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Recalls affecting Kentucky

Data last updated: September 10, 2026 at 1:16 PM UTC

16,694 recalls found

Just announced

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

Business Pill, Branch Manager for Mendietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

B. Braun0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

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

Little TemptationsChocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

KofinasGarlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything SproutsRobust Radish Mix, 5oz Cups

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

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled February 22, 2021

Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2. p/n 115-034414-00 and 115-034413-00 when used with the following software versions: 03.04.00 04.01.00 04.03.00 04.04.00 04.04.01

BeneVision DMS may intermittently freeze and require a manual reboot after which normal operation resumes. If a freeze occur, patients monitored on a telemetry transmitter will no longer communicate data to the BeneVision DMS

ALL 50 STATES
Full report

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

Recall #:
87380
Lot/product code:
Serial Numbers: EHT92003259 EHL5A000498 EHL61000561 EHL67000842 EHL67000843 EHM67000809 EHT04004409 EHT04004412 EHT0A004549 EHT94003329 EHT94003338 EHT94003342 EHT96003496 EHT9C003918 EHT9C003920 EHL64000627 EHL64000629 EHL64000622 EHL65000697 EHL6B001060 EHL6B001063 EHL6B001069 EHM6C001164 EHL74001282 EHM86002739 EHL5B000545 EHL78001536 EHT07004512 EHT8A002987 EHT02004001 EHT87002783 EHT87002784 EHL5A000463 EHT04004422 EHT92003257 EHL65000729 EHM69000971 EHT89002847 EHT89002850 EHT89002860 EHT87002781 EHL75001349 EHM74001293 EHM75001343 EHL74001301 EHL78001509 EHM69000970 EHT0A004556 EHT8A002980 EHL5A000532 EHM67000801 EHT91003190 EHT99003784 EHL73001200 EHL73001205 EHL73001207 EHT94003326 EHL79001585 EHM7B001731 EHL5A000526 EHL5B000543 EHL65000717 EHL65000721 EHT96003499 EHT88002799 EHT94003339 EHT96003503 EHT9C003922 EHL83002385 EHL81002225 EHL83002304 EHL83002310 EHL74001311 EHL83002387 EHL67000845 EHL73001197 EHL73001198 EHL73001199 EHM67000777 EHM68000887 EHT91003180 EHT91003181 EHT96003500 EHL84002434 EHT06004482 EHL68000900 EHT89002851 EHT89002853 EHT89002855 EHT89002861 EHT04004425 EHT04004410 EHL59000404 EHT92003244 EHL59000382 EHL5B000546 EHL5B000547 EHL65000704 EHL69000931 EHL72001179 EHL77001466 EHT8C003065 EHT8C003066 EHT8C003068 EHT07004496 EHT07004505 EHT88002796 EHL77001469 EHT91003182 EHT91003183 EHT96003540 EHT92003245 EHT92003250 EHT92003251 EHL76001382 EHL79001605 EHL6C001118 EHL65000727 EHL74001312 EHM68000895 EHM68000910 EHT97003624 EHT99003779 EHT99003780 EHL83002405 EHT88002786 EHT94003337 EHL76001383 EHL76001386 EHL76001390 EHL76001392 EHL77001481 EHL77001482 EHL77001483 EHL77001484 EHM74001273 EHM74001297 EHM76001377 EHM76001378 EHL5A000490 EHL5A000496 EHT06004490 EHL67000827 EHT8C003052 EHL73001225 EHL73001231 EHM6A001051 EHM6A001053 EHM6C001096 EHM77001488 EHL84002433 EHL81002219 EHL83002297 EHL83002298 EHL73001209 EHM78001517 EHM68000886 EHL68000902 EHL62000584 EHL61000566 EHL7A001641 EHM7A001666 EHL5A000458 EHL5A000534 EHL81002222 EHL76001387 EHL7A001690 EHL65000723 EHT85002591 EHL74001299 EHT94003336 EHL64000620 EHL64000621 EHL64000623 EHL64000625 EHL64000626 EHL64000638 EHL76001418 EHL76001421 EHL76001423 EHM7B001733 EHL81002227 EHT86002720 EHT86002721 EHT86002723 EHT86002728 EHT88002788 EHT0A004540 EHL79001546 EHL79001602 EHM78001516 EHM7A001686 EHL81002230 EHT96003542 EHL74001314 EHT04004421 EHT04004462 EHT04004469 EHT04004416 EHT04004417 EHL7B001746 EHL7C001758 EHL65000694 EHT0A004541 EHL67000825 EHL67000826 EHL67000828 EHL67000833 EHL67000834 EHL68000903 EHL68000904 EHL68000905 EHL68000906 EHL68000908 EHT96003541 EHT99003785 EHL72001189 EHT04004419 EHL63000595 EHL67000846 EHL6A001014 EHL6C001110 EHM67000808 EHM68000890 EHM68000891 EHT0A004550 EHL6A001039 EHL73001227 EHL73001229 EHL73001230 EHL73001232 EHM69000924 EHM69000926 EHM6A001052 EHM6A001054 EHM6C001093 EHM6C001094 EHL79001545 EHL79001547 EHM77001491 EHM7C001770 EHL7A001650 EHL6A001035 EHM68000894 EHL65000699 EHL7B001747 EHL83002407 EHL84002435 EHM81002042 EHM86002738 EHT04004418 EHT87002763 EHT88002806 EHL83002390 EHL83002392 EHL5A000486 EHL5A000516 EHL62000575 EHL62000582 EHL63000596 EHL63000598 EHL63000600 EHL63000601 EHL63000602 EHL67000832 EHM68000888 EHM68000914 EHL75001348 EHL81002226 EHM75001330 EHT06004488 EHM74001298 EHL79001544 EHT92003242 EHT96003501 EHT9C003919 EHT8C003062 EHL5A000478 EHL5A000484 EHT04004413 EHT8A002979 EHT8A002981 EHT89002849 EHL7C001762 EHL7C001917 EHT8C003060 EHT0A004559 EHT85002581 EHT85002583 EHT95003468 EHL65000751 EHL69000929 EHL6B001071 EHL6B001072 EHM68000916 EHT92003249 EHT94003335 EHL77001467 EHL5A000520 EHL5A000525 EHM74001272 EHM74001318 EHL6A001034 EHL83002299 EHT0A004560 EHL7C001761 EHL84002439 EHT86002732 EHL7A001649 EHL7A001652 EHM7B001736 EHM7B001740 EHL77001465 EHL77001473 EHM95003470 EHM96003571 EHL83002389 EHL75001358 EHM74001292 EHL5A000497 EHL5A000514 EHL62000570 EHL5A000528 EHL75001360 EHM75001344 EHT03004115 EHT8C003049 EHT06004487 EHL76001417 EHT99003823 EHL59000403 EHL59000406 EHL59000408 EHL7A001658 EHM81002039 EHL5B000542 EHL6A001001 EHT92003248 EHL75001357 EHL78001535 EHL78001537 EHL78001538 EHT04004467 EHT8C003050 EHT96003533 EHT96003543 EHL7A001700 EHT99003824 EHL67000824 EHM68000912 EHT95003469 EHL73001208 EHM75001338 EHT88002797 EHT8A002986 EHL83002309 EHT94003332 EHL7A001692 EHT88002812 EHT96003532 EHT88002814 EHT88002809 EHT99003783 EHL74001321 EHL74001326 EHM74001270 EHT9C003921 EHL7A001696 EHT92003247 EHL74001309 EHL75001350 EHL5A000523 EHL59000366 EHL59000374 EHL59000383 EHL5A000521 EHM74001294 EHL5A000466 EHL74001302 EHL74001306 EHL75001356 EHM74001289 EHL79001604 EHM7A001687 EHT88002791 EHL7A001699 EHL7C001921 EHL83002403 EHM6A001043 EHL67000822 EHL67000831 EHM67000810 EHM69000952 EHM69000954 EHM69000955 EHM69000956 EHT88002787 EHL5A000480 EHT9C003926 EHT9C003927 EHL78001512 EHM78001515 EHL63000617 EHT06004483 EHL59000409 EHL7C001760 EHM85002683 EHL7C001759 EHL7C001904 EHM76001372 EHT03004116 EHT03004117 EHL61000562 EHL78001510 EHM75001332 EHM7… (truncated, 13660 characters total — see the official FDA record for the full value)
Recalling firm:
Mindray DS USA, Inc. dba Mindray North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 26, 2021

Medtronic REF: MMT-7020D3 Guardian Sensor (3) for the following packaging: GS3 1 PK OUS3/ GTIN: 00643169704121 GS3 1PK 9L OUS3/ GTIN: 00763000318895 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.

Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.

ALL 50 STATES
Full report

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

Recall #:
87476
Lot/product code:
All Lot numbers within active shelf life
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 26, 2021

Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: GS3 1PK 2L US/GTIN: 00763000140779 GS3 1PK 2L US/ GTIN: 00763000337049 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.

Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.

ALL 50 STATES
Full report

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

Recall #:
87476
Lot/product code:
All Lot numbers within active shelf life
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 26, 2021

BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.

The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate intervention to remove the capsule is required. Potential outcomes following capsule aspiration include low oxygen saturation, intervention to retrieve the capsule, potential need to intubate the patient, extended hospital stay and a delay of treatment. Thirteen reports of capsule aspiration have been received the last 2 years.

ALL 50 STATES
Full report

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

Recall #:
87396
Lot/product code:
49349Q 49350Q 49351Q 49352Q 49799Q 49800Q 49801Q 49802Q 49809Q 49849Q 49850Q 49851Q 50392Q 50393Q 50492Q 50493Q 50494Q 50495Q 50496Q 50497Q 50615Q 50616Q 50868Q 50869Q 50870Q 50871Q 50872Q 50873Q 50874Q 50875Q 50876Q 50877Q 50878Q 50879Q 50880Q 50881Q
Recalling firm:
Covidien Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 26, 2021

Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing.

There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results.

ALL 50 STATES
Full report

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

Recall #:
87557
Lot/product code:
Part No. (PN) FAB-15004 (Box Lot Number)/Catalog No PRD-0400 (Box/Tray Lot Number)  285762 / 647288, 285765 / 647288, 286025 / 648958, 286026 / 648958, 286028 / 648959, 286852 / 650655, 287410 / 650656, 289297 / 648959, 290057 / 647288, 290068/654833, 290409 / 654833, 291425 / 657545
Recalling firm:
Hologic, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 26, 2021

CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.

The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate intervention to remove the capsule is required. Potential outcomes following capsule aspiration include low oxygen saturation, intervention to retrieve the capsule, potential need to intubate the patient, extended hospital stay and a delay of treatment. Thirteen reports of capsule aspiration have been received the last 2 years.

ALL 50 STATES
Full report

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

Recall #:
87396
Lot/product code:
46966F 47358F 47359F 47360F 47361F 47362F 47363F 47364F 47365F 47366F 47367F 47368F 47369F 47370F 47371F 47783F 48082F 48083F 48084F 48085F 48086F 48087F 48088F 48090F 48091F 48092F 48437F 48438F 48439F 48440F 48441F 48442F 48443F 48444F 48445F 48446F 48447F 48448F 48449F 48781F 48782F 48783F 49068F 49069F 49070F 49071F 49072F 49073F 49074F 49075F 49076F 49077F 49078F 49079F 49080F 49081F 49082F 49083F 49084F 49366F 49367F 49368F 49369F 49370F 49371F 49372F 49373F 49374F 49375F 49376F 49377F 49378F 49379F 49380F 49381F 49382F 49383F 49384F 49385F 49386F 49387F 49388F 49663F 49664F 49665F 49666F 49667F 49668F 49911F 49912F 49913F 49914F 50197F 50198F 50199F 50285F 50286F 50287F 50297F 50298F 50299F 50300F 50301F 50370F 50371F 50372F 50374F 50375F 50376F 50377F 50378F 50379F 50380F 50489F 50490F 50595F 50596F 50597F 50598F 50599F 50600F 50601F 50602F 50603F 50604F 50605F 50606F 50607F 50608F 50609F 50610F 50848F 50849F 50850F 50851F 50852F 50853F 50854F 51184F 51185F 51186F 51187F 51188F 51190F
Recalling firm:
Covidien Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 26, 2021

Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, and 1420JP. Heartware HVAD controller AC adapter Models 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, and 1430US. Heartware HVAD controller DC Adapter Model 1440. Heartware HVAD data cable - monitor Model 1575. Heartware HVAD battery pack Models 1650, 1650CA-CLIN, and 1650DE. Heartware HVAD patient pack Model 1475. Heartware HVAD waist pack Models 2050, 2050IL, and 2050US. Heartware HVAD shoulder pack Models 2060, 2060IL, and 2060US.

IFU and Patient Manual updated to describe Expected Alarm Duration. The Instructions for Use (IFU) is being updated to advise clinicians that alarms that resolve after a very short period may mean there is an intermittent problem and the cause of the alarm can be evaluated by analysis of the controller log files. The Patient Manual (PM) is being updated to instruct patients to contact their clinicians if they cannot identify an alarm before it is cleared as it might mean there is an intermittent problem. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87604

ALL 50 STATES
Full report

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

Recall #:
87603
Lot/product code:
All serial numbers as of February 26, 2021. Model, GTIN: 1100, No GTIN Available; 1101, No GTIN Available; 1102, No GTIN Available; 1103, 00888707000017; 1104, No GTIN Available; 1104JP, 00888707000697; 1205, No GTIN Available; MCS1705PU, 00888707005364; 1403US, 00888707000475; 1407AU, 00888707001663; 1407CA, 00888707002851; 1407CH, 00888707001694; 1407DE, 00888707001700; 1407GB, 00888707001717; 1407IL, 00888707001724; 1407IN, 00888707001731; 1407IT, 00888707001748; 1407JP, 00888707001755; 1407KR, 00888707001762; 1420, 00888707000420; 1420JP, 00888707000437; 1430AR, 00888707000826; 1430AU, 00888707000833; 1430CA, 00888707000857; 1430CH, 00888707000871; 1430DE, 00888707000864; 1430GB, 00888707000888; 1430IL, 00888707000901; 1430IN, 00888707000505; 1430IT, 00888707000895; 1430JP, 00888707000918; 1430US, 00888707000307; 1440, 00888707001885; 1575, 00888707008051; 1650, 00888707000376; 1650CA-CLIN, 00888707001588; 1650DE, 00888707001373; 1475, 00888707008037; 2050, 00888707008082; 2050IL, 00888707001410; 2050US, 00888707000048; 2060, 00888707008099; 2060IL, 00888707001427; 2060US, 00888707000055;
Recalling firm:
Heartware, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 26, 2021

Medtronic REF: MMT-7020A, Guardian Sensor (3) for the following packaging: GS3 5PK 2L US/ GTIN: 20763000140940 GS3 5PK 2L US/ GTIN: 20763000337005 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.

Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.

ALL 50 STATES
Full report

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

Recall #:
87476
Lot/product code:
All Lot numbers within active shelf life
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 26, 2021

Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile Implant Kit, Model Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU HVAD Controller Kit, Model Numbers: 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, 1420JP HVAD AC Adapter Controller, Model Numbers: 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US HVAD DC Adapter Controller: Model Number: 1440 HVAD DATA CABLE 1575- MONITOR, Model Number: 1575 HVAD Battery Pack, Model Numbers: 1650, 1650CA-CLIN, 1650DE HeartWare Patient Pack, Model Number: 1475 HeartWare Waist Pack, Model Numbers: 2050, 2050IL, 2050OUS HeartWare Shoulder Pack, Model Numbers: 2060, 2060IL, 2060OUS The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.

Medtronic HeartWare HVAD System Instructions for Use (IFU) and Patient Manual (PM) updates regarding: Carrying Cases, Driveline Cover Orientation, and Controller Power Up Sequence issues. The PM is being updated to clarify use of the support strap and wear instructions in addition to cleaning instructions of the carrying cases. The IFU and PM are being updated to add a useful life for the carrying cases. The PM is being updated to inform users to keep the driveline cover on when disconnecting and reconnecting the driveline. The IFU and PM are being updated to clarify the power-up sequence that causes the alarm indicator LEDs and both sets of battery LEDs to turn red for 2.5 seconds while the LCD displays the power-on message. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87603 and 87604

ALL 50 STATES
Full report

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

Recall #:
87456
Lot/product code:
All serial numbers
Recalling firm:
Heartware, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 26, 2021

Medtronic REF: MMT-7020C5 Guardian Sensor (3) for the following packaging: GS3 5PK 1L AUS/ GTIN: 20763000252056 GS3 5PK 1L AUS/ GTIN: 20763000414362 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.

Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.

ALL 50 STATES
Full report

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

Recall #:
87476
Lot/product code:
All Lot numbers within active shelf life
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 26, 2021

Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, and 1420JP. Heartware HVAD controller AC adapter Models 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, and 1430US. Heartware HVAD controller DC Adapter Model 1440. Heartware HVAD data cable - monitor Model 1575. Heartware HVAD battery pack Models 1650, 1650CA-CLIN, and 1650DE. Heartware HVAD patient pack Model 1475. Heartware HVAD waist pack Models 2050, 2050IL, and 2050US. Heartware HVAD shoulder pack Models 2060, 2060IL, and 2060US.

IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling is being corrected to reflect the actual verified behavior of a successful connector to the controller, which is a "beep" and not "audible click", to clarify under what alarm conditions a beep will not be heard, and identify alternate confirmation methods (visual indicator) for successful connection. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87603

ALL 50 STATES
Full report

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

Recall #:
87604
Lot/product code:
Model, GTIN: 1100, No GTIN Available; 1101, No GTIN Available; 1102, No GTIN Available; 1103, 00888707000017; 1104, No GTIN Available; 1104JP, 00888707000697; 1205, No GTIN Available; MCS1705PU, 00888707005364; 1403US, 00888707000475; 1407AU, 00888707001663; 1407CA, 00888707002851; 1407CH, 00888707001694; 1407DE, 00888707001700; 1407GB, 00888707001717; 1407IL, 00888707001724; 1407IN, 00888707001731; 1407IT, 00888707001748; 1407JP, 00888707001755; 1407KR, 00888707001762; 1420, 00888707000420; 1420JP, 00888707000437; 1430AR, 00888707000826; 1430AU, 00888707000833; 1430CA, 00888707000857; 1430CH, 00888707000871; 1430DE, 00888707000864; 1430GB, 00888707000888; 1430IL, 00888707000901; 1430IN, 00888707000505; 1430IT, 00888707000895; 1430JP, 00888707000918; 1430US, 00888707000307; 1440, 00888707001885; 1575, 00888707008051; 1650, 00888707000376; 1650CA-CLIN, 00888707001588; 1650DE, 00888707001373; 1475, 00888707008037; 2050, 00888707008082; 2050IL, 00888707001410; 2050US, 00888707000048; 2060, 00888707008099; 2060IL, 00888707001427; 2060US, 00888707000055;
Recalling firm:
Heartware, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 26, 2021

Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging: GS3 SEMI 5PK OUS/ GTIN: 20763000192086, 5PK SF NEW GS3 OUS/GTIN: 20763000358451 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.

Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.

ALL 50 STATES
Full report

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

Recall #:
87476
Lot/product code:
All Lot numbers within active shelf life
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 26, 2021

Medtronic REF: MMT-7020LB, Guardian Sensor (3) for the following packaging: GS3 1PK US/ GTIN: 763000336998 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.

Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.

ALL 50 STATES
Full report

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

Recall #:
87476
Lot/product code:
All Lot numbers within active shelf life
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 26, 2021

Medtronic REF: MMT-7020C4 Guardian Sensor (3) for the following packaging: GS3 5PK 2L CANADA/ GTIN: 20763000179612 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.

Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.

ALL 50 STATES
Full report

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

Recall #:
87476
Lot/product code:
All Lot numbers within active shelf life
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 26, 2021

Medtronic, REF: MMT-7008D, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 1PK; GTIN: 00763000252045 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.

Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.

ALL 50 STATES
Full report

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

Recall #:
87476
Lot/product code:
All Lot numbers within active shelf life
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 26, 2021

Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 5PK 23L 1CL /GTIN: 20643169541706, ENLT PLUS 5PK 2L 1CL PR/ GTIN: 20643169786725, ENLITE PLUS 5PK 23L 1CL/ GTIN: 20763000421292 - Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.

Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.

ALL 50 STATES
Full report

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

Recall #:
87476
Lot/product code:
All Lot numbers within active shelf life
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 26, 2021

Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1511DE, 1511GB, 1511IL, 1511IN, 1511IT, 1511JP, 1511MY, 1520CLIN-AU, 1520CLIN-DE, 1520CLIN-GB, 1520JP, 1520US, 1521AU, 1521BR, 1521CA, 1521CH, 1521DE, 1521GB, 1521IL, 1521IN, 1521IT, 1521JP, 1521KR, 1521TW, 1521US, 1522CA, 1522CA-CLIN

There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the Controller ports, due to wear from misalignment of the cables to the port.

ALL 50 STATES
Full report

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

Recall #:
87446
Lot/product code:
All lot codes
Recalling firm:
Heartware, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 26, 2021

Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US 2. Medtronic HVAD Controller DC Adapter, Product Number: 1440

There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the Controller ports, due to wear from misalignment of the cables to the port.

ALL 50 STATES
Full report

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

Recall #:
87446
Lot/product code:
All lot codes
Recalling firm:
Heartware, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 26, 2021

Medtronic REF: MMT-7020C1 Guardian Sensor (3) for the following packaging: GS3 5PK OUS1/ GTIN: 20643169704071 GS3 5PK 9L OUS1/ GTIN: 20763000243320 GS3 5PK 9L OUS1/ GTIN: 20763000318844 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.

Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.

ALL 50 STATES
Full report

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

Recall #:
87476
Lot/product code:
All Lot numbers within active shelf life
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 26, 2021

Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084 GS3 1PK 9L OUS1/ GTIN: 00763000243333 GS3 1PK 9L OUS1/ GTIN: 00763000318857 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.

Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.

ALL 50 STATES
Full report

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

Recall #:
87476
Lot/product code:
All Lot numbers within active shelf life
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 26, 2021

Medtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: GS3 1PK 9L OUS2/ GTIN: 00763000243357 GS3 1PK 9L OUS2/ GTIN: 00763000318871 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.

Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.

ALL 50 STATES
Full report

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

Recall #:
87476
Lot/product code:
All Lot numbers within active shelf life
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 26, 2021

Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)10846835016277 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.

There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism

ALL 50 STATES
Full report

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

Recall #:
87440
Lot/product code:
All Lots
Recalling firm:
Biosense Webster, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 26, 2021

Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016260 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.

There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism

ALL 50 STATES
Full report

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

Recall #:
87440
Lot/product code:
All Lots
Recalling firm:
Biosense Webster, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 26, 2021

Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 1401US, 1403US, 1407AR, 1407AU, 1407BR, 1407CA, 1407CA-CLIN, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR

There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the Controller ports, due to wear from misalignment of the cables to the port.

ALL 50 STATES
Full report

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

Recall #:
87446
Lot/product code:
All lot codes
Recalling firm:
Heartware, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 26, 2021

Medtronic REF: MMT-7020LA, Guardian Sensor (3) for the following packaging: GS3 5PK US/ GTIN: 20763000336985 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.

Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.

ALL 50 STATES
Full report

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

Recall #:
87476
Lot/product code:
All Lot numbers within active shelf life
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)