004 99A12Z2116 99E1712346 99E17X2372 99C1512236 99C14X2206 99E1582261 B1B1962020 B1B1982033 99C1452186 99F1862402 99F1862405 99E16Z2340 99A1312120 B1C2082075  System Serial Numbers: A6A15X2003 AAA1692006 ACA1472001 A8B16Y2002 U7D12X2007 A9A1542001 U7E1462009 UFD1442017 BNB19Y2001 BUB1942001 UDA0952001 ULC1322012 A6A15Y2004 ACA1492002 AAA1492001 UUB12Z2009 A6B1742011 U5E1272003 BAD2012001 A2C18X2001 A2C1952002 A4A1522004 ULC1282010 ULD1392013 ULD1452016 A4B1862007 BGB1962002 BGB1962001 A6B1652007 AAB1862012 AAA17X2008 AAA17X2009 AAA17X2010 BQB1962001 UUB12X2008 BLD2022003 BLB1992002 A6B16X2008 A6B1622006 ACB16Y2004 BLB1952001 UFC12X2011 UFD1452018 BYB1992003 BSD2052001 A6A14Z2001 AAB1882013 ACB1622003 UFD13X2016 UFD13X2015 B6D2072001 UFD1362014 A6C1862014 A6C2032016 A6B17Z2012 U7D1322008 UUC13Z2011 UDD1322016 BCB19X2001 UUB12X2007 BGD2072003 A6B16Y2009 A6A1612005 A4A14X2001 ULD1452015 A8B17Z2004 AAB1842011 A8A1532001 A4A14Z2002 BYA1932002 BYA1932001 UFC12Z2013 AAA1712007 A8B17X2003 A4A1512003 AAA14X2002 A6A1582002 B2B1962001 BUB1982002 UUC1452012 A6C1862013 A6C1862015 A6B16Z2010 UUB1312010 BQD2082002
Recalling firm:
Canon Medical System, USA, INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 10, 2020

Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100XF) - Product Usage: intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality.

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87023
Lot/product code:
Discovery 670 DR (Model H3100BT), Serial Numbers: DRGY56033, DRGY56037, DRGY56035, DRGY56030, DRGZ56043, DRGZ56042, DRGY56032, DRGY56031, DRGY56034, DRGY56036    NM/CT 870 DR (Model 3100Q), Serial Numbers: 870Y64066, and (Model H3100AS), Serial Numbers: 870Y64077, 870Y64064, 870Y64081, 870Y64079, 870Y64067, 870Y64074, 870Z64117, 870Y64078, 870Y64080, 870Y64069, 870Y64085, 870Z64121, 870Z64119, 870Z64122, 870Y64056, 870Y64063, 870Z64114, 870Z64115, 870Y64068, 870Y64082, 870Z64116, 870Z64120, 870Y64065, 870Y64084, 870Y64061, 870Y64083, 870Z64113, 870Y64070, 870Z64123, 870Y64058, 870Z64118, 870Y64057   Discovery NM670 Pro (Model 3100XB), Serial Numbers: PRGY52027,  PRGY52031, PRGZ52047, PRGZ52046, PRGY52028, PRGZ52048, PRGY52029, PRGY52030    Discovery 670 ES (Model H3100XF), Serial Numbers: ESGZ53005
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 10, 2020

Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87023
Lot/product code:
Serial Numbers: 64GY51017, 64GY51020, 64GY51022, 64GZ51028, 64GZ51030, 64GZ51029, 64GY51021
Recalling firm:
GE Healthcare, LLC
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UnclassifiedRisk not yet known
Medical deviceRecalled December 10, 2020

GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

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FDA has not published a risk classification for this recall yet.

Recall #:
87023
Lot/product code:
Serial numbers: 87CY63028, 87CZ63044, 87CZ63045, 87CZ63042, 87CY63025, 87CY63029, 87CY63027, 87CY63030, 87CZ63046, 87CY63034, 87CY63032, 87CY63033
Recalling firm:
GE Healthcare, LLC
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UnclassifiedRisk not yet known
Medical deviceRecalled December 10, 2020

Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

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FDA has not published a risk classification for this recall yet.

Recall #:
87023
Lot/product code:
Discovery NM 630 (Model Number H3101RH), Serial numbers: 63GY50110,  63GY50119, 63GY50116, 63GZ50141, 63GY50120, 63GY50108, 63GY50121, 63GZ50142, 63GY50112, 63GZ50139, 63GY50107, 63GZ50138   NM 830 (Model Number H3910AC), Serial Numbers: 830Z60199, 830Z60182, 830Z60183, 830Z60192, 830Y60089, 830Y60105, 830Y60079, 830Z60207, 830Y60092, 830Y60102, 830Y60081, 830Z60200, 830Y60106, 830Z60201, 83EZ88001, 830Y60111, 830Y60094, 830Z60211, 830Y60101, 830Z60210, 830Y60118, 830Z60195, 830Z60194, 830Z60198, 830Z60181, 830Z60202, 830Y60097, 830Z60196, 830Z60180, 830Y60078, 830Y60115, 830Y60114, 830Y60108, 830Y60100, 830Y60087, 830Y60084, 830Z60188, 830Z60206, 830Y60112, 830Y60082, 830Y60093, 830Z60191, 830Y60107, 830Y60080, 830Z60190, 830Y60103, 830Z60193, 830Y60095, 830Y60119, 830Z60209, 830Z60205, 830Y60073, 830Y60120, 830Y60083, 830Y60116, 830Z60203, 830Y60085, 830Y60077, 830Z60184, 830Y60086, 830Z60187, 830Y60113, 830Z60208, 830Y60110, 830Z60204, 830Y60072, 830Z60179, 830Z60186   830 NM Cyber Defense (Model Number H3910AG), Serial Numbers: 830Z60185
Recalling firm:
GE Healthcare, LLC
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UnclassifiedRisk not yet known
Medical deviceRecalled December 10, 2020

GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

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FDA has not published a risk classification for this recall yet.

Recall #:
87023
Lot/product code:
Serial numbers: 85EY67048, 850Y61018, 85EY67045, 85EY67046, 85EY67047, 850Z61038, 85EY67043, 850Z61042, 85EZ67056, 850Z61043,  850Z61044, 850Z61045, 850Z61041, 850Z61039, 850Z61040, 85EZ67055, 85EZ67053, 85EZ67054, 850Y61019, 85EY67044, 85EY67049, 85EZ67052, 85EY67050, 85EZ67051
Recalling firm:
GE Healthcare, LLC
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UnclassifiedRisk not yet known
Medical deviceRecalled December 10, 2020

GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

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FDA has not published a risk classification for this recall yet.

Recall #:
87023
Lot/product code:
Serial numbers: 860Y62016, 860Y62019, 860Y62017, 860Z62032, 860Y62018, 860Y62015, 860Y62012, 860Y62020, 860Y62021, 860Y62013,  860Z62033, 860Z62031
Recalling firm:
GE Healthcare, LLC
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UnclassifiedRisk not yet known
Medical deviceRecalled December 11, 2020

VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 Slide cartridge) Product Code: 8001133 Quantitatively measure creatine kinase MB (CK-MB) activity in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.

VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference

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FDA has not published a risk classification for this recall yet.

Recall #:
87028
Lot/product code:
INITIAL Communication: 11 December 2020, (Communication Ref. # CL2020-302) Coatings 0230, 0231, 0233, 0235, 0239 (all lot numbers) Extended Recalls: Recall Extension #1, for VITROS CKMB Slides, Coating 0245 (Communication Reference, CL2021-182) 18 June 2021 Recall Extension #2 for VITROS CKMB Slides, Coating 0246 (Communication Reference, CL2021-214) 18 August 2021 Recall Extension #3 for VITROS CKMB Slides, Coating 0248 (Communication Reference, CL2021-274) , 1 November 2021 Recall Extension #4 for VITROS CKMB Slides, Coating 0261 (Communication Reference, CL2023-244) , 27 October 2023 UDI: (1) (10758750004294) (2) (10758750004201
Recalling firm:
Ortho Clinical Diagnostics Inc
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