BIGNOPE
Ko-fi

Recalls affecting Wyoming

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

16,268 recalls found
NewOld
High RiskLow Risk
AllClear

Just announced

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

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

Products contain undeclared yohimbine

▸Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

▸Full report
Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

▸Full report
Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

▸Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

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

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

Undeclared milk

▸Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

▸Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

▸Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

Martina — Mangoes

Potential contamination with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled February 26, 2021

Medtronic REF: MMT-7008B, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 23L 1CL / GTIN: 00643169541719 ENLITE PLUS 2L 1CL PR/ GTIN: 00643169786738 ENLITE PLUS 1PK 23L 1CL/ GTIN: 00763000421304 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-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)
UnclassifiedRisk not yet known
Medical deviceRecalled February 26, 2021

Medtronic REF: MMT-7020D5 Guardian Sensor (3) for the following packaging: GS3 1PK 1L AUS/ GTIN 00763000252069 GS3 1PK 1L AUS/ GTIN 00763000414375 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-7008C, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 5PK/ GTIN: 20763000252032 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 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-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-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

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

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

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

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-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 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

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

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-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

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-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-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

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

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

Medtronic REF: MMT-7020C2 Guardian Sensor (3) for the following packaging: GS3 5PK 9L OUS2/ GTIN: 20763000243344 GS3 5PK 9L OUS2/ GTIN: 20763000318868 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 March 1, 2021

Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"

The kit does not have an emergency use authorization (EUA).

ALL 50 STATES
▸Full report

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

Recall #:
88206
Lot/product code:
All lot numbers
Recalling firm:
Cellex
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 1, 2021

MyWay Walker Chassis - Product Usage: is intended for use by children already using a supportive walking device.

Due to a failure of the welds, the casters detached from the rear legs of the walker.

ALL 50 STATES
▸Full report

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

Recall #:
87804
Lot/product code:
Catalog Codes/Item Number: S1 - 173-1600/PMWS1x; S2 - 173-2600/PMWS2x ; S3 - 173-3600/PMWS3x;  Serial Number Range: 220568 to 272111 manufactured between 08/01/2018 to 11/26/2020
Recalling firm:
James Leckey Design Ltd
View official FDA record (opens in a new tab)