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Recalls affecting New Jersey

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

17,172 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 November 16, 2021

Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement pumps, part #AI5511, a component of model numbers 756000 and 757000.

Increase in premature device failures

ALL 50 STATES
Full report

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

Recall #:
88984
Lot/product code:
Shipped between March 2019 and February 2021.
Recalling firm:
Ohio Medical Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 17, 2021

Senior Living Arial Emergency and Nurse Call Systems

Systems are not alarming due to increased memory consumption.

ALL 50 STATES
Full report

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

Recall #:
89181
Lot/product code:
Model No. 0900-989; Lot No.: 7VQYZB3, G1GG8B3, 1TX2613, 7VQWZB3, GRRT243, 1TX3613, G1H58B3, HJP7N23, HJP9N23, 51SDR33, and GRRV243; UDI No.: (01)00840948100987(21)7VQYZB3, (01)00840948100987(21)1TX2613, (01)00840948100987(21)7VQZZB3, (01)00840948100987(21)GRRT243, (01)00840948100987(21)G1GF8B3, (01)00840948100987(21)1TX3613, (01)00840948100987(21)G1H58B3, (01)00840948100987(21)HJP7N23, (01)00840948100987(21)HJP9N23, (01)00840948100987(21)51SDR33, (01)00840948100987(21)GRRV243
Recalling firm:
Stanley Security Solutions Inc
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled November 17, 2021

Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only; 0.4 mL Syringes, Manufactured for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-02; Carton (10 x 0.4 mL Syringes), Manufactured by Shenzhen Techdow Pharmaceutical Co., Ltd. Shenzhen City, Guangdong Province 518057, China for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-64

Temperature Abuse; temperature excursion during shipping

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0286-2022
Lot/product code:
Lot #SAB06761A, exp 04/2023
Recalling firm:
Sandoz Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2021

Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000

(1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Value would shift test results by the magnitude of the implemented Assay Correlation factor; (2) On Board Stability (OBS) Not Updating with Manual Change for Open Channel Assays may continue to use the reagent past its expiration date leading to potential erroneous patient sample results

ALL 50 STATES
Full report

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

Recall #:
89160
Lot/product code:
Software version: V1.25.1 and lower. UDI: 00630414002163
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 19, 2021

SOMATOM Confidence -Computed tomography systems Model 10590100

Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.

ALL 50 STATES
Full report

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

Recall #:
89208
Lot/product code:
Serial Numbers: 100172 100091 100112 100362 100278 100158 100143 100129 100237 100238 100191 100356 100425 100216 100307 100325 100328 100329 100326 100239 100461 100213 100070 100062 100072 100022 100107 100241 100157 100055 100340 100347 100137 100267 100190 100252 100438 100046 100197 100092 100202 100313 100311 100043 100136 100189 100283 100156 100079 100049 100056 100147 100262 100018 100240 100117 100097 100274 100242 100099 100383 100059 100289 100312 100174 100073 100016 100182 100146 100058 100170 100175 100292 100090 100271 100463 100257 100273 100067 100160 100218 100367 100087 100309 100284 100207 100405 100261 100025 100338 100272 100053 100019 100421 100280 100357 100220 100214 100393 100394 100486 100140 100085 100279 100254 100353 100298 100379 UDI: UDI 04056869011011
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 19, 2021

Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455

A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well that had a positive sample may cause further cross-contamination in areas of the lab if not properly cleaned.

ALL 50 STATES
Full report

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

Recall #:
89098
Lot/product code:
Kit Product Code MOL1455 (UDI 01-30816101025092) contains 3 discs with Disc Product Code MOL1452. Below lists the MOL1455 Kit Lot numbers (and MOL1452 Disc Lot Numbers):  12410N (12152N), 12411N (12147N), 12413N (12149N), 12477N (12150N), 12602N (11548NA), 12603N (12144N), 12721N (12148N), 12889N (12151N), 13369N (12817N), 13370N (13151N), 13434N (12382N), 13652N (12835N), and 13242N (12154N)*.  *Kit Lot #13242N (Disc Lot #12154N) was shipped to Europe and not within the US.
Recalling firm:
DiaSorin Molecular LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 19, 2021

SOMATOM Definition Edge -Computed tomography system Model 10590000

Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.

ALL 50 STATES
Full report

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

Recall #:
89208
Lot/product code:
Serial Numbers: 155403 84012 83047 83095 83915 83801 155351 155658 155353 83826 83754 83277 83249 83904 155521 83632 83743 155578 83931 83979 155393 155396 155413 155489 83238 83336 83984 83401 84006 83834 155671 155649 83562 155341 83564 155613 83582 155606 83596 155596 155485 155437 83934 83746 83234 83971 155573 155335 83321 155422 83332 155459 155382 83994 83026 83330 155501 155639 155535 83281 83558 83767 155600 83880 83683 155360 155361 155564 83339 155580 83244 155615 83585 83899 155504 155315 155592 83613 83852 83226 83271 83607 84011 155405 83403 83599 155373 83695 83937 83246 83388 83668 155642 155343 155554 155399 83584 83837 83591 155616 83878 83714 155463 155447 155630 83574 155318 83567 83832 83886 83662 83763 83308 155312 155557 83871 83375 83988 155629 155637 83227 83359 83031 155364 83520 83262 155502 155627 84019 83903 83901 155524 84024 155513 83798 83292 83243 83319 83294 83544 83637 83640 83705 83083 83096 83707 155354 155507 83581 83717 155634 155632 83728 83056 83950 155559 83382 83819 83041 83363 83307 155388 84020 83732 83752 155581 155584 155569 155427 83961 155329 83845 83236 83348 155374 155365 83846 83399 155601 83749 83847 155322 83786 155300 155636 83975 84016 155389 83914 83842 83775 83084 83004 155358 155623 83669 155443 155304 83014 83573 155655 155515 83796 83274 94801 83768 155575 83684 83552 83210 84001 83537 83233 83352 83569 83909 155532 83968 155348 155585 83711 83697 155572 83991 155668 83395 155356 155357 155660 155442 155582 155342 155530 83621 83859 83335 83278 83742 83018 83322 83392 155558 155350 83279 83276 83365 83970 83928 83015 83093 83327 83091 83946 83207 83938 155316 83230 83254 83680 83708 83945 155594 155621 155605 83291 155549 155328 83203 83214 83913 83896 155583 155614 83790 83875 155553 83232 83362 83824 83306 83542 84010 155384 155448 155506 155412 155493 83942 83941 84017 83981 155566 83257 155576 155495 83057 83539 83810 155579 83758 155497 83239 83398 83565 83313 83653 83957 83347 83349 84027 83323 83739 155369 83266 155510 83522 83898 83951 83387 155400 83733 155407 155371 155638 83823 155434 155309 155653 155386 155570 83611 83633 83985 155380 83967 83589 UDI: UDI 04056869006949
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 19, 2021

SOMATOM Definition AS-Computed tomography system Model 8098027

Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.

ALL 50 STATES
Full report

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

Recall #:
89208
Lot/product code:
Serial Numbers: 96278 96887 66027 64492 64541 64519 64427 67297 95303 96267 64864 96211 59802 67241 64798 98423 65597 95389 96689 64419 64347 64860 64382 64869 65238 66734 92078 95804 96471 98402 95985 96710 95889 95778 92353 95847 95936 67236 64464 64471 65852 95798 96454 96466 95363 64927 91966 98354 95934 96279 95807 95602 95639 65288 64773 95229 65297 65159 64036 95628 66143 64317 95610 98474 95859 95939 95601 95070 95882 95596 95791 66219 65752 98356 95677 64104 66506 66312 95844 95670 66858 65382 98424 66588 92280 67399 64413 64559 64235 66611 92056 92261 92342 95684 66319 95545 96547 95702 95766 67218 67128 64859 95788 64487 96491 65370 95234 95466 95809 67098 95616 59819 66032 95372 95461 95043 66087 95582 95143 67363 96950 65768 92186 96941 95951 95100 98422 98413 66600 64030 66844 66649 66635 95299 66225 66842 66916 95584 95151 66188 66355 64022 92375 95578 96777 66467 98417 64498 64763 64372 95362 65788 65015 66150 96647 66933 96472 98366 65299 66461 66604 65115 66441 96948 95196 92184 92131 65515 66498 96380 96973 66197 66688 66164 95777 65769 95609 96424 96020 66768 65304 67233 95742 92298 64825 96413 96015 96824 65770 59825 67310 64066 66201 66406 66574 96529 95856 96544 65713 66700 65926 66503 98404 65443 96305 95881 95845 98364 96845 65804 95280 96773 96455 66126 65478 95923 95903 96747 67116 96726 95095 96370 98445 95940 64516 95784 98403 65407 65251 64720 92335 92300 66969 96750 96530 64685 66001 96038 96863 96992 95175 95457 95459 66928 65403 96341 66542 95465 92358 96984 67175 65740 66690 95451 67326 95274 95875 95983 67380 65555 64709 65291 66965 66151 67181 95891 64314 95181 66557 96633 96543 96669 66148 96335 95892 67288 67085 64446 92180 66705 96823 65418 95152 96421 67133 67048 95411 64677 67319 95960 64740 59820 98441 65755 66019 66062 92023 96014 96865 65501 66234 64221 98449 98357 95893 65927 65186 95659 59803 95193 98363 96709 96351 95413 64211 96385 95848 98359 96785 156012 66478 66850 96443 96749 92053 95437 96346 95272 64218 95207 64480 64947 95393 96893 96438 66999 95846 64463 65283 96369 95485 64835 64913 64834 64942 96316 96028 92243 66011 95647 67391 96812 66297 65818 96418 95344 92321 66618 96288 66396 96238 95080 96676 92101 96352 96444 92313 92177 96271 66473 66423 66304 66349 67010 67108 95438 95439 95751 95710 96336 96324 67229 65611 67126 65936 66958 65709 65556 92033 92296 96312 95906 96896 96021 92254 65735 95768 95715 91964 64489 64732 92169 98401 66183 65793 96937 95928 95968 98447 64051 95014 65728 96832 64282 95174 64031 66587 66789 64056 95425 67291 95415 64729 65235 64999 98411 66232 98350 66290 65229 96226 92132 65925 65148 95818 64060 95661 65455 64960 96340 66173 65145 64110 96929 66918 66808 96697 66843 92347 92307 65844 95339 95022 95748 95199 65779 96553 96303 65272 95646 95034 66021 66095 99401 96022 65151 96828 67312 96338 95302 64568 59828 65610 64248 96023 67169 67193 96545 64602 64707 66237 64096 98353 95952 65079 65831 92087 95868 96991 96942 92336 96899 64501 66308 95378 96266 65003 66792 95737 67274 96922 95912 65808 92207 92125 95361 65800 95961 95701 95376 96328 65557 65371 92315 66356 66381 96713 66821 95580 66812 64572 64967 65022 64052 65795 66221 67036 95427 65173 64407 65848 66930 66077 95782 95938 67251 95972 66116 95192 96851 65586 96250 96776 96347 96310 92058 64998 66457 66502 65154 66490 92088 95785 92099 92288 95522 64238 66110 59823 59829 64094 65659 66248 98473 66579 64796 64500 96425 95493 96061 96861 95593 64983 66931 66288 59824 98442 59822 96736 98414 95678 64247 66529 96541 92113 64322 95342 96983 64148 65760 65865 66265 66335 65854 95786 96524 65017 66813 96925 96909 98352 59812 96589 96440 98409 95592 66081 64924 64934 65701 66082 65909 64813 59814 96677 95221 95703 92108 65347 65392 92091 66925 95087 96717 92176 95517 98362 67232 96821 66076 66536 66041 64019 64767 66689 95441 66407 96857 95947 95484 65493 95521 95059 95359 65365 65803 65956 96837 64160 64605 64064 95021 95013 66023 95499 96967 64675 92189 96538 96668 66510 95924 95498 95147 98452 95808 66403 92409 91968 92000 66470 65680 65805 95575 96049 96040 95591 92323 66223 66540 96268 59815 67192 66630 95719 66280 95079 64908 65247 92057 95632 92208 92155 92165 96542 96740 66859 64297 95559 65995 67321 95797 95758 95145 96864 96281 66664 65667 96058 65157 96463 95440 95549 66434 66017 95577 96302 95523 66445 95674 65773 67083 156018 95642 95717 91996 92164 96053 66677 95520 96956 96011 95937 91974 66462 96327 96326 95402 96645 95025 96286 96700 96029 66882 91990 96604 95024 64196 65906 95927 96364 96397 67392 95886 65829 64712 64132 92045 65866 65743 65830 65694 65303 95195 92069 95640 98421 67167 95510 66771 95635 96695 65777 66860 66694 96062 65368 92098 95914 95657 65758 95513 66425 96275 96003 95529 98418 98419 64785 95716 65998 66447 65652 66959 UDI: UDI 04056869003665
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 19, 2021

SOMATOM Edge Plus-Computed tomography system Model 1026700

Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.

ALL 50 STATES
Full report

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

Recall #:
89208
Lot/product code:
Serial Numbers: 122022 122185 122098 122062 122099 122121 122146 122054 122082 122080 122020 122164 122116 122008 122036 122029 122044 122172 122074 122075 122049 122194 122141 122167 122156 122183 122081 122126 122129 122090 122130 122179 122089 122085 122037 122009 122163 122177 122066 122064 122038 122161 122132 122171 122153 122168 122158 122144 122063 122086 122035 122041 122112 122114 122107 122101 122108 122109 122162 122187 122174 122125 122178 122011 122182 122052 122034 122057 122145 122147 122050 122106 122189 122180 122061 122051 122166 122170 122092 122004 UDI: UDI 04056869006949
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled November 19, 2021

AmericanScreening HAND SANITIZER (ethyl alcohol 70%) ANTIMICROBIAL FORMULA Vitamin E & Moisturizer, 8 FL OZ (237 mL) bottle with either a black or clear top, Distributed by American Screening LLC Shreveport, LA, 71106 UPC 8 40050 51579 2

Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0266-2022
Lot/product code:
Black capped bottles have no lot numbers but include expiration dates of 5/21/2022 and 05/24/2022. Clear capped bottles have neither lot numbers nor expiration dates.
Recalling firm:
American Screening LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 21, 2021

QIAcube Connect MDx, Model No. 9003070

During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minimal volume to be loaded", but the indicated volume is instead the exact volume that should be loaded. Misunderstanding the guidance may lead to over diluted, under diluted, or improperly lysed sample, which in turn could lead to false negative or false positive results.

ALL 50 STATES
Full report

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

Recall #:
90758
Lot/product code:
UDI-DI (GTIN): 04053228039129 Serial Numbers (U.S.) 30000 30009 30027 30039 30049 30061 30073 30002 30010 30028 30041 30050 30062 30075 30003 30132 30031 30042 30051 30063 30078 30004 30013 30032 30043 30053 30064 30080 30005 30016 30034 30044 30057 30065 30082 30006 30019 30035 30045 30058 30067 30089 30007 30021 30033 30046 30059 30069 30090 30008 30023 30037 30047 30060 30071 30093 30094 30095 30097 30102 30104 30109 30112 30114 30115 30117 30118 30119 30121 30124 30127 30128 30129 30130 30131 30133 30134 30136 30138 30139 30140 30141 30143 30145 30106 30025 30077 30054 30055 30066 30076
Recalling firm:
Qiagen Sciences LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 22, 2021

VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack

Lower than expected results for VITROS Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190.

ALL 50 STATES
Full report

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

Recall #:
89183
Lot/product code:
Lot # 2190; Product code(unique Device Identifier): 8430373 (10758750004898)
Recalling firm:
Ortho-Clinical Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 23, 2021

1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis recording system is a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac, interventional Radiology, and surgical studies.

Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD12A, which could cause possible hazard to patients, operators, or other persons and equipment. Under certain sporadic circumstances, the CO (Cardiac Output) measurement using the Thermodilution method will temporarily no longer be possible.

ALL 50 STATES
Full report

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

Recall #:
89199
Lot/product code:
1. Sensis- 10764561; UDI: 04056869010137; Serial Numbers: 103493, 103432, 103466 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199; Serial Numbers: 103137, 103144, 103453, 103108, 103111, 103047, 103048, 103171, 103182, 103193, 103301, 103170, 103223,, 103225, 103247, 103313, 103315, 103196, 103198, 103166, 103173, 103177, 103184, 103186, 103199, 102326, 103139, 103161, 103167, 103168, 103172, 103178, 100263, 103424, 103319, 103320, 103321, 103323, 103325, 103328, 103330, 103333, 103334, 103335, 103344, 100216, 103337, 100416, 102008, 103413, 101083, 100208, 100209, 102138, 102145, 102147, 103160, 103314, 102199, 103079, 102221, 103123, 103124, 103131, 100163, 100306, 100309, 103300, 101099, 101100, 101101, 103265, 100422, 103019, 103331, 103362, 103393, 103402, 103419, 103252, 103261, 103267, 103269, 103270, 103276, 103277, 103280, 103281, 103022, 103381, 103194 103145, 103148, 103152, 100345, 102183, 103345, 103368, 103415, 103416, 103245, 103249, 103250, 103264, 103080, 103082, 103086, 103088, 103089, 103090, 100231, 103431, 103306, 103341, 103114, 100070, 100071, 100074, 102155, 102157, 103040, 103042, 103039, 102174, 102182, 103130, 103200, 103234, 103116, 103117, 103119, 103288, 103008, 103216, 103465, 103189, 103208, 102010, 102295, 102296, 102302, 100006, 100005, 103352, 103283, 103308, 103310, 103115, 103244, 103246, 103014, 103242, 102143, 103359, 103274, 103437 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205; Serial Numbers: 123021, 123004, 123047, 123053, 122011 ***Updated 1/18/22*** SENSIS Vibe Hemo, Serial #103185 ***Updated 2/24/22*** SENSIS Vibe Hemo Serial #103290 103510 103451 103461 103444 103450 103448 103445 103442 103449 103439 103457 SENSIS Vibe Combo Serial #123055 123056 123058 The following serial numbers have been removed from the scope of this recall: SENSIS Vibe Hemo Serial #103301 103424 ***Updated 8/5/22*** The following serial numbers have been added to the recall: SENSIS Vibe Combo Serial numbers 103307, 103312
Recalling firm:
Siemens Medical Solutions USA, Inc
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UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2021

Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an extended drip tray: Model Number: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722029, 722033, 722034, 722036, 722038, 722039. Allura Xper F010 {C+F). 722003 Allura Xper F010/10 722005 Allura Xper F020 722006 Allura Xper F020/10 and F020/20 722008 Allura Xper F010 722010 Altura Xper F010/10 722011 Allura Xper F020 722012 Allura Xper FD20 biplane 722013 Allura Xper FDlO OR Table 722014 Allura Xper FD20 OR Table 722015 Allura Xper FDl0/10 OR Table 722019 Allura Xper FD20 Biplane OR Table 722020 Allura Xper FD10 OR Table 722022 Allura Xper FD20 OR Table 722023 Allura Xper FD10/10 OR Table 722024 Altura Xper FD20 Biplane OR Table 722025 Allura Xper FD10 722026 Allura Xper FD10/10 722027 Altura Xper FD20/10 biplane 722029 Allura Xper FD10 OR Table 722033 Allura Xper FD10/10 OR Table 722034 Allura Xper FD20/10 OR Table 722036 Allure Xper F020/20 722038 Altura Xper FD20/20 biplane OR Table 722039

Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.

ALL 50 STATES
Full report

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

Recall #:
89375
Lot/product code:
Allura Xper FD10 722003/722026  (US) S/N:  24 40 71 162 191 266 283 294 319 347 406 485 825 959 965 967 985 990 1246 1353 1444 1944 1949 UDI: (01)00884838054189(21)825 (01)00884838054189(21)967 (01)00884838054189(21)1246 (01)00884838054189(21)965 (01)00884838054189(21)959 (01)00884838054189(21)990 (01)00884838054189(21)985   Allura Xper FD10/10 722005 S/N: 144 US OUS: 37 52 74 79 80 108 279 417 459  Allura Xper FD20 722006 S/N: US 44 72 234 246 263 268 327 333 429 469 471 498 514 535 550 554 588 604 718 754 766 861 1174 1274 1355 1400 1783 1831 1844 1878 1886 1931 2018 UDI: (01)00884838054202(21)893  OUS: 11 40 89 102 112 125 151 244 364 408 431 484 568 580 594 597 602 640 643 704 811 940 971 1262 1312 1402 1405 1424 1465 1481 1658 1691 1794 1796 1815 1852 1859 1879 1891 1948 1959 1974 1985 1988 2141 2311 2521 2554   Allura Xper FD20 Biplane 722008 S/N: 33, 82, 374 (US) OUS: 39 86 224 249 336 384 388 532   Allura Xper FD10 722010 S/N:OUS 163 340 1422 1429 1434  Allura Xper FD20 722012 S/N: OUS 395 463 927 1013 1518 2652 2854 2918  Allura Xper FD20 OR Table 722015 S/N: 30 (OUS)  Allura Xper FD10 722026 S/N OUS: 315 701 748 884 888 943 948 960 971 975 978 984 989 995  Allura Xper FD10/10 722027 S/N: OUS 268 278  Allura Xper FD20/10 722029 S/N:OUS 9  Allura Xper FD10 722026 S/N : US 825 959 965 967 985 990 1246  OUS: 11 40 89 102 112 125 151 244 364 408 431 484 568 580 594 597 602 640 643 704 811 940 971 1262 1312 1402 1405 1424 1465 1481 1658 1691 1794 1796 1815 1852 1859 1879 1891 1948 1959 1974 1985 1988 2141 2311 2521 2554  Allura Xper FD10/10 266 722027 S/N: 266  Allura Xper FD20 722028 S/N: 893 UDI: (01)00884838054202(21)893  Allura Xper FD20/10 722029 S/N: 91, 94 US UDI: (01)00884838054219(21)94 OUS:  S/N:6
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2021

Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray: Model Number: 722031

Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.

ALL 50 STATES
Full report

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

Recall #:
89375
Lot/product code:
S/N: OUS 109
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2021

Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable instruments required for implanting the Triathlon Globalization Implant System for individual patients receiving primary total knee arthroplasty (TKA). Catalog# 6541-9-109

Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemented Keel Punch (P/N: 6541-2-013Y) instrument can lead to delay in surgery or if used could lead to unintended bone preparation

ALL 50 STATES
Full report

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

Recall #:
89190
Lot/product code:
Lots #: 0552101A596, 0552101A602 GTIN#: 07613327461503
Recalling firm:
Howmedica Osteonics Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2021

DBB-06 Hemodialysis Delivery System

Device lacks premarket approval.

ALL 50 STATES
Full report

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

Recall #:
88641
Lot/product code:
Model Number: DBB-06; Serial Numbers: J1910861, J1905670, J1905916, J1910971, J1909943, J1909306, J1908111, J1909202, J1907127, J1908023, J1910962, J1910866, J1910028, J1909307, J1907329, J1909853, J1908776, J1908108, J1914585, J1908762, J1909020, J1908872, J1908439, J1908777, J1910867, J1911026, J1907034, J1911033, J1908665, J1909209, J1909705, J1906923, J1911029, J1910870, J1910967, J1911040, J1910499, J1905788, J1910558, J1909689, J1910498, J1909315, J1909662, J1906052, J1910692, J1909412, J1908116, J1910688, J1908582, J1908657, J1909017, J1908281, J1908581, J1909012, J1908660, J1907321, J1907123, J1907317, J1911036, J1905580, J1911354, J1911217, J1907939, J1911035, J1908584, J1911039, J1906050, J1910494, J1909850, J1910560, J1908020, J1908115, J1907932, J1908118, J1910774, J1905789, J1905576, J1909116, J1910489, J1909312, J1908435, J1905791, J1905921, J1910116, J1910027, J1909407, J1909406, J1910491, J1909405, J1909952, J1910495, J1910023, J1909947, J1909945, J1909690, J1910296, J1910300, J1910112, J1910030, J1909414, J1909308, J1909942, J1909313, J1910118, J1905793, J1910690, J1905920, J1910686, J1910400, J1911038, J1910297, J1910115, J1910406, J1905927, J1910136, J1908417, J1908778, J1908034, J1907320, J1909122, J1908114, J1907116, J1908664, J1906921, J1908112, J1908870, J1908757, J1908120, J1908570, J1908291, J1907937, J1908441, J1908583, J1908658, J1908024, J1909022, J1908030, J1908770, J1909204, J1908285, J1907931, J1910862, J1908866, J1908426, J1908774, J1908033, J1908113, J1908750, J1906826, J1907119, J1909021, J1907122, J1908773, J1908659, J1908771, J1909200, J1909199, J1908779, J1909011, J1908571, J1909117, J1906927, J1910860, J1911223, J1911352, J1905787, J1905926, J1910969, J1909708, J1905799, J1911220, J1910562, J1910864, J1908025, J1907926, J1909109, J1909119, J1908751, J1908412, J1907106, J1909024, J1907033, J1908662, J1911115, J1914588, J1911222, J1905800, J1910857, J1910488, J1905795, J1905919, J1908752, J1910402, J1914584, J1905667, J1910869, J1908424, J1905918, J1905575, J1905798, J1908760, J1905579, J1910685, J1910691, J1911114, J1905923, J1908572, J1905922, J1905578, J1905581, J1905928, J1911027, J1911216, J1905584, J1911221, J1905666, J1911218, J1910868, J1905660, J1905582, J1905674, J1910687, J1908022, J1909208, J1909120, J1908107, J1910856, J1910779, J1910564, J1910863, J1905577, J1905930, J1909110, J1905801, J1908109, J1908768, J1911219, J1910694, J1906055, J1908772, J1914587, J1906053, J1911357, J1909304, J1908871, J1908663, J1908289, J1907126, J1908661, J1908294, J1908575, J1908769, J1905668, J1909305, J1909196, J1908578, J1909197, J1909195, J1908754, J1908117, J1909015, J1908026, J1909013, J1907105, J1906825, J1909112, J1908758, J1909206, J1910563, J1910775, J1909121, J1909203, J1907453, J1909111, J1907328, J1908867, J1908414, J1908775, J1911350, J1908761, J1909114, J1907928, J1907933, J1908416, J1908428, J1908437, J1908865, J1909019, J1909123, J1906926, J1907936, J1908749, J1908763, J1909115, J1909118, J1908110, J1908421, J1908580, J1908874, J1909207, J1908579, J1909302, J1908415, J1908873, J1907109, J1907318, J1907454, J1907927, J1907929, J1908021, J1908119, J1908280, J1908282, J1908423, J1908429, J1908442, J1908577, J1908651, J1908753, J1908759, J1909010, J1907128, J1907935, J1908031, J1908780, J1909014, J1906827, J1906830, J1907930, J1906829, J1906924, J1906925, J1906930, J1907029, J1907035, J1907037, J1907315, J1907324, J1907925, J1907938, J1908027, J1908028, J1908029, J1908032, J1908290, J1908419, J1908420, J1908430, J1908433, J1908436, J1908438, J1908440, J1908574, J1908576, J1908655, J1908781, J1908868, J1909016, J1909018, J1909023, J1909113, J1909198, J1906831, J1906834, J1907038, J1907117, J1907118, J1907124, J1908283, J1908284, J1908286, J1908413, J1908425, J1908432, J1908434, J1908652, J1908869, J1907125, J1908293, J1908418, J1908431, J1908573, J1908654, J1907326, J1908422, J1908653, J1907120, J1907325, J1908292, J1906838, J1906118, J1906400, J1906784, J1906824, J1906828, J1906835, J1906836, J1906928, J1906108, J1906121, J1906291, J1906404, J1906779, J1906780, J1906781, J1906782, J1906110, J1906113, J1906832, J1906931, J1906932, J1906933, J1906411, J1906109, J1906117, J1906282, J1906287, J1906405, J1906407, J1906409, J1906281, J1906286, J1906289, J1906292, J1906293, J1906294, J1906408, J1906116, J1906280, J1906283, J1906403, J1906783, J1907114, J1906929, J1907031, J1907032, J1907036, J1907115, J1907455, J1906833, J1906920, J1906934, J1907108, J1907322, J1907323, J1906107, J1906837, J1906922, J1907030, J1907121, J1907319, J1906778, J1906511, J1906663, J1906664, J1906667, J1906668, J1906669, J1906671, J1906672, J1906673, J1906675, J1906677, J1907458, J1907459, J1907460, J1907463, J1907464, J1907465, J1907466, J1907624, J1907625, J1907628, J1907630, J1907631, J1907633, J1907636, J1907637, J1907711, J1907712, J1907713, J1907714, J1907715, J1907716, J1907717, J1907719, J1907720, J1907722, J1907723, J1906410, J1906509, J1906510, J1906666, J1906670, J1906674, J1906770, J1… (truncated, 7846 characters total — see the official FDA record for the full value)
Recalling firm:
Nikkiso Ltd - Shizuoka Plant
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 26, 2021

Infa-Therm Transport Mattress, Reference Number 989805616831 1015

After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

ALL 50 STATES
Full report

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

Recall #:
89173
Lot/product code:
All units are impacted
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 29, 2021

Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T

After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

ALL 50 STATES
Full report

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

Recall #:
89163
Lot/product code:
All units are impacted
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 29, 2021

Medichoice Infant Heel Warmer, Reference # 989805643721 1079906

After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

ALL 50 STATES
Full report

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

Recall #:
89163
Lot/product code:
All units are impacted
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 29, 2021

Heel Snuggler, Reference # 989805603411 99047

After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

ALL 50 STATES
Full report

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

Recall #:
89163
Lot/product code:
All units are impacted
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 29, 2021

Infant Heel Warmers w/strap, Reference # 989805603201 1223

After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

ALL 50 STATES
Full report

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

Recall #:
89163
Lot/product code:
All units are impacted
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 30, 2021

Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64

Stronger than it should be Drug: Minimally stronger than it should be

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-0296-2022
Lot/product code:
Lot #: 15594, Exp Date 05/2023
Recalling firm:
Teligent Pharma, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 30, 2021

activforce 2 package labeling: Model: Activ5-M R 201-200563

Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. 2) Firm failing to register and list its medical devices with U.S. Food and Drug Administration.

Full report

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

Recall #:
89070
Lot/product code:
Activforce 2 Serial Numbers: 5M1011012046AK7655 5M1011012046AK7556 5M1011012046AK7557 5M1011012046AK7559 5M1011012046AK7560 5M1011012046AK7561 5M1011012046AK7562 5M1011012046AK7563 5M1011012046AK7564 5M1011012046AK7565 5M1011012046AK7566 5M1011012046AK7567 5M1011012046AK7568 5M1011012046AK7569 5M1011012046AK7570 5M1011012046AK7571 5M1011012046AK7572 5M1011012046AK7573 5M1011012046AK7574 5M1011012046AK7575 5M1011012046AK7576 5M1011012046AK7577 5M1011012046AK7578 5M1011012046AK7579 5M1011012046AK7580 5M1011012046AK7581 5M1011012046AK7582 5M1011012046AK7583 5M1011012046AK7584 5M1011012046AK7585 5M1011012046AK7586 5M1011012046AK7587 5M1011012046AK7588 5M1011012046AK7589 5M1011012046AK7590 5M1011012046AK7591 5M1011012046AK7592 5M1011012046AK7593 5M1011012046AK7594 5M1011012046AK7595 5M1011012046AK7596 5M1011012046AK7597 5M1011012046AK7598 5M1011012046AK7599 5M1011012046AK7600 5M1011012046AK7601 5M1011012046AK7602 5M1011012046AK7603 5M1011012046AK7604 5M1011012046AK7605 5M1011012046AK7606 5M1011012046AK7607 5M1011012046AK7608 5M1011012046AK7609 5M1011012046AK7610 5M1011012046AK7611 5M1011012046AK7612 5M1011012046AK7613 5M1011012046AK7614 5M1011012046AK7615 5M1011012046AK7616 5M1011012046AK7617 5M1011012046AK7618 5M1011012046AK7619 5M1011012046AK7620 5M1011012046AK7621 5M1011012046AK7622 5M1011012046AK7623 5M1011012046AK7624 5M1011012046AK7625 5M1011012046AK7626 5M1011012046AK7627 5M1011012046AK7628 5M1011012046AK7629 5M1011012046AK7630 5M1011012046AK7631 5M1011012046AK7632 5M1011012046AK7633 5M1011012046AK7634 5M1011012046AK7635 5M1011012046AK7636 5M1011012046AK7637 5M1011012046AK7638 5M1011012046AK7639 5M1011012046AK7640 5M1011012046AK7641 5M1011012046AK7642 5M1011012046AK7643 5M1011012046AK7644 5M1011012046AK7645 5M1011012046AK7646 5M1011012046AK7647 5M1011012046AK7648 5M1011012046AK7649 5M1011012046AK7650 5M1011012046AK7651 5M1011012046AK7652 5M1011012046AK7653 5M1011012046AK7654 5M1011012102AL7776 5M1011012102AL7777 5M1011012102AL7778 5M1011012102AL7779 5M1011012102AL7780 5M1011012102AL7781 5M1011012102AL7783 5M1011012102AL7784 5M1011012102AL7785 5M1011012102AL7786 5M1011012102AL7787 5M1011012102AL7788 5M1011012102AL7789 5M1011012102AL7790 5M1011012102AL7791 5M1011012102AL7792 5M1011012102AL7793 5M1011012102AL7794 5M1011012102AL7795 5M1011012102AL7796 5M1011012102AL7797 5M1011012102AL7798 5M1011012102AL7799 5M1011012102AL7800 5M1011012102AL7801 5M1011012102AL7802 5M1011012102AL7803 5M1011012102AL7804 5M1011012102AL7805 5M1011012102AL7806 5M1011012102AL7807 5M1011012102AL7808 5M1011012102AL7809 5M1011012102AL7810 5M1011012102AL7811 5M1011012102AL7812 5M1011012102AL7813 5M1011012102AL7814 5M1011012102AL7815 5M1011012102AL7816 5M1011012102AL7817 5M1011012102AL7818 5M1011012102AL7819 5M1011012102AL7820 5M1011012102AL7821 5M1011012102AL7822 5M1011012102AL7823 5M1011012102AL7824 5M1011012102AL7825 5M1011012102AL7826 5M1011012102AL7827 5M1011012102AL7828 5M1011012102AL7829 5M1011012102AL7830 5M1011012102AL7831 5M1011012102AL7832 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5M1011012102AL7885 5M1011012102AL7886 5M1011012102AL7887 5M1011012102AL7888 5M1011012102AL7889 5M1011012102AL7890 5M1011012102AL7891 5M1011012102AL7892 5M1011012102AL7893 5M1011012102AL7894 5M1011012102AL7895 5M1011012102AL7896 5M1011012102AL7897 5M1011012102AL7898 5M1011012102AL7899 5M1011012102AL7900 5M1011012102AL7901 5M1011012102AL7902 5M1011012102AL7903 5M1011012102AL7904 5M1011012102AL7905 5M1011012102AL7906 5M1011012102AL7907 5M1011012102AL7908 5M1011012102AL7909 5M1011012102AL7910 5M1011012102AL7911 5M1011012102AL7912 5M1011012102AL7913 5M1011012102AL7914 5M1011012102AL7915 5M1011012102AL7916 5M1011012102AL7917 5M1011012102AL7918 5M1011012102AL7919 5M1011012102AL7920 5M1011012102AL7921 5M1011012102AL7922 5M1011012102AL7923 5M1011012102AL7924 5M1011012102AL7925 5M1011012102AL7926 5M1011012102AL7927 5M1011012102AL7928 5M1011012102AL7929 5M1011012102AL7930 5M1011012102AL7931 5M1011012102AL7932 5M1011012102AL7933 5M1011012102AL7934 5M1011012102AL7935 5M1011012102AL7936 5M1011012102AL7937 5M1011012102AL7938 5M1011012102… (truncated, 150280 characters total — see the official FDA record for the full value)
Recalling firm:
Activbody, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 30, 2021

Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual: ACTIV5 USER MANUAL Welcome to Activ5, the first isometrics-based smart strength training and rehabilitation device.

Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. 2) Firm failing to register and list its medical devices with U.S. Food and Drug Administration.

Full report

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

Recall #:
89070
Lot/product code:
Activforce Kit Number: AB0000-AC5540 Serial Numbers: 5P1011011708AB0000 5P1011011708AB0001 5P1011011708AB0002 5P1011011708AB0003 5P1011011708AB0004 5P1011011708AB0005 5P1011011708AB0006 5P1011011708AB0007 5P1011011708AB0008 5P1011011708AB0009 5P1011011708AB0010 5P1011011708AB0011 5P1011011708AB0012 5P1011011708AB0013 5P1011011708AB0014 5P1011011708AB0015 5P1011011708AB0016 5P1011011708AB0017 5P1011011708AB0018 5P1011011708AB0019 5P1011011708AB0020 5P1011011708AB0021 5P1011011708AB0022 5P1011011708AB0023 5P1011011708AB0024 5P1011011708AB0025 5P1011011708AB0026 5P1011011708AB0027 5P1011011708AB0028 5P1011011708AB0029 5P1011011708AB0030 5P1011011708AB0031 5P1011011708AB0032 5P1011011708AB0033 5P1011011708AB0034 5P1011011708AB0035 5P1011011708AB0036 5P1011011708AB0037 5P1011011708AB0038 5P1011011708AB0039 5P1011011708AB0040 5P1011011708AB0041 5P1011011708AB0042 5P1011011708AB0043 5P1011011708AB0044 5P1011011708AB0045 5P1011011708AB0046 5P1011011708AB0047 5P1011011708AB0048 5P1011011708AB0049 5P1011011708AB0050 5P1011011708AB0051 5P1011011708AB0052 5P1011011708AB0053 5P1011011708AB0054 5P1011011708AB0055 5P1011011708AB0056 5P1011011708AB0057 5P1011011708AB0058 5P1011011708AB0059 5P1011011708AB0060 5P1011011708AB0061 5P1011011708AB0062 5P1011011708AB0063 5P1011011708AB0064 5P1011011708AB0065 5P1011011708AB0066 5P1011011708AB0067 5P1011011708AB0068 5P1011011708AB0069 5P1011011708AB0070 5P1011011708AB0071 5P1011011708AB0072 5P1011011708AB0073 5P1011011708AB0074 5P1011011708AB0075 5P1011011708AB0076 5P1011011708AB0077 5P1011011708AB0078 5P1011011708AB0079 5P1011011708AB0080 5P1011011708AB0081 5P1011011708AB0082 5P1011011708AB0083 5P1011011708AB0084 5P1011011708AB0085 5P1011011708AB0086 5P1011011708AB0087 5P1011011708AB0088 5P1011011708AB0089 5P1011011708AB0090 5P1011011708AB0091 5P1011011708AB0092 5P1011011708AB0093 5P1011011708AB0094 5P1011011708AB0095 5P1011011708AB0096 5P1011011708AB0097 5P1011011708AB0098 5P1011011708AB0099 5P1011011708AB0100 5P1011011708AB0101 5P1011011708AB0102 5P1011011708AB0103 5P1011011708AB0104 5P1011011708AB0105 5P1011011708AB0106 5P1011011708AB0107 5P1011011708AB0108 5P1011011708AB0109 5P1011011708AB0110 5P1011011708AB0111 5P1011011708AB0112 5P1011011708AB0113 5P1011011708AB0114 5P1011011708AB0115 5P1011011708AB0116 5P1011011708AB0117 5P1011011708AB0118 5P1011011708AB0119 5P1011011708AB0120 5P1011011708AB0121 5P1011011708AB0122 5P1011011708AB0123 5P1011011708AB0124 5P1011011708AB0125 5P1011011708AB0126 5P1011011708AB0127 5P1011011708AB0128 5P1011011708AB0129 5P1011011708AB0130 5P1011011708AB0131 5P1011011708AB0132 5P1011011708AB0133 5P1011011708AB0134 5P1011011708AB0135 5P1011011708AB0136 5P1011011708AB0137 5P1011011708AB0138 5P1011011708AB0139 5P1011011708AB0140 5P1011011708AB0141 5P1011011708AB0142 5P1011011708AB0143 5P1011011708AB0144 5P1011011708AB0145 5P1011011708AB0146 5P1011011708AB0147 5P1011011708AB0148 5P1011011708AB0149 5P1011011708AB0150 5P1011011708AB0151 5P1011011708AB0152 5P1011011708AB0153 5P1011011708AB0154 5P1011011708AB0155 5P1011011708AB0156 5P1011011708AB0157 5P1011011708AB0158 5P1011011708AB0159 5P1011011708AB0160 5P1011011708AB0161 5P1011011708AB0162 5P1011011708AB0163 5P1011011708AB0164 5P1011011708AB0165 5P1011011708AB0166 5P1011011708AB0167 5P1011011708AB0168 5P1011011708AB0169 5P1011011708AB0170 5P1011011708AB0171 5P1011011708AB0172 5P1011011708AB0173 5P1011011708AB0174 5P1011011708AB0175 5P1011011708AB0176 5P1011011708AB0177 5P1011011708AB0178 5P1011011708AB0179 5P1011011708AB0180 5P1011011708AB0181 5P1011011708AB0182 5P1011011708AB0183 5P1011011708AB0184 5P1011011708AB0185 5P1011011708AB0186 5P1011011708AB0187 5P1011011708AB0188 5P1011011708AB0189 5P1011011708AB0190 5P1011011708AB0191 5P1011011708AB0192 5P1011011708AB0193 5P1011011708AB0194 5P1011011708AB0195 5P1011011708AB0196 5P1011011708AB0197 5P1011011708AB0198 5P1011011708AB0199 5P1011011708AB0200 5P1011011708AB0201 5P1011011708AB0202 5P1011011708AB0203 5P1011011708AB0204 5P1011011708AB0205 5P1011011708AB0206 5P1011011708AB0207 5P1011011708AB0208 5P1011011708AB0209 5P1011011708AB0210 5P1011011708AB0211 5P1011011708AB0212 5P1011011708AB0213 5P1011011708AB0214 5P1011011708AB0215 5P1011011708AB0216 5P1011011708AB0217 5P1011011708AB0218 5P1011011708AB0219 5P1011011708AB0220 5P1011011708AB0221 5P1011011708AB0222 5P1011011708AB0223 5P1011011708AB0224 5P1011011708AB0225 5P1011011708AB0226 5P1011011708AB0227 5P1011011708AB0228 5P1011011708AB0229 5P1011011708AB0230 5P1011011708AB0231 5P1011011708AB0232 5P1011011708AB0233 5P1011011708AB0234 5P1011011708AB0235 5P1011011708AB0236 5P1011011708AB0237 5P1011011708AB0238 5P1011011708AB0239 5P1011011708AB0240 5P1011011708AB0241 5P1011011708AB0242 5P1011011708AB0243 5P1011011708AB0244 5P1011011708AB0245 5P1011011708AB0246 5P1011011708AB0247 5P1011011708AB0248 5P1011011708AB0249 5P1011011708AB0250 5P1011011708AB0251 5P1011011708AB0252 5P1011011708AB0253 5P1011011708AB0254 5P1011011708AB0255 5P1011011708AB0256 5P1011011708AB0257 5P1011011708AB0258 5P1011011708AB0259 5P10110… (truncated, 295331 characters total — see the official FDA record for the full value)
Recalling firm:
Activbody, Inc.
View official FDA record (opens in a new tab)