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Recalls affecting Wyoming

Data last updated: September 8, 2026 at 1:13 PM UTC

16,268 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/virusAnnounced 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/virusAnnounced 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)
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)
UnclassifiedAllergenUndeclaredAnnounced 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)
UnclassifiedBacteria/virusAnnounced 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/virusAnnounced 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 January 9, 2019

PageWriter TC30, Product 860306, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

ALL 50 STATES
Full report

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

Recall #:
81957
Lot/product code:
CN11102185 CN11102186 CN11102187 CN11102188 CN11102189 CN11102190 CN11102223 CN11102224 CN11102287 CN11204687 CN11204688 CN11204689 CN11204690 CN11204691 CN11204692 CN11204698 CN11204699 CN11204700 CN11204701 CN11204702 CN11204703 CN11204704 CN11204705 CN11204706 CN11204707 CN11204708 CN11204709 CN11204710 CN11204711 CN11204712 CN11204713 CN11204714 CN11204715 CN11204758 CN11204759 CN11204760 CN11204761 CN11204762 CN11204763 CN11204764 CN11204765 CN11204766 CN11204767 CN11204768 CN11204769 CN11204770 CN11204771 CN11204772 CN11204773 CN11204774 CN11204775 CN11204776 CN11204777 CN11204778 CN11204779 CN11204780 CN11204820 CN11306743 CN11306744 CN11306745 CN11306746 CN11306763 CN11306764 CN11306765 CN11306766 CN11306767 CN11306768 CN11306829 CN11306830 CN11306831 CN11306832 CN11306833 CN11306834 CN11510041 CN11510042 CN11510043 CN11510044 CN11510045 CN11510046 CN11510047 CN11510048 CN11510049 CN11510050 CN11510051 CN11510052 CN11510053 CN11510074 CN11510075 CN11510076 CN11510077 CN11510078 CN11510079 CN11510080 CN11510081 CN11510082 CN11510083 CN11510084 CN11510085 CN11510086 CN11510087 CN11510088 CN11510089 CN11510090 CN11510091 CN11510092 CN11510093 CN11510094 CN11510095 CN11510096 CN11510097 CN11510098 CN11630118 CN11630119 CN11630120 CN11630121 CN11630122 CN11630123 CN11630124 CN11630125 CN11630126 CN11630127 CN11630128 CN11630129 CN11630130 CN11630131 CN11630137 CN11630139 CN11630140 CN11630141 CN11630142 CN11630149 CN11630150 CN11630151 CN11630152 CN11630153 CN11630154 CN11630155 CN11630156 CN11630157 CN11630158 CN11630159 CN11630160 CN11630161 CN11630162 CN11630163 CN11630164 CN11630165 CN11630186 CN11630187 CN11630188 CN11630189 CN11630190 CN11630191 CN11630192 CN11630193 CN11630194 CN11630195 CN11731415 CN11731422 CN11731423 CN11731424 CN11731425 CN11731426 CN11731427 CN11731428 CN11731429 CN11731430 CN11731431 CN11731432 CN11731433 CN11731434 CN11731435 CN11731436 CN11731437 CN11731438 CN11731439 CN11731440 CN11731441 CN11731442 CN11731443 CN11731444 CN11731445 CN11731446 CN11731447 CN11731448 CN11731449 CN11731450 CN11731452 CN11731453 CN11731454 CN11731455 CN11731456 CN11731457 CN11731463 CN11731464 CN11731465 CN11731466 CN11731467 CN11731468 CN11731469 CN11832357 CN11832358 CN11832359 CN11832360 CN11832361 CN11832362 CN11832363 CN11832368 CN11832369 CN11832370 CN11832371 CN11832372 CN11832373 CN11832378 CN11832379 CN11832380 CN11832381 CN11832382 CN11832383 CN11832384 CN11832385 CN11832386 CN11832387 CN11832388 CN11832389 CN11832390 CN11832391 CN11832392 CN11832393 CN11832394 CN11832395 CN11832396 CN11832397 CN11832398 CN11832399 CN11832405 CN11832406 CN11832407 CN11832408 CN11832409 CN11832410 CN11832411 CN11832412 CN11832413 CN11832414 CN11832415 CN11832416 CN11832417 CN11832418 CN11832419 CN11832420 CN11832421 CN11832422 CN11832423 CN11832424 CN11832425 CN11832426 CN11832427 CN11832428 CN11832429 CN11832430 CN11832431 CN11832432 CN11832434 CN11832435 CN11832436 CN11832437 CN11832438 CN11832439 CN11832440 CN11832441 CN11832442 CN11832443 CN11832444 CN11832445 CN11832446 CN11832447 CN11832448 CN11832449 CN11832450 CN11832451 CN11832452 CN11832453 CN11832454 CN21102482 CN21102483 CN21102484 CN21102485 CN21102486 CN21102487 CN21204898 CN21204899 CN21204902 CN21204903 CN21204904 CN21204905 CN21204913 CN21204914 CN21204915 CN21204916 CN21204917 CN21204918 CN21204919 CN21204920 CN21204921 CN21204922 CN21204923 CN21204924 CN21204925 CN21204926 CN21204927 CN21204928 CN21204929 CN21204930 CN21204931 CN21204932 CN21204933 CN21204934 CN21204935 CN21204936 CN21204937 CN21204938 CN21204939 CN21204940 CN21204941 CN21204942 CN21204943 CN21204944 CN21204945 CN21204946 CN21204947 CN21205039 CN21205068 CN21205069 CN21205070 CN21205071 CN21205072 CN21205073 CN21205074 CN21205075 CN21205076 CN21205077 CN21205078 CN21205079 CN21205080 CN21205081 CN21205082 CN21205083 CN21205093 CN21205094 CN21306944 CN21306947 CN21306948 CN21306949 CN21306950 CN21306951 CN21408619 CN21408620 CN21510155 CN21510156 CN21510157 CN21510158 CN21510159 CN21510160 CN21510161 CN21510162 CN21510163 CN21510164 CN21510165 CN21510166 CN21510167 CN21510168 CN21510169 CN21510170 CN21510171 CN21510172 CN21510173 CN21510174 CN21510206 CN21510207 CN21510208 CN21510209 CN21510210 CN21510211 CN21510212 CN21510213 CN21510214 CN21510215 CN21510216 CN21510217 CN21510218 CN21510221 CN21510232 CN21510233 CN21510234 CN21510235 CN21510236 CN21510237 CN21510238 CN21510239 CN21510240 CN21510241 CN21510242 CN21510243 CN21510244 CN21510245 CN21510246 CN21510247 CN21510248 CN21510249 CN21510327 CN21510328 CN21510329 CN21510330 CN21510331 CN21510332 CN21510333 CN21510334 CN21510335 CN21510336 CN21510337 CN21510338 CN21510341 CN21510342 CN21510343 CN21510344 CN21510345 CN21510346 CN21510347 CN21510348 CN21510349 CN21510350 CN21510351 CN21510352 CN21510353 CN21510354 CN21510355 CN21510356 CN21510357 CN21510358 CN21510359 CN21630261 CN21630262 CN21630263 CN21630264 CN21630265 CN21630266 CN21630267 CN21630268 CN21630269 CN21630272 CN21630273 CN21630274 CN21630275 CN2163… (truncated, 145628 characters total — see the official FDA record for the full value)
Recalling firm:
Philips North America, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 9, 2019

PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

ALL 50 STATES
Full report

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

Recall #:
81957
Lot/product code:
US41510645 US41510646 US71630792 USN1206382 USN1206383 USN1409879 USO1631023
Recalling firm:
Philips North America, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 9, 2019

PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

ALL 50 STATES
Full report

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

Recall #:
81957
Lot/product code:
CN11102314 CN11102315 CN11102316 CN11102317 CN11203436 CN11203443 CN11203444 CN11203453 CN11203454 CN11203455 CN11304748 CN11304749 CN11304762 CN11304772 CN11304773 CN11304802 CN11304803 CN11304805 CN11304806 CN11304809 CN11406020 CN11406033 CN11406034 CN11507236 CN11507237 CN11507238 CN11507259 CN11507260 CN11507261 CN11507262 CN11507263 CN11507264 CN11630099 CN11630100 CN11630101 CN11630102 CN11630103 CN11630104 CN11630105 CN11630106 CN11630107 CN11630108 CN11630109 CN11630110 CN11630111 CN11630112 CN11630113 CN11630114 CN11630122 CN11630123 CN11630124 CN11630125 CN11630126 CN11630128 CN11630129 CN11630130 CN11630131 CN11630132 CN11630133 CN11630134 CN11630135 CN11630136 CN11630138 CN11630139 CN11630140 CN11630141 CN11630142 CN11630143 CN11630144 CN11630145 CN11630146 CN11630147 CN11630148 CN11630149 CN11630150 CN11630151 CN11630154 CN11630155 CN11630156 CN11630157 CN11630158 CN11630159 CN11630160 CN11630164 CN11630165 CN11630166 CN11630173 CN11630174 CN11630175 CN11630176 CN11630177 CN11630178 CN11630179 CN11630180 CN11630181 CN11630182 CN11630183 CN11630184 CN11630185 CN11630186 CN11630187 CN11630188 CN11630189 CN11630190 CN11630191 CN11630192 CN11630193 CN11630194 CN11630195 CN11630196 CN11630197 CN11630198 CN11630199 CN11630200 CN11630201 CN11630202 CN11630203 CN11630204 CN11731556 CN11731557 CN11731558 CN11731559 CN11731560 CN11731561 CN11731562 CN11731563 CN11731564 CN11731565 CN11731566 CN11731567 CN11731568 CN11731575 CN11731576 CN11731577 CN11731578 CN11731579 CN11731580 CN11731581 CN11731582 CN11731583 CN11731584 CN11731585 CN11731586 CN11731593 CN11731594 CN11840066 CN11840067 CN11840068 CN11840069 CN11840071 CN11840072 CN11840073 CN11840080 CN11840081 CN11840082 CN11840083 CN11840084 CN11840085 CN11840086 CN11840087 CN11840088 CN11840089 CN11840090 CN11840091 CN11840092 CN11840093 CN11840094 CN11840095 CN11840096 CN11840097 CN11840098 CN11840099 CN11840100 CN11840101 CN11840103 CN11840104 CN11840105 CN11840106 CN11840107 CN11840108 CN11840109 CN11840110 CN11840111 CN11840112 CN11840113 CN11840114 CN11840115 CN11840116 CN11840117 CN11840118 CN11840119 CN11840120 CN11840121 CN11840122 CN11840123 CN11840124 CN11840125 CN11840126 CN21102408 CN21102409 CN21102420 CN21102431 CN21203548 CN21203549 CN21203558 CN21203563 CN21203564 CN21203565 CN21203566 CN21203567 CN21203568 CN21203677 CN21304888 CN21304889 CN21304890 CN21304901 CN21304902 CN21304903 CN21304904 CN21406160 CN21406161 CN21406162 CN21406163 CN21406164 CN21406165 CN21406166 CN21406167 CN21406168 CN21406169 CN21406170 CN21406171 CN21406172 CN21406173 CN21507275 CN21507297 CN21507298 CN21507299 CN21507300 CN21507301 CN21507302 CN21507303 CN21507304 CN21507313 CN21507314 CN21507316 CN21507317 CN21507318 CN21507319 CN21507320 CN21507321 CN21507368 CN21507369 CN21507370 CN21507371 CN21507372 CN21507373 CN21507374 CN21507375 CN21507376 CN21507377 CN21507378 CN21507379 CN21507380 CN21507381 CN21507382 CN21630218 CN21630219 CN21630220 CN21630221 CN21630222 CN21630223 CN21630224 CN21630225 CN21630226 CN21630227 CN21630228 CN21630229 CN21630230 CN21630231 CN21630232 CN21630233 CN21630234 CN21630235 CN21630236 CN21630237 CN21630238 CN21630239 CN21630240 CN21630241 CN21630242 CN21630243 CN21630244 CN21630245 CN21630246 CN21630247 CN21630248 CN21630249 CN21630250 CN21630251 CN21630252 CN21630253 CN21630254 CN21630255 CN21630256 CN21630257 CN21630258 CN21630259 CN21630260 CN21630261 CN21630262 CN21630263 CN21630264 CN21630265 CN21630266 CN21630267 CN21630268 CN21630286 CN21630287 CN21630290 CN21630291 CN21630292 CN21630293 CN21630294 CN21630295 CN21630296 CN21630297 CN21630298 CN21630299 CN21630300 CN21630301 CN21630302 CN21630303 CN21731603 CN21731604 CN21731605 CN21731612 CN21731613 CN21731614 CN21731615 CN21731616 CN21731617 CN21731618 CN21731620 CN21731621 CN21731622 CN21731623 CN21731624 CN21731625 CN21731626 CN21731653 CN21731654 CN21731655 CN21731656 CN21731657 CN21731658 CN21731659 CN21731660 CN21731661 CN21731662 CN21731663 CN21731664 CN21731665 CN21731666 CN21731667 CN21731668 CN21731669 CN21731670 CN21731672 CN21731673 CN21731674 CN21731675 CN21731676 CN21731677 CN21731678 CN21731679 CN21731680 CN21731681 CN21731682 CN21731683 CN21731684 CN21731685 CN21731686 CN21731687 CN21731688 CN21731689 CN21731690 CN21731691 CN21731692 CN21731693 CN21731694 CN21731695 CN21731696 CN21731697 CN21731698 CN21731699 CN21731700 CN21731701 CN21731702 CN21731703 CN21731704 CN21731705 CN21731706 CN21731707 CN21731708 CN21731709 CN21731710 CN21731711 CN21731715 CN21731716 CN21731717 CN21731718 CN21731719 CN21731720 CN21731721 CN21840127 CN21840128 CN21840129 CN21840130 CN21840131 CN21840174 CN21840175 CN21840176 CN21840177 CN21840178 CN21840179 CN21840180 CN21840181 CN21840182 CN21840183 CN21840184 CN21840185 CN31102445 CN31102448 CN31102449 CN31102450 CN31102451 CN31102456 CN31102457 CN31102458 CN31102459 CN31102460 CN31102461 CN31102462 CN31102477 CN31102488 CN31102489 CN31102520 CN31102521 CN31102522 CN31102547 CN31203690 CN31203691 CN31203697 CN31203698 CN3120… (truncated, 124651 characters total — see the official FDA record for the full value)
Recalling firm:
Philips North America, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 10, 2019

AutoDELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG).

HCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.

ALL 50 STATES
Full report

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

Recall #:
82064
Lot/product code:
Kit Lot Numbers: 664670, 666553 Pack Lot Numbers: 1066467001, 1066467002, 1066655301 UDI: (01)06438147009336(17)190430(10)664670 (01)06438147009336(17)190430(10)666553
Recalling firm:
PerkinElmer Life and Analytical Sciences, Wallac, OY
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 10, 2019

AutoDELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG).

HCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.

ALL 50 STATES
Full report

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

Recall #:
82064
Lot/product code:
Kit Lot Numbers: 664303 Pack Lot Numbers: 1066430301, 1066430302 UDI: (01)06438147009343(17)190430(10)664303
Recalling firm:
PerkinElmer Life and Analytical Sciences, Wallac, OY
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 10, 2019

DELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.

HCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.

ALL 50 STATES
Full report

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

Recall #:
82064
Lot/product code:
Kit Lot Numbers: 664891, 666471, 666604 Pack Lot Numbers: 1066489101, 1066647101,1066660401 UDI:  (01)06438147009176(17)190430(10)664891 (01)06438147009176(17)190430(10)666471 (01)06438147009176(17)190430(10)666604
Recalling firm:
PerkinElmer Life and Analytical Sciences, Wallac, OY
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 10, 2019

EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.

User-induced circumstances can contribute to the EVOLIS Microplate Processor System not handling repeat testing requests/results properly and may contribute to transmitting erroneous results to the customer's Laboratory Information System (LIS).

ALL 50 STATES
Full report

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

Recall #:
82920
Lot/product code:
Software version 1.4, UDI for the software is 03610520562024.
Recalling firm:
Bio-Rad Laboratories, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 16, 2019

daVinci Harmonic ACE Curved Shears

During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Harmonic ACE Inserts may become damaged during transit. The potential damage includes pinholes and /or small openings (less than a few millimeters) on the pouch leading to a potential breach in sterility.

ALL 50 STATES
Full report

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

Recall #:
81972
Lot/product code:
All Lots
Recalling firm:
Intuitive Surgical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 16, 2019

Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric balloon near its distal tip designed to occlude the ascending aorta in order to partition the aortic root from arterial circulation. The balloon expands to occlude a range of aorta sizes from 20 to 40 mm. The large central lumen of the IntraClude Device serves three functions: accommodating the guidewire, delivering cardioplegia solution to the aortic root, and venting fluid and air from the aortic root. The two remaining lumens serve as conduits for balloon inflation/deflation and aortic root pressure monitoring.

Edwards Lifesciences has received a limited number of customer reports regarding an inter-lumen leak between the cardioplegia lumen and pressure lumen in the device.

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Full report

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

Recall #:
81928
Lot/product code:
60850886 60850888 60850885 60850889 60850890 60876468 60760965 60887217 60887219 60887220 60934623 60887218 60934624 60930494 60934625 60972889 60972890 60972892 61014406 61014408 61014410 61014411 61050171 61050172 61078032 61078031 61097633 61139240 61139239 61139241 61139242 61184965 61184964 61184966 61184967 61204586 61204587 61259626 61259627 61259628 61259629 61288501 61369214 61369215 61369216 61369217 61425732 61425734 61425733 61495692 61517743 61495693 61531653 61531655 61704542 61531654 61704656 61713205 61713206 61713208 61713211 61713207 61713209 61713210 61713216 61713217 61713212 61713214 61713213 61713215
Recalling firm:
Edwards Lifesciences, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 17, 2019

Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01 (b) Model Number ATDRL1 (c) Model Number ATDRS1

A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality

ALL 50 STATES
Full report

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

Recall #:
81945
Lot/product code:
ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR):  (a) Model Number ATDR01, GTIN: 00643169882911, 00763000109059, All Serial Numbers  (b) Model Number ATDRL1, GTIN: 00643169882928, 00763000109066, All Serial Numbers  (c) Model Number ATDRS1, GTIN: 00643169882935, 00763000109073, All Serial Numbers
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 17, 2019

vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-series, Model Numbers: G70A1, G70A2 (d) Q-series, Model Numbers: Q50A2, Q70A2, Q80A2

A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality

ALL 50 STATES
Full report

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

Recall #:
81945
Lot/product code:
vitatron (implantable pulse generator):  (a) A-series, Model Number: A30A1, GTIN 00643169709331; A60A1, GTIN 00643169709294, All Serial Numbers (b) E-series, Model Number: E50A1, GTIN 00643169709126, 00643169709140; E60A1, GTIN 00643169709164, 00643169709188, All Serial Numbers (c) G-series, Model Numbers: G70A1, GTIN 00643169709249, 00643169709263; G70A2, GTIN 00643169883000, All Serial Numbers (d) Q-series, Model Number: Q50A2, GTIN 00643169883017; Q70A2, GTIN 00643169882980; Q80A2, GTIN 00643169882997, All Serial Numbers
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 17, 2019

Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01

A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality

ALL 50 STATES
Full report

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

Recall #:
81945
Lot/product code:
Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01, GTIN: 00643169708969, 00643169708983, 00643169709072, All Serial Numbers
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 17, 2019

Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01

A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality

ALL 50 STATES
Full report

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

Recall #:
81945
Lot/product code:
RELIA, Dual chamber pacemaker (VDD):  (a) Model Number RED01, GTIN: 00643169709003, All Serial Numbers  (b) Model Number REDR01, GTIN: 00643169708990, 00643169969742, All Serial Numbers  (c) Model Number REVDD01, GTIN: 00643169709010, 00643169969773, All Serial Numbers
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 17, 2019

Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number ADDR01 (c) Model Number ADDR03 (d) Model Number ADDR06 (e) Model Number ADDRL1 (f) Model Number ADDRS1 (g) Model Number ADVDD01

A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality

ALL 50 STATES
Full report

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

Recall #:
81945
Lot/product code:
ADAPTA, Dual chamber pacemaker (DDD):  (a) Model Number ADD01, GTIN: 00643169708754, All Serial Numbers  (b) Model Number ADDR01, GTIN: 00643169708587, 00643169708594, 00643169708600, 0643169708624, 00643169969711, All Serial Numbers   (c) Model Number ADDR03, GTIN: 00643169708631, 00643169708648, All Serial Numbers  (d) Model Number ADDR06, GTIN: 00643169708655, 00643169708662, All Serial Numbers  (e) Model Number ADDRL1, GTIN: 00643169518247, 00643169708679, 00643169708686, 00643169708709, 00643169969803, All Serial Numbers  (f) Model Number ADDRS1, GTIN: 00643169708716, 00643169708723, 00643169708730, 00643169708747, 00643169969810, All Serial Numbers   (g) Model Number ADVDD01, GTIN: 00643169708761, 00643169708778, 00643169969735, All Serial Numbers
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 17, 2019

Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1

A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality

ALL 50 STATES
Full report

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

Recall #:
81945
Lot/product code:
SENSIA, Dual chamber pacemaker (DDD):  (a) Model Number SED01, GTIN 00643169708914, All Serial Numbers (b) Model Number SEDR01, GTIN 00643169708877, 00643169708891, 00643169969780, All Serial Numbers (c) Model Number SEDRL1, GTIN 00643169708907, All Serial Numbers
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 17, 2019

Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1

A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality

ALL 50 STATES
Full report

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

Recall #:
81945
Lot/product code:
Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR):  (a) Model Number SPDR01, GTIN 00643169882959, 00763000109097, All Serial Numbers  (b) Model Number SPDRL1, GTIN 00643169882966, 00763000109103, All Serial Numbers
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 18, 2019

Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-330-03

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0413-2019
Lot/product code:
325D18004 325D18005
Recalling firm:
Prinston Pharmaceutical Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 18, 2019

Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 30 count - NDC 43547-331-03

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0411-2019
Lot/product code:
327A18001 327A18002
Recalling firm:
Prinston Pharmaceutical Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 18, 2019

Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg Rx Only 90 count Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-330-09

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0410-2019
Lot/product code:
325B18004
Recalling firm:
Prinston Pharmaceutical Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 18, 2019

Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 90 count NDC 43547-331-09

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0412-2019
Lot/product code:
327B18008 327B18009
Recalling firm:
Prinston Pharmaceutical Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 18, 2019

Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-376-09

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0409-2019
Lot/product code:
331B18009
Recalling firm:
Prinston Pharmaceutical Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 19, 2019

Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

Additional low dose radiation exposure.

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Full report

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

Recall #:
83254
Lot/product code:
Revolution CT
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 28, 2019

ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869050775 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values based on PW Doppler are calculated normally but not loaded correctly into hardware

ALL 50 STATES
Full report

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

Recall #:
83398
Lot/product code:
All product lots of the Acuson NX2, model # 11284500 containing the following software: VA10A, VA10B,VA10C, VA11A, VA11B, VA11C
Recalling firm:
Siemens Medical Solutions USA, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 28, 2019

ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056869004297 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values based on PW Doppler are calculated normally but not loaded correctly into hardware

ALL 50 STATES
Full report

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

Recall #:
83398
Lot/product code:
All product lots of the Acuson NX3, model # 11235612 containing the following software version: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B;
Recalling firm:
Siemens Medical Solutions USA, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 28, 2019

ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869030005 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values based on PW Doppler are calculated normally but not loaded correctly into hardware

ALL 50 STATES
Full report

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

Recall #:
83398
Lot/product code:
All product lots of the Acuson NX2, model # 11284381 containing the following software: VA10A, VA10B,VA10C, VA11A, VA11B, VA11C
Recalling firm:
Siemens Medical Solutions USA, Inc.
View official FDA record (opens in a new tab)