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Recalls affecting Massachusetts

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

16,989 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)
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 June 4, 2021

SIGNA Artist, Nuclear Magnetic Resonance Imaging System

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

ALL 50 STATES
▸Full report

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

Recall #:
88147
Lot/product code:
N/A
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2021

SIGNA MR380, Nuclear Magnetic Resonance Imaging System

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

ALL 50 STATES
▸Full report

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

Recall #:
88147
Lot/product code:
N/A
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2021

SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

ALL 50 STATES
▸Full report

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

Recall #:
88147
Lot/product code:
N/A
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2021

Discovery MR750 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

ALL 50 STATES
▸Full report

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

Recall #:
88147
Lot/product code:
N/A
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2021

SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

ALL 50 STATES
▸Full report

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

Recall #:
88147
Lot/product code:
N/A
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2021

1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

ALL 50 STATES
▸Full report

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

Recall #:
88147
Lot/product code:
N/A
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2021

SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

ALL 50 STATES
▸Full report

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

Recall #:
88147
Lot/product code:
N/A
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2021

SIGNA Architect - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

ALL 50 STATES
▸Full report

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

Recall #:
88147
Lot/product code:
N/A
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2021

SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

ALL 50 STATES
▸Full report

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

Recall #:
88147
Lot/product code:
N/A
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2021

SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

ALL 50 STATES
▸Full report

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

Recall #:
88147
Lot/product code:
Not Available
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 7, 2021

Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.

During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.

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▸Full report

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

Recall #:
88158
Lot/product code:
Endurant IIs Stent Graft System: Model (REF):ESBF3214C103E GTIN: 00643169439962 Serial Numbers: V29780773; V29780771; V29780759; Model (REF): ESBF3614C103EE GTIN: 00643169780460 Serial Numbers: V29781932; V29781933; V29781934; V29781935; V29781936; V29781937; V29781938; V29781939; V29781940; V29781941; V29781942; V29781943; V29781944; V29781945; V29781946; V29781947; V29781948; V29781951;
Recalling firm:
Medtronic Vascular, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 7, 2021

Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.

During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.

GAMAMDNYSCTXWAWV
▸Full report

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

Recall #:
88158
Lot/product code:
Endurant II Stent Graft System: Model (REF): ETCF3636C49EE GTIN: 00763000099626 Serial Numbers: V29778214; V29778215; Model (REF): ETUF3214C102EE GTIN: 00643169780958 Serial Numbers: V29775791; V29775792; V29775793; V29775794; V29775795; Model (REF): ETBF3216C166EE GTIN: 00763000099626 Serial Numbers: V29778214; V29778215; Model (REF): ETUF3614C102E GTIN: 00643169232631 Serial Numbers: V29781886 V29781883 V29781889 V29781887 V29781890 V29781891 V29781882
Recalling firm:
Medtronic Vascular, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 9, 2021

Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0468-56

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

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-0699-2021
Lot/product code:
Lots 00019213, Exp 31 Jan 2022 & EC6994, Exp May 31, 2023
Recalling firm:
Pfizer Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 9, 2021

Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0469-56

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit

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-0701-2021
Lot/product code:
Lots EC9843, Exp 31, Mar 2023; EA6080, Exp. 31, Mar 2023.
Recalling firm:
Pfizer Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 9, 2021

Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets), Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, Made in Ireland, NDC 0069-0471-03.

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit

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-0700-2021
Lot/product code:
Lots 00020231, Exp 30 Sept 2021; 00020232, Exp 30 Nov 2021; 00020357, Exp 31 Dec 2021; 00020358, Exp 31, Jan 2022; 00020716, Exp 31, Jan 2022 ; ET1600, Exp 31, Jan 2023; ET1607, Exp 31, Jan 2023 & ET1609, Exp 31, Jan 2023.
Recalling firm:
Pfizer Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 10, 2021

REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866

There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results

ALL 50 STATES
▸Full report

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

Recall #:
88123
Lot/product code:
Lot Numbers / Expiration Date  84126UN20 / 09JUL2021 03676UN20 / 25AUG2021 10597UN20 / 29AUG2021 26275UN20 / 20OCT2021 77748UN20 / 08DEC2021 65958UN20 / 08DEC2021 81824UN21 / 16FEB2022
Recalling firm:
Abbott Laboratories
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 10, 2021

REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine Aminotransferase Reagent Kit,, IVD, CE, UDI: (01) 00380740132569

There is a potential for 15% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results.

ALL 50 STATES
▸Full report

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

Recall #:
88123
Lot/product code:
Lot Numbers / Expiration Date  83459UN20 /09JUL2021, 03168UN20 /25SEP2021, 09787UN20 /24OCT2021, 37977UN20 /01JAN2022, 63000UN20 /01JAN2022, 77745UN20 /08JAN2022, 77743UN21 /02MAR2022, 09237UN21 /09APR2022
Recalling firm:
Abbott Laboratories
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 10, 2021

REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740017866

There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results

ALL 50 STATES
▸Full report

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

Recall #:
88123
Lot/product code:
Lot Numbers / Expiration Date  15014UN20 20OCT2021 09153UN21 09MAR2022  *Not distributed within the US.
Recalling firm:
Abbott Laboratories
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 10, 2021

REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161859

There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results

ALL 50 STATES
▸Full report

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

Recall #:
88123
Lot/product code:
Lot Numbers / Expiration Date  02954UN20 / 29AUG2021 37921UN20 / 01DEC2021 81823UN21 / 16FEB2022
Recalling firm:
Abbott Laboratories
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2021

CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N;

Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.

AKALARAZCACTDCDEFLGAHIIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRSCSDTNTXUTVAVTWAWIWV
▸Full report

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

Recall #:
88113
Lot/product code:
Model Number/Description: ENVEOR-L/DELIV SYS EnVeoR-L OREVAC 18Fr GTIN: 00643169800922 Lot Numbers: 0010199879; 0010204030; 0010209069; 0010209070; 0010279048; 0010281657; 0010289860; 0010296299;  Model Number/Description: ENVEOR-N/DELIV SYS EnVeoR-N OREVAC 20Fr GTIN: 00643169800946 Lot Numbers 0010199873; 0010199874; 0010209064; 0010211942; 0010253924; 0010258778; 0010260161; 0010262936; 0010289861; 0010296302; 0010297110; 0010301887;
Recalling firm:
Medtronic Heart Valves Division
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2021

CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;

Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.

AKALARAZCACTDCDEFLGAHIIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRSCSDTNTXUTVAVTWAWIWV
▸Full report

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

Recall #:
88113
Lot/product code:
Model Number/Description: D-EVPROP2329US/DELIV SYS D-EVPROP2329US GTIN:00763000207854 Lot Numbers: 0010165308; 0010165310; 0010165312; 0010165313; 0010169462; 0010169464; 0010171866; 0010171868; 0010171869; 0010173361; 0010175293; 0010175294; 0010181410; 0010181411; 0010181412; 0010182735; 0010182736; 0010188541; 0010192246; 0010192247; 0010197788; 0010197790; 0010199877; 0010199878; 0010199880; 0010204029; 0010216175; 0010216176; 0010222009; 0010222011; 0010225047; 0010271291; 0010271292; 0010271293; 0010273071; 0010279050; 0010279938; 0010288574; 0010289862; 0010291595; 0010291597; 0010294650; 0010294651; 0010294652; 0010296300; 0010296301;  Model Number/Description:D-EVPROP34US/DELIV SYS D-EVPROP34US SA GTIN:00763000207861 Lot Numbers: 0010165309; 0010165311; 0010291593; 0010294653; 0010294654; 0010303395;
Recalling firm:
Medtronic Heart Valves Division
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2021

CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;

Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.

AKALARAZCACTDCDEFLGAHIIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRSCSDTNTXUTVAVTWAWIWV
▸Full report

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

Recall #:
88113
Lot/product code:
Model Number/Description: ENVPRO-14-US/18FR DELIV SYS ENVPRO-14-US GTIN:00643169987203 Lot Numbers: 0009679690; 0009688651; 0009690887; 0009693142; 0009716570; 0009718679; 0009724715; 0009735112; 0009747816; 0009747817; 0009769716; 0009780304; 0009780312; 0009813675; 0009819798; 0009833186; 0009833187; 0009835584; 0009884743; 0009903576; 0009909651; 0009911878; 0009916760; 0009674373;  Model Number/Description: ENVPRO-14/18FR DELIV SYS ENVPRO-14 GTIN: 00643169987258 Lot Numbers 0009674373; 0009677041; 0009681843; 0009686572; 0009696943; 0009702501; 0009708314; 0009720707; 0009730833; 0009732864; 0009735111; 0009741277; 0009745282; 0009751537; 0009751539; 0009753928; 0009753930; 0009759086; 0009763571; 0009765704; 0009765705; 0009769796; 0009771781; 0009778377; 0009780306; 0009780315; 0009797642; 0009801629; 0009801632; 0009815902; 0009815904; 0009819795; 0009824816; 0009827178; 0009827180; 0009831363; 0009831364; 0009839737; 0009843479; 0009846259; 0009872399; 0009872400; 0009875230; 0009877165; 0009879171; 0009882762; 0009882764; 0009885245; 0009888373; 0009894468; 0009894469; 0009896248; 0009899816; 0009902780; 0009903577; 0009905476; 0009907434; 0009916758; 0009924441; 0009930619; 0009930620; 0009932436; 0009935871; 0009940329; 0009941896; 0009943765; 0009943766; 0009950526; 0009956449; 0009959205; 0009959208; 0009968628; 0009971361; 0009973690; 0009974884; 0009974886; 0009979351; 0009981603; 0009981605; 0009992252; 0009992254; 0009999409; 0010001291; 0010004099; 0010004100; 0010007364; 0010007368; 0010010945; 0010014267; 0010017314; 0010017315; 0010021500; 0010021501; 0010024637; 0010026718; 0010028933; 0010030671; 0010032826; 0010032828; 0010037869; 0010037870; 0010037876; 0010040826; 0010040828; 0010044464; 0010044465; 0010051010; 0010051348; 0010054636; 0010058015; 0010061411; 0010061412; 0010063249; 0010063250; 0010081656; 0010083965; 0010087639; 0010091721; 0010091723; 0010097384; 0010097385; 0010099753; 0010099756; 0010100832; 0010100833; 0010100834; 0010100835; 0010105882; 0010105884; 0010108127; 0010108133; 0010108134; 0010108135; 0010120343; 0010124203; 0010126036; 0010129931; 0010131801; 0010133987; 0010136245; 0010136247; 0010139633; 0010139634; 0010143248; 0010143249; 0010143251; 0010145133; 0010148991; 0010153126; 0010153127; 0010153129; 0010157415; 0010161319; 0010163782; 0010169460; 0010169463; 0010169465; 0010175290; 0010175291; 0010175292; 0010184723; 0010184724; 0010184725; 0010188540; 0010194379; 0010194380; 0010197789; 0010199885; 0010204027; 0010209066; 0010211940; 0010211941; 0010220455; 0010245329; 0010248119; 0010249598; 0010252313; 0010253923; 0010255302; 0010256429; 0010256431; 0010257814; 0010258779; 0010260159; 0010261391; 0010262934; 0010268205; 0010268207; 0010269513; 0010271607; 0010273066; 0010273067; 0010275572; 0010275573; 0010278032; 0010278033; 0010281654; 0010282945; 0010285882; 0010285884; 0010286952; 0010286953; 0010288572; 0010288573; 0010288575; 0010289863; 0010297581; 0010297582; 0010301885;  Model Number/Description: ENVPRO-16-US/20FR DELIV SYS ENVPRO-16-US GTIN:00643169987210 Lot Numbers: 0009674372; 0009677040; 0009679689; 0009681842; 0009688649; 0009688650; 0009688652; 0009693140; 0009693141; 0009693143; 0009700507; 0009702502; 0009708313; 0009710330; 0009716568; 0009716569; 0009716571; 0009718678; 0009722417; 0009722418; 0009724713; 0009724714; 0009729071; 0009730831; 0009732861; 0009732863; 0009737234; 0009737235; 0009741276; 0009743440; 0009751538; 0009751540; 0009753926; 0009753929; 0009759085; 0009771780; 0009774180; 0009778376; 0009780303; 0009780308; 0009780311; 0009780314; 0009788697; 0009788698; 0009801633; 0009810569; 0009810570; 0009811909; 0009813678; 0009819800; 0009821182; 0009822855; 0009823656; 0009829625; 0009833190; 0009837505; 0009839738; 0009839739; 0009839740; 0009845304; 0009867880; 0009867881; 0009872402; 0009877163; 0009879660; 0009880134; 0009909647; 0009909649; 0009914677; 0009916004; 0009916759; 0009916762; 0009916764; 0009922784; 0009981601; 0010041604; 0010148988; 0010172263; 0010172264;  Model Number/Description: ENVPRO-16-C/20FR DELIV SYS ENVPRO-16-C GTIN:00643169987319 Lot Numbers: 0009696941; 0009738986; 0009771779; 0009803583; 0009863079;  Model Number/Description: ENVPRO-16/20FR DELIV SYS ENVPRO-16 GTIN:00643169987265 Lot Numbers: 0009674371; 0009677038; 0009679691; 0009679692; 0009684327; 0009686569; 0009686570; 0009686571; 0009696942; 0009698697; 0009702500; 0009702503; 0009708312; 0009710331; 0009730832; 0009732862; 0009737236; 0009738987; 0009741278; 0009743439; 0009745281; 0009747814; 0009747815; 0009753924; 0009753927; 0009758219; 0009759084; 0009759087; 0009763374; 0009763376; 0009774179; 0009778375; 0009780302; 0009780305; 0009780307; 0009780310; 0009788694; 0009788696; 0009788699; 0009788700; 0009795297; 0009795298; 0009795299; 0009797643; 0009801628; 0009801631; 0009805724; 0009808236; 0009811908; 0009813676; 0009813677; 0009815903; 0009815905; 0009819799; 0009823654; 0009823655; 0009827179; 0009829369; 0009829370… (truncated, 7665 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Heart Valves Division
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 14, 2021

Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC

Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.

ALL 50 STATES
▸Full report

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

Recall #:
88200
Lot/product code:
Lots 12758314 and 13022357
Recalling firm:
Arthrex, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 14, 2021

Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19, RINX9999H19 The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs.

The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

ALL 50 STATES
▸Full report

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

Recall #:
88058
Lot/product code:
All Serial Numbers  Material Numbers: DSX9999H11 INX9999H19 RINX9999H19
Recalling firm:
Philips Respironics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 14, 2021

SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs.

The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

ALL 50 STATES
▸Full report

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

Recall #:
88058
Lot/product code:
All Serial Numbers  Material Numbers: AC250S AC550S AH250HS AH250S AH260HS AH260S AH260TS AH450HS AH450S AH550HS AH550S AH650HS AH650S AH750HS AH750S AU151HS AU151S AU251HS AU251S AU451HS AU451S AU551HS AU551S AU651HS AU651S AU751HS AU751S CA151HS CA151S CA251HS CA251S CA451HS CA451S CA551HS CA551S CA651HS CA651S CA751HS CA751S CN157HS CN157S CN257HS CN257S CN457HS CN457S CN557HS CN557S CN657HS CN657S CN757HS CN757S DE452HS DE452S DE552HS DE552S DE752HS DE752S DS150HS DS150S DS250HS DS250S DS450HS DS450S DS550HS DS550S DS650HS DS650S DS750HS DS750S FR355HS FR355S FR555HS FR555S HL454S HL554S IN151HS IN151S IN251HS IN251S IN451HS IN451S IN551HS IN551S IN651HS IN651S IN751HS IN751S JP256HS JP456HS JP456S JP556HS JP556S JP656HS JP756HS JP756S KP250HS KP250S KP450HS KP450S KP550HS KP550S KP750HS KP750S LA151HS LA151S LA251HS LA251S LA451HS LA451S LA551HS LA551S LA651HS LA651S LA751HS LA751S RIN551S RJP556S SH558HS SH558S UODS150S UODS250S UODS450S UODS550S UODS560S UODS650S UODS750S RTODS650HS 151BR LA151SBR 151P 157P 250P 251BR LA251SBR RBRLA251SBR 251P RBRLA251HS RBRLA251S 255P FR255HS FR255S 257P 355P 450P 451BR LA451SBR RBRLA451SBR 451P RIN451S RBRLA451HS RBRLA451S 452P UDE452S 454P 456P RJP456S 457P 550P 551BR LA551SBR RBRLA551SBR 551P RBRLA551HS RBRLA551S 552P UDE552S 554P 555P 556P 557P 651BR LA651SBR RBRLA651S RBRLA651SBR 651P 657P 750P 751BR LA751SBR RBRLA751SBR 751P RBRLA751HS RBRLA751S 752P 756P RJP756S 757P AU151H CA151 CA151H CA451HC CA451W CA551C CA551HC CN157 DS150 DS450C DS450D DS550C DS550HC KP450C KP450HC KP550C KP550HC RDS150S RDS250S RDS450S RDS520S RDS550HS RDS550S RDS650S RDS750HS RDS750S RIN751S UDS150S UDS250S UDS450S UDS520S UDS550S UDS650S UDS750S AHX200H11 AHX200H11C AHX200H11W AHX200S11 AHX200T11 AHX200T11C AHX200T11W AHX400H11 AHX400H11C AHX400H11W AHX400S11 AHX400T11 AHX400T11C AHX400T11W AHX500H11 AHX500H11C AHX500H11W AHX500S11 AHX500T11 AHX500T11C AHX500T11W AHX600H11 AHX600H11C AHX600H11W AHX600S11 AHX600T11 AHX600T11C AHX600T11W AHX700H11 AHX700H11C AHX700H11W AHX700S11 AHX700T11 AHX700T11C AHX700T11W ARX200H15 ARX200S15 ARX401H15 ARX401S15 ARX500H15 ARX500S15 ARX600H15 ARX600S15 ARX700H15 ARX700S15 AUX400H15 AUX400S15 AUX400T15 AUX400T15C AUX500H15 AUX500S15 AUX500T15 AUX500T15C AUX700H15 AUX700S15 AUX700T15 AUX700T15C BLX200H15 BLX200S15 BLX201S15 BLX201S15C BLX400H15 BLX400H15C BLX400S15 BLX400S15C BLX500H15 BLX500H15C BLX500H15MQ BLX500S15 BLX500S15C BLX600H15 BLX600S15 BLX700H15 BLX700S15 BRX200S18 BRX400S18 BRX404S18 BRX500S18 BRX504S18 BRX600S18 BRX700S18 CAX200H12 CAX200S12 CAX200T12 CAX400H12 CAX400H12C CAX400H12W CAX400S12 CAX400T12 CAX400T12C CAX400T12W CAX500H12 CAX500H12C CAX500H12W CAX500S12 CAX500S12C CAX500S12W CAX500T12 CAX500T12C CAX500T12W CAX501H12 CAX501H12C CAX501H12W CAX501T12 CAX501T12C CAX501T12W CAX600H12 CAX600H12C CAX600H12W CAX600S12 CAX600T12 CAX600T12C CAX600T12W CAX700H12 CAX700H12C CAX700H12W CAX700S12 CAX700S12C CAX700S12W CAX700T12 CAX700T12C CAX700T12W CNX200H17 CNX200T17 CNX400H17 CNX400T17 CNX500H17 CNX500T17 CNX600H17 CNX600T17 CNX700H17 CNX700T17 DEX400S13 DEX500S13 DEX700S13 DNX500H11C DNX500T11C DSX200H11 DSX200H11C DSX200H11W DSX200S11 DSX200S11C DSX200S11W DSX200T11 DSX200T11C DSX200T11W DSX400H11 DSX400H11C DSX400H11W DSX400S11 DSX400T11 DSX400T11C DSX400T11W DSX500H11 DSX500H11C DSX500H11CEP DSX500H11EP DSX500H11W DSX500H11WEP DSX500S11 DSX500S11C DSX500S11W DSX500T11 DSX500T11C DSX500T11CEP DSX500T11CMK DSX500T11EP DSX500T11W DSX500T11WEP DSX500T11WMK DSX600H11 DSX600H11C DSX600H11W DSX600S11 DSX600T11 DSX600T11C DSX600T11W DSX700H11 DSX700H11C DSX700H11CEP DSX700H11EP DSX700H11W DSX700H11WEP DSX700S11 DSX700S11C DSX700S11W DSX700T11 DSX700T11C DSX700T11CEP DSX700T11CMK DSX700T11EP DSX700T11W DSX700T11WEP DSX700T11WMK EEX200H15 EEX200S15 EEX400H15 EEX400S15 EEX401H15 EEX401S15 EEX500H15 EEX500S15 EEX600H15 EEX600S15 EEX700H15 EEX700S15 ESX200H15 ESX200S15 ESX201S15 ESX201S15C ESX400H15 ESX400S15 ESX401H15 ESX401H15C ESX401S15 ESX401S15C ESX401S15PR ESX500H15 ESX500H15C ESX500S15 ESX500S15C ESX600H15 ESX600S15 ESX700H15 ESX700S15 EUX200H15 EUX200S15 EUX400H15 EUX400S15 EUX401H15 EUX401S15 EUX500H15 EUX500S15 EUX600H15 EUX600S15 EUX700H15 EUX700S15 FRX400S14 FRX400S14W FRX401S14 FRX500S14 FRX500S14W FRX501H14W FRX501S14 FRX501S14W FRX700S14 FRX700S14W GBX200H15 GBX200S15 GBX400H15 GBX400S15 GBX401H15 GBX401S15 GBX500H15 GBX500S15 GBX600H15 GBX600S15 GBX700H15 GBX700S15 INX200H15 INX200S15 INX200T15 INX400H15 INX400S15 INX400T15 INX500H15 INX500S15 INX500T15 INX600H15 INX600S15 INX600T15 INX700H15 INX700S15 INX700T15 ITX200H15 ITX200S15 ITX400H15 ITX400H15W ITX400S15 ITX500H15 ITX500H15W ITX500S15 ITX600H15 ITX600S15 ITX700H15 ITX700S15 JPX400S16 JPX400S16C JPX500S16 JPX500S16C JPX501S16 JPX700S16 JPX700S16C KRX200H15 KRX200S15 KRX200T15 KRX400H15 KRX400S15 KRX400T15 KRX500H15 KRX500S15 KRX500T15 KRX600H15 KRX600S15 KRX600T15 KRX700H15 KRX700S15 KRX700T15 LAX200H15 LAX200S15 LAX200T15 LAX400H15 LAX400S15 LAX400T15 LAX500H15 LAX500S15… (truncated, 6805 characters total — see the official FDA record for the full value)
Recalling firm:
Philips Respironics, Inc.
View official FDA record (opens in a new tab)