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Recalls affecting Utah

Data last updated: September 9, 2026 at 1:18 PM UTC

16,598 recalls found
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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)
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)
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)
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
Class IIModerate risk
DrugRecalled May 29, 2020

amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382213 India Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-178-10

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

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-1347-2020
Lot/product code:
AM181118AA 10/31/2020 AM181191AA 9/30/2020 AM181192AA 9/30/2020 AM181235AA 9/30/2020 AM181236AA 9/30/2020 AM181237AA 9/30/2020 AM181240AA 9/30/2020 AM181241AA 9/30/2020 AM181242AA 9/30/2020 AM181243AA 9/30/2020 AM181244AA 10/31/2020 AM181268AA 10/31/2020 AM181269AA 10/31/2020 AM181270AA 10/30/2020 AM181271AA 10/31/2020 AM181272AA 10/31/2020 AM181273AA 10/31/2020 AM181274AA 10/31/2020 AM181275AA 10/31/2020 AM181276AA 10/31/2020 AM181277AA 10/31/2020 AM181307AA 10/31/2020 AM181308AA 10/31/2020 AM181309AA 10/31/2020 AM181310AA 10/31/2020 AM181311AA 10/31/2020 AM181313AA 10/31/2020 AM181314AA 10/31/2020 AM181315AA 11/30/2020 AM181316AA 11/30/2020 AM181317AA 12/31/2020 AM181419AA 11/30/2020 AM181420AA 11/30/2020 AM181421AA 11/30/2020 AM181422AA 11/30/2020 AM181423AA 11/30/2020 AM181424AA 11/30/2020 AM181425AA 11/30/2020 AM181430BA 12/31/2020 AM181455AA 12/31/2020 AM181456AA 12/31/2020 AM181457AA 12/31/2020 AM181458AA 12/31/2020 AM181459AA 12/31/2020 AM181460AA 12/31/2020 AM181461AA 12/31/2020 AM181462AA 12/31/2020 AM181463AA 12/31/2020 AM181464AA 12/31/2020 AM181465AA 12/31/2020 AM190054AA 12/31/2020 AM190055AA 12/31/2020 AM190057AA 12/31/2020 AM190058AA 12/31/2020 AM190102AA 12/31/2020 AM190103AA 12/31/2020 AM190104AA 12/31/2020 AM190105AA 12/31/2020 AM190106AA 12/31/2020 AM190107AA 12/31/2020 AM190108AA 12/31/2020 AM190120AA 12/31/2020 AM190633AA 5/31/2021 AM190634AA 5/31/2021 AM190635AA 5/31/2021 AM190636AA 5/31/2021 AM190637AA 5/31/2021 AM190638AA 5/31/2021 AM190640AA 5/31/2021 AM190641AA 5/31/2021 AM190642AA 5/31/2021 AM190664AA 5/31/2021 AM190665AA 5/31/2021 AM190666AA 5/31/2021 AM190667AA 5/31/2021 AM190668AA 5/31/2021 AM190669AA 6/30/2021 AM190670AA 6/30/2021 AM190671AA 6/30/2021 AM190672AA 6/30/2021 AM190714AA 6/30/2021 AM190934A 8/31/2021 AM190991A 8/31/2021 AM190992A 8/31/2021 AM190993A 8/31/2021 AM190994A 8/31/2021 AM191040A 9/30/2021 AM191041A 9/30/2021 AM191083A 9/30/2021 AM191084A 9/30/2021 AM191085A 9/30/2021 AM191091A 9/30/2021 AM191092A 9/30/2021 AM191105A 9/30/2021 AM191106A 10/31/2021 AM191107A 10/31/2021 AM191109A 10/31/2021 AM191186A 10/31/2021 AM191187A 10/31/2021 AM191188A 10/31/2021 AM191189A 10/31/2021 AM191190A 10/31/2021 AM191191A 10/31/2021 AM191192A 10/31/2021 AM191193A 10/31/2021 AM191194A 10/31/2021 AM191195A 10/31/2021 AM191244A 10/31/2021 AM191245A 10/31/2021 AM191246A 10/31/2021 AM191247A 10/31/2021 AM191294A 11/30/2021 AM191295A 11/30/2021 AM191296A 11/30/2021 AM191365A 11/30/2021 AM191366A 11/30/2021 AM191367A 11/30/2021 AM191392A 11/30/2021 AM191393A 11/30/2021 AM191394A 11/30/2021 AM191395A 12/31/2021 AM200001A 12/31/2021 AM200002A 12/31/2021 AM200003A 12/31/2021 AM200004A 12/31/2021 AM200005A 12/31/2021 AM200006A 12/31/2021 AM200045A 12/31/2021 AM200046A 12/31/2021 AM200047A 12/31/2021 AM200048A 12/31/2021 AM200049A 12/31/2021 AM200050A 12/31/2021 AM200051A 12/31/2021 AM200052A 12/31/2021 AM200053A 12/31/2021 AM200081A 12/31/2021 AM200082A 12/31/2021 AM200083 12/31/2021 AM200087A 12/31/2021 AM200088A 12/31/2021 AM200089 12/31/2021 AM200090 12/31/2021 AM200091 12/31/2021 AM200100 1/31/2022 AM200101 1/31/2022 AM200102 1/31/2022 AM200138 1/31/2022 AM200139 1/31/2022 AM200140 1/31/2022 AM200141 1/31/2022 AM200142 1/31/2022 AM200143 1/31/2022 AM200144 1/31/2022 AM200193 1/31/2022 AM200194 1/31/2022 AM200195 1/31/2022 AM200196 1/31/2022 AM200197 1/31/2022 AM200198 1/31/2022 AM200199 1/31/2022 AM200200 1/31/2022 AM200202 1/31/2022 AM200203 1/31/2022 AM200204 1/31/2022 AM200205 1/31/2022 AM200206 1/31/2022 AM200207 1/31/2022 AM200208 1/31/2022 AM200209 1/31/2022 AM200210 1/31/2022 AM200211 1/31/2022 AM200284 2/28/2022 AM200285 2/28/2022 AM200287 2/28/2022 AM200288 2/28/2022 AM200289 2/28/2022 AM200290 2/28/2022 AM200291 2/28/2022 AM200292 2/28/2022
Recalling firm:
Amneal Pharmaceuticals of New York, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 29, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-179-10

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

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-1349-2020
Lot/product code:
AM181337A 10/31/2020 AM181338A 10/31/2020 AM181339A 11/30/2020 AM181340A 11/30/2020 AM181341A 11/30/2020 AM181342A 11/30/2020 AM181343A 11/30/2020 AM181344A 11/30/2020 AM181356A 11/30/2020 AM181357A 11/30/2020 AM181358A 11/30/2020 AM181359A 11/30/2020 AM181360A 11/30/2020 AM181361A 11/30/2020 AM181362A 11/30/2020 AM181363A 11/30/2020 AM181415A 11/30/2020 AM190040B 12/31/2020 AM190041A 12/31/2020 AM190042A 12/31/2020 AM190043A 12/31/2020 AM190044A 12/31/2020 AM190045A 12/31/2020 AM190046A 12/31/2020 AM190473B 4/30/2021 AM190474A 4/30/2021 AM190475A 4/30/2021 AM190476A 4/30/2021 AM190477A 4/30/2021 AM190478A 4/30/2021 AM190479A 4/30/2021 AM190480A 4/30/2021 AM190481A 4/30/2021 AM190482A 4/30/2021 AM190834A 7/31/2021 AM190835A 7/31/2021 AM190836A 7/31/2021 AM190837A 7/31/2021 AM190838A 7/31/2021 AM191004A 8/31/2021 AM191005A 8/31/2021 AM191006A 8/31/2021 AM191007A 8/31/2021 AM191008A 9/30/2021 AM191271A 10/31/2021 AM191272A 10/31/2021 AM191273A 10/31/2021 AM191274A 10/31/2021 AM191338A 11/30/2021 AM191339A 11/30/2021 AM191340A 11/30/2021 AM191341 12/31/2021 AM191342 12/31/2021 AM200109 12/31/2021 AM200110 12/31/2021 AM200111 12/31/2021
Recalling firm:
Amneal Pharmaceuticals of New York, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 29, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-10

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

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-1352-2020
Lot/product code:
HF08618A 6/30/2020 HF08718A 6/30/2020 HF15418A 7/31/2020 HF15518A 7/31/2020 HH11818A 9/30/2020 HJ00818A 9/30/2020 HJ00918A 9/30/2020 HJ01018A 9/30/2020
Recalling firm:
Amneal Pharmaceuticals of New York, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 29, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-01

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

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-1348-2020
Lot/product code:
HF02318A 6/30/2020 HF02418A 6/30/2020 HF02518A 6/30/2020 HF07718A 6/30/2020 HH02118A 7/31/2020 HM04418A 12/31/2020 HM04518A 12/31/2020 HM04618A 12/31/2020 HM04718A 12/31/2020 HM05518A 12/31/2020 HM05618A 12/31/2020 HM05718A 12/31/2020 HM05818A 12/31/2020 HM05918A 12/31/2020 HM06018A 12/31/2020
Recalling firm:
Amneal Pharmaceuticals of New York, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 29, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-01

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

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-1343-2020
Lot/product code:
HA07419A 1/31/2021 HB00119A 1/31/2021 HB00219A 1/31/2021 HB00319A 1/31/2021; HB00419A 2/28/2021 HB00519A 2/28/2021 HB00619A 2/28/2021 HB00719A 2/28/2021 HB00819A 2/28/2021 HB00919A 2/28/2021 HB01019A 2/28/2021 HB05119A 2/28/2021 HB05219A 2/28/2021 HB05319A 2/28/2021 HB05419A 2/28/2021 HB05519A 2/28/2021 HB09519A 2/28/2021 HB09619A 2/28/2021 HB09719A 2/28/2021 HB09819A 2/28/2021 HB09919A 2/28/2021; HC08219A 3/31/2021 HC08319A 3/31/2021 HC08419A 3/31/2021 HC08519A 3/31/2021 HC09019A 3/31/2021 HC09119A 3/31/2021 HC09219A 3/31/2021 HC09319A 3/31/2021 HC09419A 3/31/2021; HD03419B 4/30/2021 HD03519B 4/30/2021 HD03619B 4/30/2021 HD03719B 4/30/2021 HD03819B 4/30/2021 HD03919B 4/30/2021 HD04019B 4/30/2021 HD04119B 4/30/2021 HD04219A 4/30/2021 HD05819A 4/30/2021 HD05919A 4/30/2021 HD06019A 4/30/2021 HD06119A 4/30/2021 HD06219A 4/30/2021 HD06319A 4/30/2021 HD06419A 4/30/2021 HD09019A 4/30/2021 HD09119A 4/30/2021 HD09219A 4/30/2021 HE01219B 4/30/2021 HE01319B 4/30/2021 HE01419B 4/30/2021 HE01519B 4/30/2021; HE01619A 5/31/2021 HE01719A 5/31/2021 HE01819A 5/31/2021 HE04419A 5/31/2021 HE04519A 5/31/2021 HE04619A 5/31/2021 HE04719A 5/31/2021 HE04819A 5/31/2021 HE04919A 5/31/2021 HE05019A 5/31/2021 HE05119A 5/31/2021 HE05219A 5/31/2021 HE05319A 5/31/2021 HE07219A 5/31/2021 HE07319A 5/31/2021 HE07419A 5/31/2021 HE07519A 5/31/2021 HE07619A 5/31/2021 HF02219A 5/31/2021 HF02319A 5/31/2021; HF02419A 6/30/2021 HF02519A 6/30/2021 HF02619A 6/30/2021 HF02719A 6/30/2021 HF02819A 6/30/2021 HF02919A 6/30/2021 HF03019A 6/30/2021 HF03119A 6/30/2021 HF03219A 6/30/2021 HF03319A 6/30/2021 HF05419A 6/30/2021; HF03918A 6/30/2020 HF04018A 6/30/2020 HF04118A 6/30/2020 HF04218A 6/30/2020 HF04318A 6/30/2020 HF04418A 6/30/2020 HF06518A 6/30/2020 HF06818B 6/30/2020 HF06918B 6/30/2020 HF07018B 6/30/2020 HF07118B 6/30/2020 HF07218A 6/30/2020 HF07318A 6/30/2020 HF07418A 6/30/2020 HF08318A 6/30/2020 HF08418A 6/30/2020 HF08518A 6/30/2020; HF11219A 6/30/2021 HF11319A 6/30/2021 HF11419A 6/30/2021 HF11519A 6/30/2021 HF11619A 6/30/2021 HF11719A 6/30/2021 HF11819A 6/30/2021 HF11919A 6/30/2021 HF12019A 6/30/2021 HG00719A 6/30/2021 HG00819A 6/30/2021 HG00919A 6/30/2021 HG01019A 6/30/2021 HG01119A 6/30/2021 HG01219A 6/30/2021 HG01319A 6/30/2021 HG01419A 6/30/2021; HG01519A 7/31/2021 HG01619A 7/31/2021 HG02919A 7/31/2021 HG03019A 7/31/2021 HG03119A 7/31/2021 HG03219A 7/31/2021 HG03319A 7/31/2021 HG03419A 7/31/2021 HG03519A 7/31/2021 HG03619A 7/31/2021 HG03719A 7/31/2021 HG03819A 7/31/2021; HH08218A 8/31/2020 HH08318A 8/31/2020 HH08418A 8/31/2020 HH08518A 8/31/2020 HH08618A 8/31/2020 HH08718A 8/31/2020 HH08818A 8/31/2020 HH08918A 8/31/2020 HH09018A 8/31/2020 HH09118A 8/31/2020 HH09218A 8/31/2020 HH09318A 8/31/2020 HH09418A 8/31/2020 HH09518A 8/31/2020 HH09618A 8/31/2020 HH11218A 8/31/2020 HH11318A 8/31/2020 HH11418A 8/31/2020 HH11518A 8/31/2020; HH11618A 9/30/2020 HH11718A 9/30/2020 HJ04818A 9/30/2020 HJ04918A 9/30/2020 HJ08518A 9/30/2020; HJ08618A 10/31/2020 HJ08718A 10/31/2020 HJ08818A 10/31/2020 HJ08918A 10/31/2020 HJ09018A 10/31/2020 HJ09118A 10/31/2020 HK03718A 10/31/2020 HK03818A 10/31/2020 HK03918A 10/31/2020 HK04018A 10/31/2020 HK04118A 10/31/2020 HK04218A 10/31/2020 HK04318A 10/31/2020 HK04418A 10/31/2020 HK04518A 10/31/2020 HK04618A 10/31/2020 HK09318A 10/31/2020 HK09418A 10/31/2020 HK09518A 10/31/2020 HK09618A 10/31/2020 HK09718A 10/31/2020; HM00218A 12/31/2020 HM00318A 12/31/2020 HM00418A 12/31/2020 HM00518A 12/31/2020 HM00618B 12/31/2020 HM00718B 12/31/2020 HM00818B 12/31/2020 HM00918B 12/31/2020 HM01018B 12/31/2020; HM02918A 1/31/2021 HM03018A 1/31/2021 HM03218A 1/31/2021 HM03318A 1/31/2021 HM03418A 1/31/2021 HM03518A 1/31/2021 HM03618A 1/31/2021 HM03718A 1/31/2021 HM03818A 1/31/2021
Recalling firm:
Amneal Pharmaceuticals of New York, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 29, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-BULK

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

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-1350-2020
Lot/product code:
HA01320A 1/31/2021 HA01420A 1/31/2021 HA06820A 1/31/2021 HB03620A 1/31/2021 HB03720A 1/31/2021 HB03820A 1/31/2021 HB03920A 1/31/2021 HB04020A 1/31/2021 HB04120A 1/31/2021 HB04220A 1/31/2021 HB04320A 2/28/2021 HB04420A 1/31/2021 HB04520A 2/28/2021 HB05020A 2/28/2021 HB05120A 2/28/2021 HB05220A 2/28/2021 HB05320A 2/28/2021 HB05420A 2/28/2021 HB05520A 2/28/2021 HB05620A 2/28/2021 HB07020A 2/28/2021 HB07120A 2/28/2021 HB07220A 2/28/2021 HB07320A 2/28/2021 HB07520A 2/28/2021 HB07620A 2/28/2021 HB07720A 2/28/2021 HB07820A 2/28/2021 HB07920A 2/28/2021 HB08020A 2/28/2021 HB08220A 2/28/2021 HF05519A 6/30/2020 HF05619A 6/30/2020 HF05719A 6/30/2020 HF05819A 6/30/2020 HF05919A 6/30/2020 HF06019A 6/30/2020 HF06119A 6/30/2020 HF06219A 6/30/2020 HF06319A 6/30/2020 HF07719A 6/30/2020 HF07819A 6/30/2020 HF07919A 6/30/2020 HF08019A 6/30/2020 HF08119A 6/30/2020 HF08219A 6/30/2020 HF08319A 6/30/2020 HF08419A 6/30/2020 HF08519A 6/30/2020 HF08619A 6/30/2020 HF10119A 6/30/2020 HF10219A 6/30/2020 HF10319A 6/30/2020 HF10419A 6/30/2020 HF10519A 6/30/2020 HF10619A 6/30/2020 HF10719A 6/30/2020 HF10819A 6/30/2020 HF10919A 6/30/2020 HF11019A 6/30/2020 HF11119A 6/30/2020 HG07219A 7/31/2020 HG07319A 7/31/2020 HG07419A 7/31/2020 HG07519A 7/31/2020 HG07619A 7/31/2020 HG07719A 7/31/2020 HG07819A 7/31/2020 HG07919A 7/31/2020 HG08019A 7/31/2020 HG08119A 7/31/2020 HH00619A 7/31/2020 HH00719A 7/31/2020 HH00819A 7/31/2020 HH00919A 7/31/2020 HH01019A 7/31/2020 HH01119A 8/31/2020 HH01219A 8/31/2020 HH01319A 8/31/2020 HH01419A 8/31/2020 HH01519A 8/31/2020 HH07319A 8/31/2020 HH07419A 8/31/2020 HH07519A 8/31/2020 HH07619A 8/31/2020 HH07719A 8/31/2020 HH07819A 8/31/2020 HH07919A 8/31/2020 HH08019A 8/31/2020 HH08119A 8/31/2020 HH08219A 8/31/2020 HH11119A 10/31/2020 HH11219A 10/31/2020 HH11319A 10/31/2020 HH11419A 10/31/2020 HH11519A 10/31/2020 HH11619A 10/31/2020 HH11719A 10/31/2020 HH11819A 10/31/2020 HH11919A 10/31/2020 HH12019A 10/31/2020 HH12119A 10/31/2020 HH12219A 10/31/2020 HH12319A 10/31/2020 HH12419A 10/31/2020 HH12519A 10/31/2020 HH12619A 10/31/2020 HH12719A 10/31/2020 HH12819A 10/31/2020 HH12919A 10/31/2020 HH13019A 10/31/2020 HL00119A 10/31/2020 HL00219A 11/30/2020 HL00319A 11/30/2020 HL00419A 11/30/2020 HL00519A 11/30/2020 HL00619A 11/30/2020 HL00719A 11/30/2020 HL00819A 11/30/2020 HL00919A 11/30/2020 HL01019A 11/30/2020
Recalling firm:
Amneal Pharmaceuticals of New York, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 29, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-05

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

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-1351-2020
Lot/product code:
HF06618A 6/30/2020 HF06718A 6/30/2020
Recalling firm:
Amneal Pharmaceuticals of New York, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 29, 2020

amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 90 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08907 NDC 65162-178-09

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

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-1344-2020
Lot/product code:
AM190123A 1/31/2021 AM190193A 1/31/2021 AM190194A 1/31/2021 AM190195A 1/31/2021 AM190196A 1/31/2021 AM190197A 1/31/2021 AM190198A 1/31/2021 AM190199A 1/31/2021 AM190200A 2/28/2021 AM190201A 2/28/2021 AM190202A 2/28/2021 AM190269A 2/28/2021 AM190270A 2/28/2021 AM190271A 2/28/2021 AM190272A 2/28/2021 AM190289A 2/28/2021 AM190290A 2/28/2021 AM190291A 2/28/2021 AM190292A 2/28/2021 AM190293A 2/28/2021 AM190294A 2/28/2021 AM190549A 4/30/2021 AM190550A 4/30/2021 AM190551A 4/30/2021 AM190552A 4/30/2021 AM190553A 4/30/2021 AM190554A 4/30/2021 AM190555A 5/31/2021 AM190556A 5/31/2021 AM190586A 5/31/2021 AM190587A 5/31/2021 AM190588A 5/31/2021 AM190589A 5/31/2021 AM190590A 5/31/2021 AM190605A 5/31/2021 AM190673A 6/30/2021 AM190707A 6/30/2021 AM190708A 6/30/2021 AM190709A 6/30/2021 AM190710A 6/30/2021 AM190714C 6/30/2021 AM190751C 6/30/2021 AM190752C 6/30/2021 AM190753A 8/31/2021 AM190754A 8/31/2021 AM190755A 8/31/2021 AM190756A 8/31/2021 AM190757A 8/31/2021 AM190929A 8/31/2021 AM190930A 8/31/2021 AM190931A 8/31/2021 AM190932A 8/31/2021 AM190933A 8/31/2021 AM190995A 8/31/2021 AM191000A 8/31/2021 AM191001A 8/31/2021 AM191002A 8/31/2021 AM191003A 8/31/2021 AM191034A 9/30/2021 AM191035A 9/30/2021 AM191036A 9/30/2021 AM191037A 9/30/2021 AM191038A 9/30/2021 AM191039A 9/30/2021 AM191086A 9/30/2021
Recalling firm:
Amneal Pharmaceuticals of New York, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 29, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-0178-11

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

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-1353-2020
Lot/product code:
HF08618A 6/30/2020 HF08718A 6/30/2020 HF15418A 7/31/2020 HF15518A 7/31/2020 HH11818A 9/30/2020 HJ00818A 9/30/2020 HJ00918A 9/30/2020 HJ01018A 9/30/2020
Recalling firm:
Amneal Pharmaceuticals of New York, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 29, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-BULK

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

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-1354-2020
Lot/product code:
HA01520A 1/31/2021 HA01620A 1/31/2021 HG01719A 7/31/2020 HG01819A 7/31/2020 HH09319A 8/31/2020 HH09419A 9/30/2020 HK07619A 10/31/2020 HK07719A 10/31/2020
Recalling firm:
Amneal Pharmaceuticals of New York, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 29, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-90

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

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-1393-2020
Lot/product code:
HB10019A 03-2021 HB10119A 03-2021 HB10219A 03-2021 HB10319A 03-2021 HD02119A 04-2021 HD03319A 04-2021 HF09118A 06-2020 HF11618A 06-2020 HF15218A 07-2020 HF15318A 07-2020 HJ01418A 09-2020 HJ01518A 09-2020 HJ01618A 09-2020 HJ01718A 09-2020 HJ04718A 09-2020 HK03218A 10-2020 HK03318A 10-2020 HK03418A 10-2020 HK03518A 10-2020 HK03618A 10-2020 HK13718A 11-2020 HK13818A 11-2020 HK13918A 11-2020 HK14018A 11-2020 HK14118A 11-2020 HK14218A 11-2020 HK14318A 11-2020 HK14418A 11-2020 HK14518A 11-2020 HM00118A 11-2020
Recalling firm:
Amneal Pharmaceuticals of New York, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 29, 2020

amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-178-50

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

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-1345-2020
Lot/product code:
AM180641A 6/30/2020 AM180642A 6/30/2020 AM180643A 6/30/2020 AM180644A 6/30/2020 AM180645A 6/30/2020 AM180646A 6/30/2020 AM180647A 6/30/2020 AM180880A 7/31/2020 AM180881A 7/31/2020 AM180882A 7/31/2020 AM180883A 7/31/2020 AM180884A 7/31/2020 AM180885A 7/31/2020 AM180886A 7/31/2020 AM180887A 7/31/2020 AM180888A 7/31/2020 AM180889A 7/31/2020 AM180936A 7/31/2020 AM180937A 7/31/2020 AM180938A 7/31/2020 AM180939A 7/31/2020 AM180940A 7/31/2020 AM180960A 7/31/2020 AM180961A 7/31/2020 AM180962A 7/31/2020 AM180963A 7/31/2020 AM180964A 7/31/2020 AM180965A 7/31/2020 AM180992A 7/31/2020 AM180993A 7/31/2020 AM180994A 8/31/2020 AM180995A 8/31/2020 AM180996A 8/31/2020 AM180997A 8/31/2020 AM181037A 8/31/2020 AM181038A 8/31/2020 AM181039A 8/31/2020 AM181040A 8/31/2020 AM181041A 8/31/2020 AM181079A 8/31/2020 AM181080A 8/31/2020 AM181081A 8/31/2020 AM181082A 8/31/2020 AM181083A 8/31/2020 AM181084A 8/31/2020 AM181085A 8/31/2020 AM181086A 8/31/2020 AM181087A 8/31/2020 AM181088A 8/31/2020 AM181089A 8/31/2020 AM181093A 8/31/2020 AM181094A 8/31/2020 AM181095A 8/31/2020 AM181096A 8/31/2020 AM181097A 8/31/2020 AM181098A 8/31/2020 AM181099A 8/31/2020 AM181100A 8/31/2020 AM181101A 8/31/2020 AM181102A 8/31/2020 AM181116A 8/31/2020 AM181117A 9/30/2020 AM181129A 8/31/2020 AM181130A 8/31/2020 AM181131A 8/31/2020 AM181132A 8/31/2020 AM181133A 9/30/2020 AM181134A 9/30/2020 AM181135A 9/30/2020 AM181136A 9/30/2020 AM181137A 9/30/2020 AM181138A 9/30/2020 AM181183A 9/30/2020 AM181184A 9/30/2020 AM181185A 9/30/2020 AM181186A 9/30/2020 AM181187A 9/30/2020 AM181188A 9/30/2020 AM181189A 9/30/2020 AM181190A 9/30/2020 AM181235A 9/30/2020 AM181236A 9/30/2020 AM181237A 9/30/2020 AM181238A 9/30/2020 AM181239A 9/30/2020 AM181240A 9/30/2020 AM181242A 9/30/2020 AM181243A 9/30/2020 AM181314A 10/31/2020 AM181315A 11/30/2020 AM190121B 12/31/2020 AM190122B 12/31/2020 AM190713AA 6/30/2021 AM191248A 10/31/2021 AM191249A 10/31/2021 AM200192 1/31/2022 AM200322A 2/28/2022
Recalling firm:
Amneal Pharmaceuticals of New York, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 3, 2020

HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.

Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.

ALL 50 STATES
▸Full report

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

Recall #:
85794
Lot/product code:
Batch numbers:  J38382   J28715   J24868   J28716   J33647   J43944  J50980   J47108   J57802   J57061   J67133   J74174   J68563  J72691   If a distributor or end user received one of the batches listed above, they need to look at the batch number laser marked on the forceps themselves. If the forceps has any of the following batch numbers laser marked on them and the forceps do not fit with the dental dam clamps, the forceps should be returned to Coltene. Laser marked batch number:  1903 1904 1906 1907 1909 1910 1911 1915 1920 1921 1923 1927 1928 1930 1934 1940
Recalling firm:
Coltene Whaledent Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 3, 2020

PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC, LH-1-15CC - Product Usage: intended for stabilization, transportation, and inactivation of infectious unprocessed nasal washes, nasopharyngeal, oral/throat swabs* suspected of containing Influenza A virus RNA. PS-MTM is also intended for the stabilization, transportation, and inactivation of infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis (MTB) DNA from human samples.

The tubes may have been delivered to some users without labels. Users may not be able to identify the tubes without these labels. If samples stored or transported in tubes are tested on certain systems or come into contact with bleach they can produce cyanide gas. The solution in these tubes contains guanidine thiocynate and may put laboratory personnel at risk of exposure to cyanide gas when it comes into contact with bleach or reagents containing bleach.

ALL 50 STATES
▸Full report

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

Recall #:
86189
Lot/product code:
Lot Numbers: 200421A 200421B E200427A E200427B E2000505B CN200423 CN200427
Recalling firm:
LONGHORN VACCINES AND DIAGNOSTIC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 3, 2020

HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.

Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.

ALL 50 STATES
▸Full report

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

Recall #:
85794
Lot/product code:
Batch numbers: J73571  If a distributor or end user received one of the batches listed above, they need to look at the batch number laser marked on the forceps themselves. If the forceps has any of the following batch numbers laser marked on them and the forceps do not fit with the dental dam clamps, the forceps should be returned to Coltene. Laser marked batch number:  1903 1904 1906 1907 1909 1910 1911 1915 1920 1921 1923 1927 1928 1930 1934 1940
Recalling firm:
Coltene Whaledent Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 3, 2020

HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.

Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.

ALL 50 STATES
▸Full report

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

Recall #:
85794
Lot/product code:
Batch numbers: J16743 J16745 J29784 J31289 J33607 J44177 J44178 J44840 J47109 J47110 J49167 J67132 J73572 J73785 J74711  If a distributor or end user received one of the batches listed above, they need to look at the batch number laser marked on the forceps themselves. If the forceps has any of the following batch numbers laser marked on them and the forceps do not fit with the dental dam clamps, the forceps should be returned to Coltene. Laser marked batch number: 1903 1904 1906 1907 1909 1910 1911 1915 1920 1921 1923 1927 1928 1930 1934 1940
Recalling firm:
Coltene Whaledent Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 3, 2020

HYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.

Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.

ALL 50 STATES
▸Full report

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

Recall #:
85794
Lot/product code:
Batch numbers: J74546  J74184    If a distributor or end user received one of the batches listed above, they need to look at the batch number laser marked on the forceps themselves. If the forceps has any of the following batch numbers laser marked on them and the forceps do not fit with the dental dam clamps, the forceps should be returned to Coltene. Laser marked batch number:  1903 1904 1906 1907 1909 1910 1911 1915 1920 1921 1923 1927 1928 1930 1934 1940
Recalling firm:
Coltene Whaledent Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2020

Patient Connector, Model Number 24967

There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check", EffectivCRT" algorithms, and AdaptivCRT"). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.

ALL 50 STATES
▸Full report

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

Recall #:
85816
Lot/product code:
serial numbers: RFA001342A RFA001412A RFA001748A RFA001760A RFA001802A RFA001845A RFA001868A RFA001885A RFA002011A RFA002039A RFA002152A RFA003642A RFA003644A RFA003652A RFA003658A RFA003669A RFA003671A RFA003673A RFA003677A RFA003684A RFA003690A RFA003691A RFA003692A RFA003703A RFA003704A RFA003705A RFA004075A RFA004079A RFA004082A RFA004208A RFA004218A RFA004232A RFA004277A RFA004386A RFA004390A RFA004391A RFA004681A RFA004706A RFA005006A RFA005009A RFA005011A RFA005023A RFA005025A RFA005028A RFA005029A RFA005049A RFA005079A RFA005081A RFA005093A RFA005095A RFA005097A RFA005103A RFA005105A RFA005125A RFA005249A RFA005989A RFA006832A RFA008087A RFA008119A RFA008908A RFA009323A RFA010721A RFA010722A RFA010895A RFA011167A RFA011196A RFA011348A RFA011359A RFA011456A RFA011493A RFA011519A RFA011725A RFA011764A RFA011770A RFA011774A RFA011780A RFA011795A RFA011796A RFA011797A RFA011824A RFA011827A RFA011840A RFA011846A RFA011859A RFA011860A RFA011862A RFA011872A RFA011879A RFA011885A RFA011898A RFA011919A RFA011927A RFA011928A RFA011931A RFA011933A RFA011938A RFA011952A RFA011958A RFA011959A RFA011966A RFA011973A RFA011976A RFA011978A RFA012031A RFA012034A RFA012048A RFA012124A RFA012126A RFA012129A RFA012133A RFA012149A RFA012155A RFA012158A RFA012159A RFA012160A RFA012164A RFA012167A RFA012174A RFA012176A RFA012188A RFA012198A RFA012199A RFA012200A RFA012201A RFA012202A RFA012205A RFA012223A RFA012227A RFA012230A RFA012233A RFA012234A RFA012235A RFA012260A RFA012273A RFA012274A RFA012276A RFA012277A RFA012279A RFA012290A RFA012301A RFA012309A RFA012328A RFA012369A RFA012411A RFA012412A RFA012423A RFA012433A RFA012441A RFA012449A RFA012450A RFA012469A RFA012476A RFA012496A RFA012506A RFA012521A RFA012527A RFA012530A RFA012531A RFA012532A RFA012535A RFA012539A RFA012542A RFA012554A RFA012556A RFA012562A RFA012571A RFA012580A RFA012586A RFA012587A RFA012590A RFA012598A RFA012603A RFA012611A RFA012624A RFA012633A RFA012636A RFA012639A RFA012643A RFA012647A RFA012654A RFA012658A RFA012661A RFA012667A RFA012676A RFA012678A RFA012679A RFA012693A RFA012696A RFA012707A RFA012708A RFA012719A RFA012721A RFA012727A RFA012754A RFA012757A RFA012759A RFA012763A RFA012768A RFA012771A RFA012781A RFA012786A RFA012791A RFA012802A RFA012805A RFA012807A RFA012812A RFA012813A RFA012831A RFA012882A RFA012976A RFA013056A RFA013060A RFA013063A RFA013066A RFA013067A RFA013069A RFA013070A RFA013074A RFA013086A RFA013090A RFA013093A RFA013099A RFA013105A RFA013121A RFA013127A RFA013129A RFA013162A RFA013163A RFA013164A RFA013165A RFA013167A RFA013168A RFA013169A RFA013170A RFA013171A RFA013172A RFA013174A RFA013175A RFA013201A RFA013203A RFA013204A RFA013207A RFA013208A RFA013209A RFA013210A RFA013211A RFA013213A RFA013227A RFA013228A RFA013233A RFA013235A RFA013237A RFA013239A RFA013251A RFA013255A RFA013264A RFA013265A RFA013267A RFA013269A RFA013271A RFA013274A RFA013275A RFA013277A RFA013278A RFA013279A RFA013301A RFA013303A RFA013314A RFA013328A RFA013330A RFA013388A RFA013412A RFA013414A RFA013435A RFA013453A RFA013458A RFA013465A RFA013468A RFA013490A RFA013494A RFA013516A RFA013537A RFA013557A RFA013562A RFA013566A RFA013576A RFA013584A RFA013612A RFA013719A RFA013721A RFA013730A RFA013732A RFA013734A RFA013735A RFA013745A RFA013746A RFA013754A RFA013780A RFA013787A RFA013794A RFA013800A RFA013830A RFA013832A RFA013833A RFA013888A RFA013895A RFA013901A RFA013904A RFA013905A RFA013946A RFA013952A RFA013962A RFA013981A RFA014454A RFA014479A RFA014508A RFA014527A RFA014693A RFA014710A RFA014762A RFA014772A RFA014778A RFA014781A RFA014785A RFA014787A RFA014809A RFA014810A RFA014813A RFA014816A RFA014829A RFA014837A RFA014848A RFA014854A RFA015059A RFA015060A RFA015068A RFA015074A RFA015076A RFA015099A RFA015103A RFA015107A RFA015112A RFA015133A RFA015145A RFA015149A RFA015156A RFA015160A RFA015165A RFA015178A RFA015179A RFA015186A RFA015187A RFA015198A RFA015201A RFA015202A RFA015204A RFA015207A RFA015218A RFA015223A RFA015231A RFA015271A RFA015272A RFA015276A RFA015281A RFA015290A RFA015292A RFA015297A RFA015298A RFA015299A RFA015304A RFA015311A RFA015313A RFA015320A RFA015322A RFA015326A RFA015338A RFA015339A RFA015347A RFA015348A RFA015349A RFA015352A RFA015356A RFA015357A RFA015361A RFA015364A RFA015401A RFA015402A RFA015403A RFA015410A RFA015415A RFA015417A RFA015418A RFA015419A RFA015423A RFA015427A RFA015428A RFA015429A RFA015430A RFA015438A RFA015439A RFA015443A RFA015448A RFA015455A RFA015459A RFA015465A RFA015467A RFA015468A RFA015470A RFA015471A RFA015472A RFA015480A RFA015486A RFA015493A RFA015497A RFA015498A RFA015499A RFA015501A RFA015502A RFA015567A RFA015568A RFA015573A RFA015574A RFA015576A RFA015577A RFA015579A RFA015581A RFA015582A RFA015587A RFA015588A RFA015590A RFA015592A RFA015595A RFA015598A RFA015600A RFA015601A RFA015610A RFA015611A RFA015614A RFA015616A RFA015620A RFA015621A RFA015622A RFA015624A RFA015630A RFA015631A RFA015633A RFA015635A RFA015638A RFA015647A RFA015648A RFA015651A RFA015654A RFA015659A … (truncated, 11291 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2020

Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04

There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check", EffectivCRT" algorithms, and AdaptivCRT"). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.

ALL 50 STATES
▸Full report

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

Recall #:
85816
Lot/product code:
a) W1TR01, serial numbers: RNO200006H RNO200023H RNO200029H RNO200036H RNO200038H RNO200041H RNO200044H RNO200048H RNO200050H RNO200051H RNO200064H RNO200070H RNO200086H RNO200088H RNO200096H RNO200105H RNO200109H RNO200110H RNO200136H RNO200140H RNO200012H RNO200013H RNO200025H RNO200030H RNO200031H RNO200034H RNO200035H RNO200037H RNO200043H RNO200046H RNO200047H RNO200054H RNO200055H RNO200056H RNO200058H RNO200060H RNO200061H RNO200065H RNO200067H RNO200068H RNO200069H RNO200071H RNO200072H RNO200074H RNO200075H RNO200076H RNO200078H RNO200079H RNO200081H RNO200082H RNO200084H RNO200085H RNO200087H RNO200091H RNO200093H RNO200098H RNO200099H RNO200101H RNO200111H RNO200112H RNO200115H RNO200116H RNO200118H RNO200121H RNO200122H RNO200125H RNO200127H RNO200128H RNO200129H RNO200131H RNO200132H RNO200133H RNO200134H RNO200137H RNO200138H RNO200141H RNO200143H RNO200144H RNO200145H RNO200027H RNO200100H RNO200106H RNO200151H RNO200155H RNO200162H RNO200103H RNO200165H RNO200166H RNO200167H RNO200168H RNO200169H RNO200171H RNO200173H RNO200174H RNO200175H RNO200178H RNO200179H RNO200180H RNO200181H RNO200182H RNO200183H RNO200184H RNO200185H RNO200186H RNO200187H RNO200188H RNO200189H RNO200190H RNO200192H RNO200193H RNO200194H RNO200040H RNO200102H RNO200146H RNO200148H RNO200150H RNO200157H RNO200158H RNO200159H RNO200161H RNO200163H RNO200164H RNO200172H RNO200059H RNO200080H RNO200160H RNO200196H RNO200197H RNO200198H RNO200199H RNO200200H RNO200201H RNO200203H RNO200204H RNO200205H RNO200206H RNO200207H RNO200208H RNO200209H RNO200210H RNO200211H RNO200212H RNO200213H RNO200215H RNO200216H RNO200218H RNO200220H RNO200222H RNO200223H RNO200224H RNO200225H RNO200228H RNO200229H RNO200230H RNO200231H RNO200233H RNO200235H RNO200236H RNO200239H RNO200240H RNO200241H RNO200242H RNO200243H RNO200245H RNO200246H RNO200247H RNO200248H RNO200250H RNO200252H RNO200253H RNO200254H RNO200255H RNO200256H RNO200257H RNO200258H RNO200259H RNO200260H RNO200261H RNO200262H RNO200263H RNO200266H RNO200268H RNO200269H RNO200270H RNO200271H RNO200272H RNO200274H RNO200276H RNO200279H RNO200280H RNO200281H RNO200282H RNO200284H RNO200286H RNO200287H RNO200288H RNO200291H RNO200293H RNO200294H RNO200295H RNO200297H RNO200298H RNO200299H RNO200300H RNO200301H RNO200303H RNO200305H RNO200309H RNO200310H RNO200311H RNO200313H RNO200314H RNO200315H RNO200316H RNO200318H RNO200319H RNO200320H RNO200321H RNO200323H RNO200324H RNO200275H RNO200290H RNO200292H RNO200296H RNO200053H RNO200077H RNO200277H RNO200307H RNO200325H RNO200326H RNO200327H RNO200330H RNO200331H RNO200335H RNO200336H RNO200342H RNO200343H RNO200344H RNO200349H RNO200351H RNO200353H RNO200356H RNO200357H RNO200358H RNO200359H RNO200363H RNO200369H RNO200371H RNO200373H RNO200380H RNO200381H RNO200382H RNO200383H RNO200384H RNO200332H RNO200346H RNO200368H RNO200339H RNO200348H RNO200352H RNO200354H RNO200355H RNO200361H RNO200367H RNO200414H RNO200416H RNO200418H RNO200420H RNO200425H RNO200430H RNO200434H RNO200441H RNO200413H RNO200415H RNO200419H RNO200421H RNO200422H RNO200423H RNO200426H RNO200427H RNO200428H RNO200429H RNO200431H RNO200432H RNO200435H RNO200436H RNO200437H RNO200439H RNO200440H RNO200273H RNO200333H RNO200334H RNO200265H RNO200350H RNO200375H RNO200377H RNO200379H RNO200389H RNO200459H RNO200472H RNO200478H RNO200479H RNO200484H RNO200485H RNO200496H RNO200502H RNO200504H RNO200505H RNO200507H RNO200509H RNO200510H RNO200511H RNO200518H RNO200519H RNO200525H RNO200529H RNO200531H RNO200532H RNO200533H RNO200534H RNO200010H RNO200386H RNO200387H RNO200388H RNO200391H RNO200393H RNO200394H RNO200395H RNO200396H RNO200397H RNO200401H RNO200402H RNO200404H RNO200405H RNO200406H RNO200407H RNO200410H RNO200443H RNO200446H RNO200447H RNO200448H RNO200449H RNO200452H RNO200453H RNO200456H RNO200460H RNO200461H RNO200462H RNO200463H RNO200464H RNO200465H RNO200466H RNO200467H RNO200468H RNO200469H RNO200470H RNO200471H RNO200474H RNO200475H RNO200476H RNO200481H RNO200482H RNO200483H RNO200489H RNO200490H RNO200492H RNO200494H RNO200497H RNO200500H RNO200501H RNO200508H RNO200512H RNO200514H RNO200516H RNO200517H RNO200520H RNO200521H RNO200537H RNO200539H RNO200522H RNO200523H RNO200527H RNO200536H RNO200586H RNO200618H RNO200619H RNO200392H RNO200398H RNO200408H RNO200411H RNO200444H RNO200454H RNO200563H RNO200565H RNO200568H RNO200578H RNO200611H RNO200622H RNO200623H RNO200624H RNO200627H RNO200632H RNO200634H RNO200635H RNO200654H RNO200340H RNO200542H RNO200545H RNO200555H RNO200556H RNO200561H RNO200564H RNO200566H RNO200567H RNO200569H RNO200572H RNO200574H RNO200575H RNO200577H RNO200584H RNO200588H RNO200590H RNO200593H RNO200594H RNO200596H RNO200598H RNO200600H RNO200602H RNO200608H RNO200613H RNO200614H RNO200616H RNO200629H RNO200630H RNO200636H RNO200637H RNO200638H RNO200652H RNO200661H RNO200662H RNO200666H RNO200677H RNO200678H RNO200680H RNO200685H RNO200689H RNO200692H RNO200694H RNO200695H RNO200696H RNO200698H RNO200365H R… (truncated, 411070 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2020

Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01

There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check", EffectivCRT" algorithms, and AdaptivCRT"). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.

ALL 50 STATES
▸Full report

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

Recall #:
85816
Lot/product code:
a) W1DR01, serial numbers: RNB200043H RNB200044H RNB200045H RNB200046H RNB200047H RNB200048H RNB200049H RNB200050H RNB200051H RNB200052H RNB200053H RNB200054H RNB200055H RNB200056H RNB200057H RNB200058H RNB200059H RNB200060H RNB200064H RNB200065H RNB200066H RNB200067H RNB200068H RNB200069H RNB200070H RNB200071H RNB200072H RNB200073H RNB200074H RNB200075H RNB200076H RNB200079H RNB200080H RNB200081H RNB200082H RNB200083H RNB200084H RNB200085H RNB200086H RNB200087H RNB200088H RNB200089H RNB200091H RNB200094H RNB200095H RNB200096H RNB200098H RNB200099H RNB200100H RNB200101H RNB200102H RNB200103H RNB200105H RNB200106H RNB200107H RNB200108H RNB200109H RNB200111H RNB200112H RNB200113H RNB200114H RNB200115H RNB200116H RNB200117H RNB200118H RNB200119H RNB200120H RNB200121H RNB200122H RNB200123H RNB200124H RNB200125H RNB200126H RNB200127H RNB200128H RNB200129H RNB200130H RNB200131H RNB200132H RNB200133H RNB200135H RNB200136H RNB200137H RNB200138H RNB200139H RNB200140H RNB200141H RNB200143H RNB200144H RNB200145H RNB200146H RNB200147H RNB200148H RNB200149H RNB200150H RNB200151H RNB200153H RNB200154H RNB200155H RNB200156H RNB200158H RNB200159H RNB200160H RNB200161H RNB200163H RNB200164H RNB200165H RNB200166H RNB200167H RNB200168H RNB200169H RNB200170H RNB200171H RNB200173H RNB200174H RNB200175H RNB200176H RNB200178H RNB200179H RNB200180H RNB200181H RNB200184H RNB200185H RNB200186H RNB200187H RNB200188H RNB200190H RNB200191H RNB200193H RNB200195H RNB200197H RNB200198H RNB200199H RNB200201H RNB200202H RNB200205H RNB200206H RNB200207H RNB200208H RNB200209H RNB200210H RNB200211H RNB200213H RNB200214H RNB200215H RNB200216H RNB200219H RNB200220H RNB200221H RNB200222H RNB200223H RNB200224H RNB200225H RNB200226H RNB200227H RNB200228H RNB200229H RNB200231H RNB200232H RNB200233H RNB200234H RNB200235H RNB200236H RNB200237H RNB200239H RNB200240H RNB200241H RNB200242H RNB200243H RNB200244H RNB200245H RNB200246H RNB200248H RNB200249H RNB200250H RNB200251H RNB200252H RNB200253H RNB200254H RNB200255H RNB200256H RNB200257H RNB200258H RNB200259H RNB200260H RNB200262H RNB200264H RNB200265H RNB200266H RNB200267H RNB200268H RNB200269H RNB200270H RNB200271H RNB200272H RNB200273H RNB200274H RNB200275H RNB200276H RNB200277H RNB200278H RNB200279H RNB200280H RNB200281H RNB200282H RNB200283H RNB200284H RNB200285H RNB200286H RNB200287H RNB200289H RNB200290H RNB200292H RNB200293H RNB200294H RNB200295H RNB200296H RNB200297H RNB200298H RNB200299H RNB200300H RNB200301H RNB200302H RNB200303H RNB200304H RNB200305H RNB200306H RNB200307H RNB200308H RNB200309H RNB200310H RNB200311H RNB200313H RNB200314H RNB200315H RNB200316H RNB200317H RNB200318H RNB200319H RNB200320H RNB200321H RNB200322H RNB200323H RNB200325H RNB200327H RNB200328H RNB200329H RNB200330H RNB200331H RNB200332H RNB200333H RNB200334H RNB200335H RNB200336H RNB200337H RNB200338H RNB200342H RNB200343H RNB200344H RNB200345H RNB200346H RNB200348H RNB200349H RNB200350H RNB200352H RNB200353H RNB200354H RNB200355H RNB200356H RNB200357H RNB200358H RNB200359H RNB200360H RNB200361H RNB200363H RNB200364H RNB200365H RNB200366H RNB200367H RNB200368H RNB200369H RNB200371H RNB200373H RNB200375H RNB200376H RNB200379H RNB200380H RNB200381H RNB200382H RNB200383H RNB200384H RNB200390H RNB200391H RNB200392H RNB200394H RNB200395H RNB200396H RNB200398H RNB200399H RNB200400H RNB200404H RNB200406H RNB200408H RNB200409H RNB200410H RNB200411H RNB200414H RNB200415H RNB200417H RNB200419H RNB200420H RNB200422H RNB200423H RNB200424H RNB200426H RNB200063H RNB200092H RNB200104H RNB200134H RNB200377H RNB200430H RNB200432H RNB200433H RNB200435H RNB200436H RNB200437H RNB200438H RNB200439H RNB200440H RNB200442H RNB200443H RNB200444H RNB200445H RNB200447H RNB200448H RNB200451H RNB200452H RNB200454H RNB200458H RNB200459H RNB200462H RNB200464H RNB200465H RNB200470H RNB200476H RNB200477H RNB200478H RNB200483H RNB200486H RNB200372H RNB200427H RNB200428H RNB200431H RNB200434H RNB200446H RNB200453H RNB200455H RNB200456H RNB200460H RNB200463H RNB200466H RNB200467H RNB200468H RNB200471H RNB200474H RNB200475H RNB200491H RNB200374H RNB200461H RNB200487H RNB200378H RNB200403H RNB200405H RNB200407H RNB200412H RNB200416H RNB200418H RNB200421H RNB200449H RNB200457H RNB200479H RNB200481H RNB200485H RNB200499H RNB200501H RNB200504H RNB200516H RNB200519H RNB200522H RNB200528H RNB200532H RNB200535H RNB200538H RNB200539H RNB200387H RNB200393H RNB200401H RNB200450H RNB200469H RNB200482H RNB200488H RNB200489H RNB200498H RNB200508H RNB200509H RNB200511H RNB200518H RNB200520H RNB200521H RNB200523H RNB200534H RNB200536H RNB200492H RNB200510H RNB200514H RNB200515H RNB200524H RNB200529H RNB200530H RNB200540H RNB200546H RNB200548H RNB200490H RNB200494H RNB200495H RNB200500H RNB200502H RNB200503H RNB200505H RNB200506H RNB200507H RNB200525H RNB200526H RNB200531H RNB200533H RNB200541H RNB200542H RNB200545H RNB200547H RNB200549H RNB200551H RNB200339H RNB200564H RNB200571H RNB200579H RNB200583H RNB200586H RNB200590H RNB200591H RNB200594H RNB200596H RNB200597H … (truncated, 2928830 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2020

CareLink SmartSync Device Manager, Model Number 24970A

There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check", EffectivCRT" algorithms, and AdaptivCRT"). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.

ALL 50 STATES
▸Full report

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

Recall #:
85816
Lot/product code:
serial numbers: SPM001078A SPM001117A SPM001120A SPM001139A SPM001140A SPM001141A SPM001174A SPM001231A SPM001250A SPM001251A SPM001252A SPM001253A SPM001262A SPM001265A SPM001266A SPM001270A SPM001281A SPM001284A SPM001285A SPM001363A SPM001377A SPM001394A SPM001396A SPM001398A SPM001403A SPM001404A SPM001407A SPM001419A SPM001424A SPM001425A SPM001441A SPM001445A SPM001449A SPM001456A SPM001463A SPM001465A SPM001474A SPM001477A SPM001478A SPM001482A SPM001484A SPM001486A SPM001491A SPM001519A SPM001544A SPM001545A SPM001552A SPM001554A SPM001555A SPM001556A SPM001557A SPM001559A SPM001560A SPM001561A SPM001562A SPM001571A SPM001581A SPM001584A SPM001587A SPM001588A SPM001633A SPM001659A SPM001660A SPM001661A SPM001662A SPM001663A SPM001664A SPM001665A SPM001666A SPM001667A SPM001668A SPM001669A SPM001670A SPM001671A SPM001672A SPM001673A SPM001674A SPM001675A SPM001676A SPM001677A SPM001683A SPM001684A SPM001685A SPM001686A SPM001704A SPM001705A SPM001706A SPM001707A SPM001709A SPM001710A SPM001711A SPM001712A SPM001713A SPM001714A SPM001715A SPM001716A SPM001719A SPM001720A SPM001721A SPM001723A SPM001732A SPM001733A SPM001734A SPM001735A SPM001738A SPM001739A SPM001745A SPM001746A SPM001747A SPM001748A SPM001749A SPM001751A SPM001753A SPM001754A SPM001756A SPM001759A SPM001760A SPM001766A SPM001771A SPM001774A SPM001775A SPM001776A SPM001779A SPM001781A SPM001782A SPM001784A SPM001786A SPM001787A SPM001793A SPM001795A SPM001796A SPM001798A SPM001799A SPM001800A SPM001802A SPM001803A SPM001805A SPM001806A SPM001807A SPM001808A SPM001809A SPM001812A SPM001813A SPM001816A SPM001817A SPM001818A SPM001842A SPM001846A SPM001875A SPM001878A SPM001880A SPM001883A SPM001884A SPM001885A SPM001889A SPM001896A SPM001901A SPM001929A SPM001935A SPM001936A SPM001961A SPM001967A SPM001971A SPM001973A SPM001974A SPM001975A SPM001976A SPM001977A SPM001982A SPM001983A SPM001984A SPM001985A SPM001986A SPM001988A SPM001989A SPM002001A SPM002005A SPM002024A SPM002035A SPM002041A SPM002068A SPM002072A SPM002085A SPM002107A SPM002108A SPM002109A SPM002110A SPM002113A SPM002114A SPM002115A SPM002117A SPM002121A SPM002122A SPM002125A SPM002129A SPM002130A SPM002131A SPM002132A SPM002134A SPM002145A SPM002150A SPM002179A SPM002198A SPM002205A SPM002213A SPM002217A SPM002219A SPM002232A SPM002268A SPM002269A SPM002292A SPM002294A SPM002295A SPM002310A SPM002312A SPM002315A SPM002316A SPM002335A SPM002342A SPM002343A SPM002344A SPM002347A SPM002365A SPM002367A SPM002373A SPM002374A SPM002375A SPM002386A SPM002416A SPM002424A SPM002451A SPM002456A SPM002458A SPM002459A SPM002460A SPM002461A SPM002462A SPM002463A SPM002464A SPM002465A SPM002538A SPM002540A SPM002542A SPM002546A SPM002547A SPM002553A SPM002554A SPM002555A SPM002557A SPM002558A SPM002559A SPM002560A SPM002561A SPM002562A SPM002563A SPM002565A SPM002568A SPM002569A SPM002572A SPM002595A SPM002597A SPM002599A SPM002600A SPM002601A SPM002602A SPM002603A SPM002604A SPM002606A SPM002608A SPM002609A SPM002610A SPM002611A SPM002612A SPM002613A SPM002614A SPM002615A SPM002616A SPM002617A SPM002618A SPM002656A SPM002657A SPM002658A SPM002659A SPM002660A SPM002661A SPM002662A SPM002663A SPM002664A SPM002665A SPM002698A SPM002699A SPM002703A SPM002704A SPM002705A SPM002706A SPM002708A SPM002709A SPM002710A SPM002711A SPM002712A SPM002714A SPM002736A SPM002756A SPM002885A SPM002997A SPM003000A SPM003001A SPM003035A SPM003036A SPM003037A SPM003038A SPM003042A SPM003043A SPM003046A SPM003047A SPM003048A SPM003051A SPM003053A SPM003054A SPM003058A SPM003059A SPM003060A SPM003061A SPM003063A SPM003064A SPM003065A SPM003066A SPM003067A SPM003068A SPM003069A SPM003070A SPM003071A SPM003073A SPM003074A SPM003078A SPM003079A SPM003080A SPM003081A SPM003082A SPM003084A SPM003085A SPM003087A SPM003088A SPM003092A SPM003105A SPM003108A SPM003134A SPM003136A SPM003137A SPM003140A SPM003142A SPM003410A SPM003411A SPM003444A SPM003446A SPM003447A SPM003448A SPM003449A SPM003450A SPM003451A SPM003465A SPM003472A SPM003473A SPM003474A SPM003475A SPM003476A SPM003477A SPM003478A SPM003479A SPM003480A SPM003481A SPM003482A SPM003516A SPM003517A SPM003518A SPM003519A SPM003520A SPM003521A SPM003522A SPM003523A SPM003524A SPM003525A SPM003529A SPM003530A SPM003531A SPM003532A SPM003533A SPM003534A SPM003535A SPM003536A SPM003537A SPM003538A SPM003557A SPM003558A SPM003559A SPM003565A SPM003587A SPM003589A SPM003590A SPM003591A SPM003592A SPM003593A SPM003594A SPM003595A SPM003596A SPM003597A SPM003598A SPM003599A SPM003600A SPM003601A SPM003602A SPM003605A SPM003607A SPM003608A SPM003610A SPM003611A SPM003612A SPM003668A SPM003669A SPM003679A SPM003680A SPM003682A SPM003683A SPM003684A SPM003685A SPM003686A SPM003687A SPM003689A SPM003690A SPM003691A SPM003692A SPM003697A SPM003698A SPM003699A SPM003700A SPM003701A SPM003702A SPM003703A SPM003704A SPM003705A SPM003706A SPM003708A SPM003712A SPM003716A SPM003717A SPM003718A SPM003719A SPM003721A SPM003722A SPM003723A SPM003725A SPM003741A SPM003742A … (truncated, 30519 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2020

Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06

There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check", EffectivCRT" algorithms, and AdaptivCRT"). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.

ALL 50 STATES
▸Full report

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

Recall #:
85816
Lot/product code:
a) W1TR03, serial numbers: RNS200027H RNS200037H RNS200043H RNS200044H RNS200045H RNS200052H RNS200059H RNS200063H RNS200068H RNS200076H RNS200077H RNS200079H RNS200081H RNS200088H RNS200089H RNS200090H RNS200094H RNS200098H RNS200100H RNS200005H RNS200007H RNS200016H RNS200020H RNS200022H RNS200025H RNS200026H RNS200028H RNS200030H RNS200032H RNS200033H RNS200034H RNS200038H RNS200042H RNS200050H RNS200051H RNS200054H RNS200060H RNS200061H RNS200064H RNS200065H RNS200067H RNS200071H RNS200072H RNS200074H RNS200080H RNS200082H RNS200084H RNS200085H RNS200086H RNS200087H RNS200091H RNS200093H RNS200099H RNS200101H RNS200053H RNS200104H RNS200109H RNS200111H RNS200116H RNS200118H RNS200019H RNS200040H RNS200092H RNS200035H RNS200102H RNS200103H RNS200105H RNS200107H RNS200108H RNS200110H RNS200113H RNS200115H RNS200117H RNS200119H RNS200120H RNS200121H RNS200122H RNS200123H RNS200125H RNS200126H RNS200127H RNS200048H RNS200128H RNS200130H RNS200140H RNS200124H RNS200129H RNS200143H RNS200144H RNS200131H RNS200138H RNS200132H RNS200136H RNS200137H RNS200133H RNS200134H RNS200135H RNS200148H RNS200149H RNS200150H RNS200151H RNS200154H RNS200155H RNS200156H RNS200158H RNS200159H RNS200160H RNS200161H RNS200162H RNS200163H RNS200164H RNS200165H RNS200167H RNS200168H RNS200169H RNS200170H RNS200171H RNS200172H RNS200173H RNS200174H RNS200175H RNS200176H RNS200177H RNS200178H RNS200179H RNS200181H RNS200185H RNS200193H RNS200194H RNS200195H RNS200196H RNS200198H RNS200199H RNS200202H RNS200203H RNS200204H RNS200206H RNS200207H RNS200210H RNS200212H RNS200213H RNS200214H RNS200215H RNS200216H RNS200217H RNS200220H RNS200223H RNS200224H RNS200226H RNS200227H RNS200228H RNS200230H RNS200232H RNS200182H RNS200183H RNS200186H RNS200191H RNS200200H RNS200205H RNS200229H RNS200231H RNS200142H RNS200218H RNS200233H RNS200234H RNS200235H RNS200236H RNS200237H RNS200239H RNS200240H RNS200243H RNS200245H RNS200246H RNS200247H RNS200248H RNS200251H RNS200252H RNS200253H RNS200255H RNS200256H RNS200258H RNS200259H RNS200260H RNS200242H RNS200238H RNS200296H RNS200299H RNS200301H RNS200302H RNS200307H RNS200335H RNS200340H RNS200350H RNS200359H RNS200369H RNS200187H RNS200309H RNS200311H RNS200313H RNS200314H RNS200316H RNS200318H RNS200321H RNS200327H RNS200329H RNS200330H RNS200331H RNS200332H RNS200333H RNS200334H RNS200336H RNS200337H RNS200345H RNS200346H RNS200347H RNS200348H RNS200349H RNS200353H RNS200355H RNS200356H RNS200360H RNS200363H RNS200364H RNS200367H RNS200368H RNS200266H RNS200268H RNS200273H RNS200275H RNS200281H RNS200283H RNS200286H RNS200287H RNS200289H RNS200291H RNS200293H RNS200324H RNS200325H RNS200339H RNS200343H RNS200357H RNS200361H RNS200010H RNS200262H RNS200263H RNS200264H RNS200265H RNS200267H RNS200270H RNS200274H RNS200276H RNS200278H RNS200279H RNS200280H RNS200288H RNS200290H RNS200303H RNS200315H RNS200317H RNS200319H RNS200326H RNS200370H RNS200284H RNS200285H RNS200294H RNS200298H RNS200306H RNS200310H RNS200341H RNS200354H RNS200365H RNS200391H RNS200392H RNS200393H RNS200394H RNS200398H RNS200401H RNS200402H RNS200405H RNS200376H RNS200380H RNS200382H RNS200383H RNS200385H RNS200389H RNS200399H RNS200372H RNS200373H RNS200374H RNS200377H RNS200381H RNS200384H RNS200388H RNS200390H RNS200395H RNS200396H RNS200397H RNS200400H RNS200297H RNS200145H RNS200407H RNS200408H RNS200410H RNS200412H RNS200413H RNS200414H RNS200420H RNS200421H RNS200422H RNS200423H RNS200424H RNS200430H RNS200406H RNS200409H RNS200411H RNS200415H RNS200418H RNS200425H RNS200426H RNS200427H RNS200428H RNS200432H RNS200440H RNS200449H RNS200451H RNS200454H RNS200434H RNS200435H RNS200444H RNS200446H RNS200448H RNS200450H RNS200455H RNS200456H RNS200433H RNS200436H RNS200437H RNS200438H RNS200439H RNS200441H RNS200442H RNS200443H RNS200445H RNS200453H RNS200338H RNS200459H RNS200461H RNS200462H RNS200463H RNS200464H RNS200465H RNS200466H RNS200467H RNS200468H RNS200469H RNS200471H RNS200472H RNS200473H RNS200474H RNS200475H RNS200476H RNS200477H RNS200479H RNS200480H RNS200481H RNS200482H RNS200484H RNS200485H RNS200486H RNS200487H RNS200488H RNS200489H RNS200490H RNS200491H RNS200492H RNS200494H RNS200495H RNS200457H RNS200493H RNS200496H RNS200497H RNS200498H RNS200501H RNS200505H RNS200506H RNS200507H RNS200503H RNS200504H RNS200510H RNS200508H RNS200509H RNS200511H RNS200512H RNS200521H RNS200525H RNS200528H RNS200532H RNS200564H RNS200571H RNS200523H RNS200526H RNS200527H RNS200563H RNS200567H RNS200515H RNS200514H RNS200516H RNS200517H RNS200519H RNS200531H RNS200536H RNS200553H RNS200558H RNS200561H RNS200565H RNS200566H RNS200529H RNS200533H RNS200534H RNS200537H RNS200541H RNS200546H RNS200548H RNS200551H RNS200555H RNS200568H RNS200569H RNS200572H RNS200556H RNS200573H RNS200578H RNS200581H RNS200588H RNS200591H RNS200597H RNS200600H RNS200610H RNS200615H RNS200618H RNS200621H RNS200623H RNS200624H RNS200628H RNS200629H RNS200547H RNS200574H RNS200576H RNS200579H RNS200582H RNS200583H RNS200585H RNS200587H R… (truncated, 183447 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2020

Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05

There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check", EffectivCRT" algorithms, and AdaptivCRT"). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.

ALL 50 STATES
▸Full report

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

Recall #:
85816
Lot/product code:
a) W1TR02, serial numbers: RNQ200008H RNQ200032H RNQ200035H RNQ200043H RNQ200045H RNQ200049H RNQ200051H RNQ200052H RNQ200057H RNQ200059H RNQ200061H RNQ200074H RNQ200076H RNQ200080H RNQ200096H RNQ200100H RNQ200102H RNQ200107H RNQ200109H RNQ200110H RNQ200111H RNQ200130H RNQ200132H RNQ200133H RNQ200003H RNQ200005H RNQ200006H RNQ200007H RNQ200010H RNQ200011H RNQ200017H RNQ200018H RNQ200020H RNQ200022H RNQ200025H RNQ200028H RNQ200029H RNQ200031H RNQ200033H RNQ200034H RNQ200036H RNQ200039H RNQ200040H RNQ200050H RNQ200054H RNQ200056H RNQ200060H RNQ200062H RNQ200064H RNQ200065H RNQ200067H RNQ200071H RNQ200072H RNQ200075H RNQ200077H RNQ200078H RNQ200081H RNQ200085H RNQ200088H RNQ200091H RNQ200093H RNQ200098H RNQ200103H RNQ200105H RNQ200108H RNQ200115H RNQ200116H RNQ200119H RNQ200120H RNQ200123H RNQ200124H RNQ200125H RNQ200126H RNQ200128H RNQ200131H RNQ200135H RNQ200137H RNQ200141H RNQ200145H RNQ200146H RNQ200147H RNQ200152H RNQ200154H RNQ200157H RNQ200158H RNQ200162H RNQ200167H RNQ200168H RNQ200169H RNQ200171H RNQ200174H RNQ200012H RNQ200134H RNQ200136H RNQ200139H RNQ200140H RNQ200183H RNQ200149H RNQ200150H RNQ200159H RNQ200160H RNQ200163H RNQ200176H RNQ200178H RNQ200179H RNQ200180H RNQ200181H RNQ200186H RNQ200188H RNQ200189H RNQ200198H RNQ200199H RNQ200206H RNQ200210H RNQ200217H RNQ200229H RNQ200234H RNQ200238H RNQ200245H RNQ200247H RNQ200248H RNQ200249H RNQ200196H RNQ200202H RNQ200204H RNQ200212H RNQ200221H RNQ200230H RNQ200235H RNQ200244H RNQ200191H RNQ200200H RNQ200203H RNQ200233H RNQ200192H RNQ200193H RNQ200194H RNQ200195H RNQ200208H RNQ200215H RNQ200231H RNQ200241H RNQ200302H RNQ200246H RNQ200274H RNQ200275H RNQ200280H RNQ200281H RNQ200282H RNQ200283H RNQ200284H RNQ200285H RNQ200286H RNQ200287H RNQ200303H RNQ200307H RNQ200272H RNQ200278H RNQ200292H RNQ200251H RNQ200255H RNQ200259H RNQ200261H RNQ200262H RNQ200265H RNQ200266H RNQ200300H RNQ200250H RNQ200256H RNQ200258H RNQ200263H RNQ200267H RNQ200277H RNQ200254H RNQ200260H RNQ200264H RNQ200269H RNQ200291H RNQ200374H RNQ200387H RNQ200368H RNQ200369H RNQ200376H RNQ200383H RNQ200384H RNQ200385H RNQ200386H RNQ200373H RNQ200227H RNQ200370H RNQ200372H RNQ200375H RNQ200378H RNQ200379H RNQ200389H RNQ200394H RNQ200381H RNQ200398H RNQ200399H RNQ200404H RNQ200405H RNQ200400H RNQ200401H RNQ200402H RNQ200403H RNQ200430H RNQ200432H RNQ200433H RNQ200434H RNQ200436H RNQ200438H RNQ200444H RNQ200449H RNQ200450H RNQ200408H RNQ200409H RNQ200443H RNQ200456H RNQ200417H RNQ200420H RNQ200427H RNQ200407H RNQ200410H RNQ200413H RNQ200414H RNQ200415H RNQ200421H RNQ200423H RNQ200426H RNQ200459H RNQ200462H RNQ200425H RNQ200460H RNQ200411H RNQ200471H RNQ200475H RNQ200416H RNQ200418H RNQ200429H RNQ200457H RNQ200463H RNQ200464H RNQ200472H RNQ200474H RNQ200519H RNQ200442H RNQ200446H RNQ200467H RNQ200468H RNQ200490H RNQ200494H RNQ200499H RNQ200465H RNQ200479H RNQ200480H RNQ200482H RNQ200485H RNQ200487H RNQ200495H RNQ200497H RNQ200502H RNQ200507H RNQ200509H RNQ200512H RNQ200514H RNQ200516H RNQ200520H RNQ200524H RNQ200470H RNQ200473H RNQ200477H RNQ200484H RNQ200491H RNQ200492H RNQ200496H RNQ200501H RNQ200466H RNQ200481H RNQ200486H RNQ200488H RNQ200489H RNQ200508H RNQ200513H RNQ200515H RNQ200454H RNQ200510H RNQ200518H RNQ200435H RNQ200448H RNQ200469H RNQ200493H RNQ200526H RNQ200527H RNQ200529H RNQ200530H RNQ200533H RNQ200534H RNQ200535H RNQ200541H RNQ200544H RNQ200547H RNQ200553H RNQ200554H RNQ200531H RNQ200542H RNQ200558H RNQ200561H RNQ200546H RNQ200549H RNQ200555H RNQ200537H RNQ200540H RNQ200545H RNQ200565H RNQ200570H RNQ200589H RNQ200252H RNQ200569H RNQ200601H RNQ200568H RNQ200597H RNQ200595H RNQ200605H RNQ200603H RNQ200604H RNQ200607H RNQ200609H RNQ200610H RNQ200633H RNQ200634H RNQ200636H RNQ200638H RNQ200643H RNQ200644H RNQ200645H RNQ200646H RNQ200648H RNQ200635H RNQ200640H RNQ200614H RNQ200618H RNQ200623H RNQ200625H RNQ200626H RNQ200632H RNQ200637H RNQ200650H RNQ200651H RNQ200652H RNQ200613H RNQ200615H RNQ200616H RNQ200617H RNQ200619H RNQ200620H RNQ200621H RNQ200622H RNQ200624H RNQ200627H RNQ200628H RNQ200629H RNQ200630H RNQ200631H RNQ200653H RNQ200660H RNQ200667H RNQ200669H RNQ200654H RNQ200658H RNQ200661H RNQ200668H RNQ200671H RNQ200190H RNQ200655H RNQ200659H RNQ200662H RNQ200664H RNQ200665H RNQ200670H RNQ200656H RNQ200673H RNQ200674H RNQ200675H RNQ200676H RNQ200677H RNQ200679H RNQ200680H RNQ200681H RNQ200682H RNQ200688H RNQ200689H RNQ200692H RNQ200701H RNQ200702H RNQ200704H RNQ200707H RNQ200683H RNQ200687H RNQ200690H RNQ200693H RNQ200694H RNQ200695H RNQ200697H RNQ200698H RNQ200699H RNQ200700H RNQ200703H RNQ200709H RNQ200710H RNQ200711H RNQ200712H RNQ200714H RNQ200715H RNQ200716H RNQ200717H RNQ200718H RNQ200721H RNQ200722H RNQ200723H RNQ200724H RNQ200727H RNQ200728H RNQ200729H RNQ200731H RNQ200732H RNQ200733H RNQ200734H RNQ200735H RNQ200737H RNQ200738H RNQ200740H RNQ200741H RNQ200742H RNQ200743H RNQ200744H RNQ200747H RNQ200749H RNQ200750H RNQ200752H RNQ200753H RNQ200756H RNQ200759H RNQ200760H RNQ200761H RNQ200762H RNQ200763H RNQ200765H RNQ200766H RNQ200767H RNQ200686H RNQ200708H RNQ200770H R… (truncated, 195361 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2020

Azure S SR MRI, Model Number W3SR01

There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check", EffectivCRT" algorithms, and AdaptivCRT"). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.

ALL 50 STATES
▸Full report

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

Recall #:
85816
Lot/product code:
serial numbers: RNI200028H RNI200029H RNI200031H RNI200033H RNI200034H RNI200037H RNI200038H RNI200039H RNI200041H RNI200042H RNI200043H RNI200044H RNI200045H RNI200046H RNI200048H RNI200050H RNI200051H RNI200053H RNI200054H RNI200055H RNI200057H RNI200058H RNI200059H RNI200061H RNI200063H RNI200064H RNI200065H RNI200066H RNI200067H RNI200069H RNI200071H RNI200072H RNI200076H RNI200077H RNI200078H RNI200079H RNI200080H RNI200081H RNI200082H RNI200083H RNI200084H RNI200085H RNI200086H RNI200087H RNI200088H RNI200089H RNI200090H RNI200091H RNI200094H RNI200095H RNI200096H RNI200097H RNI200098H RNI200099H RNI200100H RNI200101H RNI200102H RNI200103H RNI200104H RNI200105H RNI200106H RNI200107H RNI200108H RNI200109H RNI200111H RNI200112H RNI200113H RNI200115H RNI200118H RNI200119H RNI200121H RNI200122H RNI200123H RNI200124H RNI200125H RNI200126H RNI200127H RNI200128H RNI200130H RNI200132H RNI200134H RNI200135H RNI200137H RNI200138H RNI200139H RNI200140H RNI200141H RNI200142H RNI200144H RNI200146H RNI200147H RNI200148H RNI200149H RNI200150H RNI200151H RNI200152H RNI200155H RNI200156H RNI200157H RNI200158H RNI200159H RNI200160H RNI200161H RNI200162H RNI200163H RNI200164H RNI200166H RNI200167H RNI200168H RNI200169H RNI200170H RNI200171H RNI200172H RNI200173H RNI200174H RNI200175H RNI200180H RNI200181H RNI200182H RNI200183H RNI200184H RNI200186H RNI200187H RNI200188H RNI200195H RNI200202H RNI200203H RNI200116H RNI200143H RNI200177H RNI200178H RNI200191H RNI200192H RNI200193H RNI200194H RNI200196H RNI200197H RNI200198H RNI200199H RNI200200H RNI200201H RNI200060H RNI200092H RNI200210H RNI200211H RNI200214H RNI200236H RNI200241H RNI200243H RNI200270H RNI200273H RNI200280H RNI200282H RNI200300H RNI200302H RNI200303H RNI200304H RNI200305H RNI200312H RNI200313H RNI200315H RNI200327H RNI200330H RNI200335H RNI200347H RNI200359H RNI200371H RNI200208H RNI200209H RNI200219H RNI200230H RNI200232H RNI200240H RNI200268H RNI200284H RNI200287H RNI200296H RNI200326H RNI200338H RNI200363H RNI200372H RNI200255H RNI200265H RNI200278H RNI200344H RNI200348H RNI200349H RNI200350H RNI200351H RNI200353H RNI200354H RNI200356H RNI200357H RNI200360H RNI200388H RNI200408H RNI200310H RNI200325H RNI200380H RNI200245H RNI200246H RNI200248H RNI200249H RNI200250H RNI200251H RNI200254H RNI200256H RNI200257H RNI200258H RNI200260H RNI200261H RNI200263H RNI200264H RNI200266H RNI200271H RNI200274H RNI200275H RNI200277H RNI200279H RNI200381H RNI200382H RNI200383H RNI200384H RNI200385H RNI200387H RNI200389H RNI200390H RNI200392H RNI200394H RNI200395H RNI200396H RNI200397H RNI200398H RNI200399H RNI200401H RNI200402H RNI200403H RNI200404H RNI200405H RNI200407H RNI200411H RNI200412H RNI200414H RNI200416H RNI200417H RNI200418H RNI200420H RNI200421H RNI200423H RNI200424H RNI200425H RNI200427H RNI200429H RNI200430H RNI200432H RNI200435H RNI200436H RNI200437H RNI200438H RNI200439H RNI200440H RNI200221H RNI200319H RNI200362H RNI200204H RNI200205H RNI200206H RNI200207H RNI200212H RNI200213H RNI200216H RNI200217H RNI200218H RNI200220H RNI200222H RNI200223H RNI200224H RNI200226H RNI200227H RNI200228H RNI200229H RNI200231H RNI200234H RNI200235H RNI200237H RNI200238H RNI200242H RNI200269H RNI200281H RNI200285H RNI200290H RNI200297H RNI200298H RNI200299H RNI200301H RNI200308H RNI200309H RNI200311H RNI200317H RNI200328H RNI200329H RNI200336H RNI200340H RNI200341H RNI200345H RNI200352H RNI200355H RNI200358H RNI200364H RNI200366H RNI200368H RNI200370H RNI200373H RNI200374H RNI200375H RNI200376H RNI200378H RNI200379H RNI200393H RNI200410H RNI200215H RNI200276H RNI200337H RNI200365H RNI200441H RNI200442H RNI200444H RNI200445H RNI200446H RNI200448H RNI200449H RNI200459H RNI200460H RNI200461H RNI200462H RNI200463H RNI200465H RNI200466H RNI200467H RNI200468H RNI200447H RNI200450H RNI200451H RNI200453H RNI200454H RNI200455H RNI200456H RNI200464H RNI200470H RNI200472H RNI200474H RNI200475H RNI200476H RNI200477H RNI200478H RNI200479H RNI200482H RNI200484H RNI200486H RNI200487H RNI200488H RNI200489H RNI200490H RNI200491H RNI200492H RNI200493H RNI200494H RNI200496H RNI200498H RNI200499H RNI200501H RNI200502H RNI200503H RNI200504H RNI200505H RNI200506H RNI200507H RNI200508H RNI200509H RNI200510H RNI200511H RNI200512H RNI200513H RNI200514H RNI200515H RNI200070H RNI200036H RNI200133H RNI200176H RNI200286H RNI200516H RNI200518H RNI200519H RNI200520H RNI200521H RNI200523H RNI200524H RNI200525H RNI200526H RNI200528H RNI200529H RNI200530H RNI200532H RNI200533H RNI200535H RNI200537H RNI200538H RNI200539H RNI200542H RNI200543H RNI200544H RNI200545H RNI200546H RNI200547H RNI200548H RNI200549H RNI200553H RNI200554H RNI200555H RNI200556H RNI200557H RNI200558H RNI200559H RNI200560H RNI200561H RNI200565H RNI200566H RNI200567H RNI200568H RNI200569H RNI200570H RNI200572H RNI200573H RNI200574H RNI200575H RNI200579H RNI200580H RNI200582H RNI200583H RNI200584H RNI200585H RNI200586H RNI200587H RNI200590H RNI200591H RNI200593H RNI200594H RNI200595H RNI200596H RNI200597H RNI200599H RNI200602H RNI200604H … (truncated, 131499 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2020

Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01

There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check", EffectivCRT" algorithms, and AdaptivCRT"). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.

ALL 50 STATES
▸Full report

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

Recall #:
85816
Lot/product code:
a) W1SR01, serial numbers: RNA200005H RNA200007H RNA200011H RNA200013H RNA200016H RNA200017H RNA200020H RNA200021H RNA200022H RNA200024H RNA200025H RNA200026H RNA200028H RNA200029H RNA200089H RNA200090H RNA200091H RNA200092H RNA200093H RNA200094H RNA200095H RNA200096H RNA200098H RNA200100H RNA200102H RNA200103H RNA200104H RNA200105H RNA200106H RNA200107H RNA200108H RNA200109H RNA200110H RNA200111H RNA200112H RNA200113H RNA200114H RNA200115H RNA200116H RNA200118H RNA200119H RNA200120H RNA200121H RNA200122H RNA200123H RNA200125H RNA200126H RNA200127H RNA200128H RNA200130H RNA200131H RNA200132H RNA200133H RNA200134H RNA200135H RNA200136H RNA200139H RNA200140H RNA200141H RNA200142H RNA200144H RNA200145H RNA200146H RNA200147H RNA200148H RNA200149H RNA200150H RNA200151H RNA200152H RNA200154H RNA200155H RNA200157H RNA200158H RNA200160H RNA200161H RNA200162H RNA200163H RNA200164H RNA200165H RNA200169H RNA200170H RNA200171H RNA200172H RNA200173H RNA200174H RNA200176H RNA200177H RNA200178H RNA200179H RNA200180H RNA200181H RNA200182H RNA200183H RNA200184H RNA200186H RNA200187H RNA200188H RNA200189H RNA200190H RNA200191H RNA200192H RNA200193H RNA200194H RNA200195H RNA200196H RNA200197H RNA200198H RNA200199H RNA200200H RNA200202H RNA200203H RNA200204H RNA200205H RNA200207H RNA200209H RNA200210H RNA200211H RNA200212H RNA200214H RNA200215H RNA200216H RNA200219H RNA200220H RNA200221H RNA200223H RNA200224H RNA200225H RNA200226H RNA200227H RNA200228H RNA200229H RNA200231H RNA200234H RNA200235H RNA200236H RNA200238H RNA200239H RNA200240H RNA200241H RNA200242H RNA200244H RNA200245H RNA200246H RNA200247H RNA200248H RNA200250H RNA200251H RNA200252H RNA200255H RNA200256H RNA200257H RNA200258H RNA200260H RNA200261H RNA200263H RNA200265H RNA200266H RNA200267H RNA200269H RNA200270H RNA200271H RNA200272H RNA200273H RNA200274H RNA200275H RNA200276H RNA200277H RNA200278H RNA200279H RNA200280H RNA200282H RNA200283H RNA200284H RNA200285H RNA200286H RNA200287H RNA200288H RNA200289H RNA200291H RNA200292H RNA200294H RNA200295H RNA200296H RNA200297H RNA200298H RNA200299H RNA200300H RNA200301H RNA200303H RNA200304H RNA200305H RNA200306H RNA200307H RNA200308H RNA200309H RNA200310H RNA200311H RNA200312H RNA200313H RNA200314H RNA200315H RNA200316H RNA200317H RNA200318H RNA200320H RNA200321H RNA200322H RNA200323H RNA200324H RNA200325H RNA200326H RNA200327H RNA200328H RNA200329H RNA200330H RNA200331H RNA200332H RNA200334H RNA200335H RNA200336H RNA200337H RNA200338H RNA200339H RNA200340H RNA200342H RNA200343H RNA200344H RNA200345H RNA200346H RNA200349H RNA200350H RNA200351H RNA200352H RNA200353H RNA200354H RNA200355H RNA200356H RNA200357H RNA200358H RNA200359H RNA200360H RNA200361H RNA200364H RNA200365H RNA200367H RNA200368H RNA200369H RNA200370H RNA200373H RNA200374H RNA200375H RNA200376H RNA200377H RNA200378H RNA200379H RNA200383H RNA200384H RNA200385H RNA200386H RNA200387H RNA200388H RNA200389H RNA200390H RNA200391H RNA200392H RNA200394H RNA200395H RNA200396H RNA200397H RNA200398H RNA200399H RNA200400H RNA200401H RNA200402H RNA200403H RNA200404H RNA200405H RNA200406H RNA200407H RNA200408H RNA200410H RNA200411H RNA200412H RNA200413H RNA200414H RNA200415H RNA200417H RNA200418H RNA200420H RNA200422H RNA200423H RNA200424H RNA200426H RNA200427H RNA200428H RNA200429H RNA200430H RNA200431H RNA200432H RNA200433H RNA200434H RNA200435H RNA200436H RNA200437H RNA200438H RNA200439H RNA200440H RNA200441H RNA200442H RNA200443H RNA200444H RNA200446H RNA200137H RNA200452H RNA200462H RNA200471H RNA200485H RNA200487H RNA200492H RNA200500H RNA200454H RNA200455H RNA200461H RNA200490H RNA200496H RNA200561H RNA200563H RNA200564H RNA200447H RNA200448H RNA200449H RNA200453H RNA200457H RNA200458H RNA200459H RNA200460H RNA200463H RNA200465H RNA200466H RNA200468H RNA200469H RNA200470H RNA200472H RNA200473H RNA200474H RNA200475H RNA200477H RNA200478H RNA200479H RNA200480H RNA200483H RNA200484H RNA200486H RNA200488H RNA200489H RNA200493H RNA200494H RNA200495H RNA200497H RNA200560H RNA200562H RNA200501H RNA200502H RNA200503H RNA200505H RNA200506H RNA200507H RNA200508H RNA200509H RNA200510H RNA200511H RNA200512H RNA200514H RNA200515H RNA200517H RNA200518H RNA200519H RNA200520H RNA200521H RNA200522H RNA200526H RNA200528H RNA200530H RNA200531H RNA200532H RNA200533H RNA200535H RNA200536H RNA200537H RNA200538H RNA200539H RNA200542H RNA200543H RNA200544H RNA200545H RNA200546H RNA200547H RNA200548H RNA200550H RNA200551H RNA200553H RNA200554H RNA200557H RNA200559H RNA200565H RNA200566H RNA200568H RNA200570H RNA200571H RNA200572H RNA200574H RNA200576H RNA200577H RNA200582H RNA200583H RNA200584H RNA200585H RNA200586H RNA200587H RNA200588H RNA200589H RNA200590H RNA200591H RNA200592H RNA200595H RNA200596H RNA200597H RNA200598H RNA200601H RNA200602H RNA200603H RNA200604H RNA200606H RNA200607H RNA200608H RNA200609H RNA200610H RNA200611H RNA200612H RNA200613H RNA200614H RNA200615H RNA200616H RNA200618H RNA200619H RNA200620H RNA200621H RNA200622H RNA200624H RNA200456H RNA200482H RNA200504H … (truncated, 349151 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)