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Recalls affecting Wyoming

Data last updated: September 11, 2026 at 1:08 PM UTC

16,303 recalls found

Just announced

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

Business Pill, Branch Manager for Mendietary 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 AliveMoringa 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. Braun0.9% 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 ValueOrganic 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 TemptationsChocolatey 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

LipofitLipofit 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

KofinasGarlic 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 SproutsRobust 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

MartinaMangoes

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 February 23, 2022

Artis Q ceiling, Model Number 10848281

If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".

ALL 50 STATES
Full report

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

Recall #:
89860
Lot/product code:
UDI: 4056869009988; Serial Numbers: 109130 109490 109552 110088 110059 110103 133503 109799 110035 109642 109892 109135 109569 109123 110046 109400 110005 109812 109727 109210 109628 110058 109931 110056 109080 109610 110062 109074 109746 109417 109479 109352 109388 109190 109191 109197 109198 109418 109419 109421 133000 133201 109305 109789 109792 109889 109592 109738 109405 109657 109119 109346 109016 109523 109645 109118 109693 109493 110067 109583 109817 109460 109137 109512 109155 109379 109681 109820 109709 110119 109187 109663 109787 109747 109228 109327 109412 109066 109067 109068 109760 110095 109084 109133 109134 110051 109833 109365 109217 109366 110001 110020 109688 109203 109367 110007 109169 109434 109589 109838 110093 109769 109660 109651 133202 110109 110128 109378 109384 109639 109598 109893 109783 110096 109621 109653 109500 109602 109748 109451 109504 109505 109143 109526 109565 109102 109431 109383 109785 109794 109407 109015 109029 109136 109442 110069 110106 109194 109132 109662 109144 109726 109413 109674 109803 109627 109772 109482 109780 110063 110042 110043 110048 110064 110032 110047 110102 109536 110039 110040 109656 109309 109779 110023 109700 110014 110110 109488 110065 133001 109848 109168 109227 109520 109467 110052 109057 109221 109484 109830 109915 109501 110018 109162 109507 109567 109103 109165 109038 109604 109040 109324 109603 110072 109741 109034 109129 109673 109668 109181 109884 109643 109620 109064 109009 109678 109219 109321 109541 110081 110036 109330 109629 109452 109076 109749 109435 109551 109652 109386 110054 109795 109179 109007 109661 109699 109613 109716 109458 109777 109229 109538 109752 109357 109659 109424 110053 109531 110107 109532 109071 109072 109075 110044 109231 109355 109543 109503 109091 110031 109300 109591 109630 109090 109631 109393 109920 109311 110016 109041 109856 109886 110037 110077 109497 109164 109167 109039 109908 109771 110079 109527 109362 109060 109762 109839 109842 109845 110099 109922 109429 109644 110113 109717 109560 109599 110027 109564 109813 110049 110117 110066 110024 109088 109807 109809 109814 110017 109736 109397 110025 109685 109096 109159 109358 109542 109558 109715 109638 109364 110100 110129 109624 109773 109463 109415 109021 109524 110083 110091 109171 109048 109172 109525 109742 109301 109020 109043 109326 109601 110006 109793 109827 109818 109336 110115 109815 109718 109664 109163 109101 109104 109105 109107 109302 109369 109361 109232 109759 110055 109829 109844 109854 109186 109371 109722 109069 109648 109670 109671 109158 110026 109047 109801 110022 109031 109027 109028 109318 109120 109402 109921 109862 109866 109871 110000 109010 109677 109705 109756 109757 133501 109156 109157 109307 109411 109770 109563 109739 109349 109456 110057 109606 109391 109774 109214 109683 109863 110104 109044 110041 109917 109641 109697 Additional Serial Numbers as of 10/4/23: 133504 109145 109211 109350 109461 103053 103040 109308 109416 109457 109225 109222 109224 109320
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 23, 2022

Artis zee biplane, Model Number 10094141

If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".

ALL 50 STATES
Full report

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

Recall #:
89860
Lot/product code:
UDI: 4056869010069; Serial Numbers: 153131 153229 154827 155168 154408 153172 153315 153317 153992 154157 154616 155122 155149 153717 154551 153779 153280 153648 155265 153166 154536 154767 154454 155190 154715 153834 154789 154779 153169 154532 153803 131022 153110 131209 153199 154721 154722 153887 154571 154074 154012 155323 153191 153252 154612 153274 153239 153227 153889 154090 153285 153234 153236 154658 154847 154686 153273 153344 154095 153342 154567 154093 154502 153171 153197 153916 153831 131110 153883 153256 154704 153154 154086 153139 131707 153882 155189 153311 153211 154727 155151 153987 155266 155237 153740 131107 155105 153863 153772 154509 154079 153965 154462 153707 154480 155296 154794 154073 153263 153276 154076 153758 155148 131013 131219 153257 154792 155279 154156 156014 153112 153155 155193 153245 154799 153318 153720 153998 153271 153857 153226 153939 153951 154814 156011 153290 153678 153679 153277 154783 131221 153125 153128 153135 153743 153967 154731 153946 153145 154801 154683 153829 153148 131021 153878 153906 153959 131208 131104 153709 153119 153217 154565 154653 154671 154556 154406 154518 155126 153164 153304 154778 153869 153634 154685 153719 153232 131101 131005 153770 154633 154020 153930 153355 154058 153811 154684 153225 154155 153875 155203 153289 153790 153102 154708 153963 154579 154762 153824 154034 154018 153356 154560 155131 155191 154596 153701 153113 153235 153347 153708 153338 154066 131223 153706 153259 154663 153314 154544 155291 153988 154614 154048 155310 155132 154800 153716 154592 131261 131224 153922 154014 153870 153628 155195 153249 153860 153264 155312 155119 153157 153903 153908 153819 154087 131247 153914 154085 154471 154604 154606 155286 154687 131111 153156 154707 154877 154459 153697 131000 154581 153147 154546 153928 155121 153864 153159 153756 154052 153797 154028 154732 154709 155226 155227 154678 131108 153865 153640 153714 153736 153832 153913 131011 153348 155159 153220 153947 131106 131103 153657 153873 154430 153117 153299 131213 153109 153150 154501 154514 153898 153757 154859 154064 155343 154562 154585 154044 153111 153618 153689 153847 154770 154056 153999 154785 153732 153728 153682 153120 153122 155118 153763 153686 154100 153631 154082 153617 153327 154429 153180 153818 154007 153323 154055 154631 153694 153886 154576 153186 154067 131020 155235 131262 154584 153270 154610 153862 131260 153607 153760 153265 153332 153343 153975 154476 153993 153325 153251 153254 131231 155150 154739 153684 153799 154041 155147 153952 153206 154602 154097 131252 153115 154572 131235 154564 154884 153744 153827 153671 Additional Serial Numbers as of 10/4/23: 154453 154094 131006
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 23, 2022

Artis zee biplane MN, Model Number 10094143

If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".

ALL 50 STATES
Full report

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

Recall #:
89860
Lot/product code:
UDI: 4056869010106; Serial Numbers: 149100 149401 149421 149106 149202 149420 149402
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 23, 2022

Artis Q.zen biplane, Model Number 10848355

If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".

ALL 50 STATES
Full report

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

Recall #:
89860
Lot/product code:
UDI: 4056869010038; Serial Numbers: 123225 123245 123026 123043 123031 123053 123202 123050 123248 123008 123255 123252 123259 123035 123211 123247 123011 123003 123032 123208 123209 123231 123246 123254 123025 123036 123220 123221 123222 123206 123207 123268 123240 123262 123265 123219 123505 123213 123250 123251 123022 123229 123205 123502 123201 123023 123024 123224 123232 123233 123234 123501 123027 123049 123249 123055 123056 123037 123264 123010 123046 123052 123200 123015 123016 123244 123212 Additional Serial Numbers as of 10/4/23: 123216 123239
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 23, 2022

Artis Q.zen floor, Model Number 10848353

If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".

ALL 50 STATES
Full report

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

Recall #:
89860
Lot/product code:
UDI: 4056869010014; Serial Numbers: 105120 105110 105033 105032 105500 105105 105028 105503 105018 105114 105115 105026 105025 105135 105016 105119 105137 105501 105132 105128 105142 105017 105121 105122 105123 105100 105112 105124 105029 105030 105031 105125 Additional Serial Numbers as of 10/4/23: 143500
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 23, 2022

Artis Q.zen ceiling, Model Number 10848354

If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".

ALL 50 STATES
Full report

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

Recall #:
89860
Lot/product code:
UDI: 4056869010021; Serial Numbers: 111160 111162 111163 111137 111502 111139 111174 111185 111503 111005 111002 111145 111176 111510 111155 111179 111140 111507 111122 111168 111170 111173 111512 111141 111508 111521 111133 111003 111111 111103 111101 111011 111182 111184 111143 111150 111164 111183 111504 111149 111109 111151 111129 111121 111130 111517 111513 111017 111010 111115 111116 111117 111119 111104 111148 111127 111175 111506 111112 111131 111132 111134 111158 111167 111157 111161 111142 111156 111500 111501 111169 111505 111166 111107 111514 111000 111106 111123 111128 111135 Additional Serial Numbers as of 10/4/23: 111125
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 24, 2022

SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum.

Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the hydrogel following implantation, as well as technique recommendations for the proper placement of SpaceOAR and SpaceOAR Vue.

ALL 50 STATES
Full report

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

Recall #:
89862
Lot/product code:
UPN SO-1010, GTIN 00864661000157, Batch Numbers: 25512955, 25512956, 25608548, 25646105, 25652246, 25676663, 25676664, 25681783, 25814685, 25814686, 25814687, 25822800, 25822812, 25822814, 25822815, 25822818, 25846481, 26059500, 26199152, 26199153, 26199154, 26199155, 26223961, 26223962, 26223963, 26223964, 26223965, 26249663, 26296567, 26296568, 26330692, 26330693, 26330694, 26330695, 26360535, 26360536, 26392679, 26450673, 26450674, 26450675, 26479093, 26514195, 26514196, 26514197, 26514198, 26552142, 26552143, 26552144, 26552145, 26552146, 26552147, 26552148, 26552149, 26552150, 26559675, 26582245, 26582246, 26582247, 26582248, 26604083, 26604084, 26604085, 26620165, 26620166, 26747082, 26747083, 26747084, 26810389, 26810390, 26840623, 26840624, 26891606, 26891607, 26942179, 26943300, 26962856, 26962857, 27092550, 27092551, 27092552, 27123363, 27164903, 27164904, 27208217, 27224418, 27251110, 27251111, 27290123, 27290124, 27290125, 27290126, 27705892, 27705893, 27777685, 27777686, 27818531, 27818831, 27860308, 28189378, 28221394, 28221395, 28221396, 28221397, 28398571, 28398572, 28413030, 28535614;  UPN SO-2101, GTIN 00864661000102, Batch Numbers: 25447885, 25449325, 25454386, 25454387, 25461459, 25495940, 25498279, 25498740, 25498741, 25498742, 25503112, 25503113, 25503114, 25503115, 25503116, 25506791, 25513909, 25513910, 25513911, 25513912, 25516002, 25516004, 25518766, 25518767, 25518769, 25518770, 25604214, 25604215, 25608549, 25630371, 25630372, 25630373, 25633109, 25638880, 25638881, 25638882, 25638883, 25640316, 25640317, 25646106, 25650375, 25650376, 25652248, 25652249, 25652250, 25660251, 25660252, 25661506, 25665261, 25665262, 25665263, 25681784, 25686490, 25686491, 25692043, 25698959, 25699200, 25699201, 25699202, 25706244, 25706245, 25707436, 25707437, 25712686, 25712687, 25712688, 25712689, 25720694, 25720695, 25720696, 25725090, 25743052, 25743053, 25743054, 25746319, 25746420, 25746421, 25746422, 25746423, 25748984, 25748985, 25748986, 25748987, 25752521, 25752522, 25752523, 25752524, 25773305, 25773306, 25775424, 25775425, 25780322, 25780323, 25829631, 25829632, 25829633, 25829634, 25829635, 25838013, 25838014, 25846482, 25846483, 25846484, 25846485, 25852659, 25852880, 25852881, 25852882, 25852883, 25861746, 25861747, 25876396, 25876397, 25876398, 25876399, 25876840, 25876841, 25878667, 25878668, 25878669, 25883155, 25883156, 25883157, 25883158, 25883159, 25889579, 25890040, 25890041, 25890042, 25891035, 25907181, 25907182, 25909720, 25909721, 25909722, 25909723, 25916278, 25916279, 25916440, 25916441, 25916442, 25916443, 25921966, 25921967, 25921968, 25921969, 25921970, 25934785, 25934786, 25934787, 25934788, 25934789, 25945186, 25945187, 25945188, 25945189, 25952097, 25952098, 25952099, 25963297, 25963298, 25963299, 25963440, 25970532, 25970533, 25988372, 25988373, 25988374, 25988375, 25997188, 26005315, 26005316, 26005317, 26005318, 26014544, 26014545, 26014546, 26028461, 26028462, 26028463, 26028464, 26028465, 26035128, 26035129, 26042542, 26042543, 26042544, 26042545, 26042546, 26042547, 26042548, 26058237, 26058238, 26058239, 26059080, 26059081, 26059501, 26060392, 26071663, 26071664, 26071671, 26071672, 26071673, 26071674, 26075962, 26075997, 26078689, 26078690, 26078691, 26078692, 26078693, 26088832, 26088833, 26088834, 26088835, 26088836, 26106496, 26106497, 26106498, 26106499, 26107243, 26107244, 26107245, 26107246, 26107247, 26111500, 26111501, 26111502, 26111503, 26111504, 26111505, 26121817, 26121818, 26121819, 26122100, 26128620, 26128621, 26128622, 26128623, 26137216, 26137217, 26170536, 26170537, 26172513, 26172514, 26172515, 26172516, 26172517, 26177019, 26177460, 26177461, 26178897, 26178898, 26184397, 26184398, 26184399, 26184580, 26184581, 26186561, 26186562, 26186563, 26186564, 26186565, 26187164, 26187165, 26191446, 26191447, 26191448, 26191449, 26191450, 26193736, 26193737, 26193738, 26209535, 26209536, 26209537, 26209538, 26212441, 26212442, 26212443, 26212444, 26216386, 26216387, 26216388, 26216389, 26216390, 26219745, 26219746, 26223179, 26223960, 26240334, 26240335, 26240336, 26240337, 26248777, 26248778, 26248779, 26248900, 26249466, 26249467, 26255000, 26255001, 26255002, 26255003, 26255004, 26257955, 26257956, 26257957, 26257958, 26264347, 26264348, 26264349, 26264350, 26264351, 26264352, 26268603, 26276556, 26276558, 26276559, 26287765, 26287766, 26287767, 26294565, 26301543, 26301544, 26301545, 26301546, 26302983, 26302984, 26308362, 26308363, 26308364, 26308365, 26308366, 26309943, 26316226, 26316227, 26316228, 26316229, 26325606, 26325607, 26360529, 26360530, 26360531, 26360532, 26390962, 26390963, 26390964, 26390965, 26390966, 26390967, 26479092, 26514199, 26514580, 26588906, 26588907, 26588908, 26588909, 26604086, 26604087, 26620161, 26620162, 26634757, 26634758, 26660269, 26736692, 26736693, 26736694, 26736695, 26736696, 26736697, 26747085, 26747086, 26754536, 26754537, 26774348, 26774349, 26774350, 26774351, 26774352, 26779764, 26780807, 26780808, 2… (truncated, 11138 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 February 24, 2022

SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum.

Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the hydrogel following implantation, as well as technique recommendations for the proper placement of SpaceOAR and SpaceOAR Vue.

ALL 50 STATES
Full report

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

Recall #:
89862
Lot/product code:
UPN SV-1010, GTIN 00850009803009, Batch Numbers: 26383209, 26383210, 26517604, 26861584, 26861585, 26891612, 26891613, 27083784, 27190242, 27210560, 27257801, 27257802, 27455966, 27455967, 27496959, 27497140, 27670956, 27708041, 27708042, 27708043, 27930863, 27930864, 27941129, 27941130, 27949315, 28094077, 28247077, 28247078, 28358778, 28377018, 28377019, 28464794, 28464795, 28496461, 28496462, 28578758, 28578759, 28608231, 28608232;  UPN SV-2101, GTIN 00864661000140, Batch Numbers: 26345481, 26376961, 26376962, 26376963, 26376964, 26380456, 26380457, 26384055, 26384056, 26408849, 26485974, 26485975, 26485977, 26486586, 26486587, 26486588, 26493461, 26517606, 26517607, 26529719, 26567283, 26567284, 26567285, 26567286, 26567287, 26574373, 26574374, 26574378, 26574379, 26574441, 26611593, 26611594, 26611595, 26652286, 26652287, 26691824, 26691826, 26691827, 26691828, 26705563, 26705564, 26705565, 26705566, 26728564, 26728565, 26743769, 26743770, 26743771, 26743772, 26745057, 26770161, 26770162, 26770163, 26770164, 26770165, 26861586, 26880769, 26880770, 26880771, 26880772, 26898042, 26898043, 26898044, 26898045, 26899812, 26899813, 26906603, 26906604, 26929712, 26929713, 26929714, 26929715, 26929716, 26929717, 26929719, 26929860, 26929861, 26957514, 26957515, 26957516, 26957517, 26969537, 26969538, 26969539, 26970440, 26970441, 26970442, 27010832, 27040235, 27040236, 27060422, 27060423, 27060424, 27060425, 27060426, 27078872, 27078873, 27084457, 27084458, 27084459, 27084960, 27100768, 27100769, 27100770, 27123402, 27123404, 27140485, 27140486, 27163487, 27163488, 27180605, 27190243, 27190244, 27190245, 27190686, 27193837, 27193838, 27193839, 27194460, 27194461, 27197622, 27197623, 27214381, 27214382, 27214383, 27224419, 27257804, 27257805, 27259062, 27259063, 27259064, 27259065, 27268186, 27268187, 27283462, 27283463, 27283464, 27283465, 27283466, 27317224, 27317225, 27317226, 27329273, 27329274, 27329275, 27358004, 27358005, 27361380, 27361381, 27382203, 27382204, 27416003, 27416004, 27416005, 27416006, 27416007, 27444898, 27444899, 27445360, 27447905, 27469811, 27469812, 27469813, 27475230, 27496957, 27496958, 27512052, 27512053, 27512054, 27512055, 27517685, 27518868, 27518869, 27528492, 27531152, 27531153, 27531154, 27531155, 27531156, 27531157, 27601494, 27601495, 27657444, 27657445, 27657446, 27670942, 27670945, 27670946, 27670949, 27705891, 27720117, 27720118, 27720119, 27745215, 27745216, 27756475, 27769338, 27769339, 27769860, 27769861, 27769862, 27769863, 27797083, 27797084, 27797085, 27797086, 27797087, 28094078, 28094079, 28094320, 28103330, 28104177, 28104178, 28104179, 28104420, 28110684, 28110685, 28110686, 28110687, 28116634, 28116635, 28138219, 28138440, 28146630, 28146631, 28169753, 28169754, 28169755, 28179669, 28179670, 28179671, 28202160, 28237387, 28237388, 28237389, 28247079, 28247160, 28247161, 28247162, 28247269, 28247270, 28247271, 28247272, 28254386, 28254387, 28254388, 28265943, 28265944, 28265945, 28265946, 28265947, 28272556, 28272557, 28272558, 28272559, 28272560, 28287355, 28287356, 28294718, 28294719, 28311111, 28311112, 28323414, 28323415, 28323416, 28323417, 28335613, 28335614, 28350366, 28350367, 28350368, 28350369, 28364006, 28364007, 28364008, 28371227, 28371228, 28371229, 28389635, 28389636, 28412353, 28419102, 28419103, 28432892, 28432893, 28473289, 28473290, 28493777, 28493778, 28499505, 28499506, 28499507, 28555843, 28565355, 28565356, 28565357, 28587389, 28587390, 28587391, 28587392, 28587393, 28587394, 28605867, 28606252, 28611099, 28612440, 28612441, 28612442, 28613189, 28635760, 28635761, 28635762, 28635763, 28654059, 28654440, 28654441, 28663263, 28663264, 28663265, 28668946, 28668947, 28668948, 28683114, 28683115, 28686271, 28686272, 28686273, 28694687, 28707785, 28709642, 28709643, 28714572, 28723144, 28734763, 28734764, 28758266, 28766992, 28766993, 28766994, 28766995, 28766996, 28811555, 28811556, 28811558, 28811560, 28819972, 28819973, 28821692, 28821693, 28822526, 28822527, 28828281, 28828282, 28836638, 28836639, 28838125
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 24, 2022

Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, Individual Packaging Label: ProTekt Sharps Safety Knives - REF: PG 44620MU,2.2mm double Bevel Slit, Sterile R, Angled 1 unit, Handle Labeling; 2.5mm slit double bevel

Surgical knives may contain incorrect description printed on handles. Specifically, some surgical knife handles may contain a size of "2.5mm" when the actual size is "2.2mm".

ALL 50 STATES
Full report

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

Recall #:
89827
Lot/product code:
Item # PG 44620MU; Lot # : B923LUC
Recalling firm:
International Science & Technology, LP, DBA Diamatrix Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2022

syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700

After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes. If this error occurs, the patient orientation/position may be misinterpreted and result in inappropriate treatment, even if the incorrect visualization is obvious.

ALL 50 STATES
Full report

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

Recall #:
90366
Lot/product code:
(1)Artis Pheno UDI-DI: 04056869046877 (2)Artis icono biplane UDI-DI: 04056869063317 (3) Artis icono floor- UDI-DI: 04056869149325 S/N: Serial 170319 180062 180054 180019 164719 164712 180065 180056 180057 180041 180421 180317 180034 164740 180349 180301 164722 180367 180382 180060 164311 170026 180337 164763 180070 180048 180083 164735 180087 180370 180371 180372 180345 180315 170367 170368 164723 180343 180080 180305 180330 170331 164743 180379 180386 164741 180360 180333 170349 170361 180029 180352 180336 180407 164728 180412 180400 180397 180316 180068 180363 170334 170336 180084 180418 180334 164711 170025 180018 180350 180376 180354 180046 180047 180335 180085 164321 180035 164718 180339 180357 180358 180361 180362 180081 180423 170346 180331 180411 180381 180021 180342 170365 170322 180321 180309 180356 180378 180393 164739 180368 180413 180341 164703 180323 170303 170378 180329 180053 180055 164721 180043 170053 180049 180377 180077 180086 180015 180014 164726 164724 164725 180066 180082 164760 180037 180373
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2022

Total Knee Pack - Surgical Kit

The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.

ALL 50 STATES
Full report

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

Recall #:
89671
Lot/product code:
SKU/Part Number 570-2676; UDI H65257026760 Lot Numbers: 20156461673, 20171461909, 20174462304, 20239463246, 20342468026, 21130473544, 21286478854, 21326479944, 22005482064
Recalling firm:
Stradis Medical, LLC dba Stradis Healthcare
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2022

Coryell Memorial Hosp Total, Joint Pack - Surgical Kit

The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.

ALL 50 STATES
Full report

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

Recall #:
89671
Lot/product code:
SKU/Part Number 690-260; UDI M7526902600 Lot Numbers: 1912331779, 1914333072, 1915433813, 1915634371, 1919334769, 1923436351, 1930338689, 1935342884, 2006644326, 2007745836, 20149461110, 20241463865, 20303466242, 20328467437, 20356468152, 21033468960, 21050471039, 21270476822
Recalling firm:
Stradis Medical, LLC dba Stradis Healthcare
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2022

Lum Lam Custom Pack - Anesthesia Kit

The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.

ALL 50 STATES
Full report

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

Recall #:
89671
Lot/product code:
SKU/Part Number 570-2674; UDI H65257026741 Lot Numbers: 21300478831 and 21314479685
Recalling firm:
Stradis Medical, LLC dba Stradis Healthcare
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2022

Anterior Hip Pack - Surgical Kit

The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.

ALL 50 STATES
Full report

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

Recall #:
89671
Lot/product code:
SKU/Part Number 570-2677; UDI H65257026770 Lot Numbers: 20170461910, 20163461674, 20170462303, 20219463245, 20238464203, 20268464581, 21082472172, 21110472562, 21138473542, 21167474498, 21287478853, 21167474498, 21349479943
Recalling firm:
Stradis Medical, LLC dba Stradis Healthcare
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2022

Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600

Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are related to the block movements function and manual rotation of the flat detector. Depending on the status of the intervention, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where clinical treatment may be delayed until an additional restart is performed

ALL 50 STATES
Full report

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

Recall #:
89870
Lot/product code:
S/N: 180062 180054 180019 180065 180056 180057 180041 180421 180317 180034 180072 180349 180367 180382 180060 180337 180070 180048 180083 180369 180370 180371 180372 180345 180315 180343 180080 180301 180305 180067 180330 180040 180379 180386 180360 180333 180029 180352 180336 180407 180412 180400 180397 180316 180068 180363 180084 180418 180334 180018 180350 180376 180354 180046 180047 180335 180085 180035 180339 180357 180358 180361 180362 180081 180423 180331 180411 180414 180381 180021 180342 180321 180309 180356 180378 180393 180368 180413 180341 180323 180329 180043 180049 180377 180077 180086 180053 180055 180015 180014 180066 180082 180037 180373  UDI: 04056869063317
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2022

Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327700

Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are related to the block movements function and manual rotation of the flat detector. Depending on the status of the intervention, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where clinical treatment may be delayed until an additional restart is performed

ALL 50 STATES
Full report

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

Recall #:
89870
Lot/product code:
S/N: Serial  170319 170026 170343 170367 170368 170305 170360 170307 170331 170349 170309 170310 170361 170351 170383 170023 170304 170328 170334 170336 170025 170346 170051 170358 170357 170333 170365 170332 170312 170027 170303 170378 170322 170053 170364   UDI: 04056869149325
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2022

Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and biplane diagnostic imaging and interventional procedures. Model: 10849000

Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are related to the block movements function and manual rotation of the flat detector. Depending on the status of the intervention, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where clinical treatment may be delayed until an additional restart is performed

ALL 50 STATES
Full report

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

Recall #:
89870
Lot/product code:
Serial Number:  164719 164712 164740 164722 164763 164735 164723 164743 164741 164728 164711 164718 164739 164703 164721 164726 164724 164725 164760  UDI: 04056869046877
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2022

DigitalDiagnost C50 1.1

Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of the image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Added 1/3/2023), Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting.

ALL 50 STATES
Full report

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

Recall #:
90728
Lot/product code:
Model Number 712204   Serial Number 210182 210187 220002 210049 210051 210097 210052 210053 210055 220020
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2022

Surgicare Neuro Pack - Neurological Kit

The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.

ALL 50 STATES
Full report

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

Recall #:
89671
Lot/product code:
SKU/Part Number 570-2224; UDI H65257022240 Lot Numbers: 20143461101, 20156461682, 20217462972, 20309467143, 20343467142, 20364467508, 20364468264, 21076471300, 21082471463, 21102472013, 21117472929, 21126473545
Recalling firm:
Stradis Medical, LLC dba Stradis Healthcare
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 28, 2022

NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size).

Product found to not comply to Class 1 Laser safety requirement.

ALL 50 STATES
Full report

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

Recall #:
90835
Lot/product code:
CDRH accession # 0510530-001
Recalling firm:
MALVERN PANALYTICAL LTD
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 28, 2022

NanoSight LM10 fitted with LM14 module. A laboratory instrument for determination of particle characteristics (e.g. size).

Product found to not comply to Class 1 Laser safety requirement.

ALL 50 STATES
Full report

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

Recall #:
90835
Lot/product code:
CDRH accession # 0510530-002
Recalling firm:
MALVERN PANALYTICAL LTD
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 28, 2022

Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States

Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate.

ALL 50 STATES
Full report

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

Recall #:
89767
Lot/product code:
All Lots & Serial Numbers ; *Distributed outside the Untied States
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 28, 2022

Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)

Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate.

ALL 50 STATES
Full report

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

Recall #:
89767
Lot/product code:
All Lots & Serial Numbers
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 28, 2022

Integra Universal Flexible Arm part number REF 1362275

Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition.

ALL 50 STATES
Full report

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

Recall #:
89830
Lot/product code:
UDI#10381780074670, Lots: AC2109, AC2103, AC2106, AC2110, AC2101, AC2008, AC2009
Recalling firm:
Integra LifeSciences Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 28, 2022

Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709)

Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate.

ALL 50 STATES
Full report

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

Recall #:
89767
Lot/product code:
All Lots & Serial Numbers. V60 UDI-DI: 00884838009844, 00884838009851, 00884838020054, 00884838025776, 00884838089280, 00884838090996.
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)