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Recalls affecting Alaska

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

16,247 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

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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

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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 August 5, 2021

Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
▸Full report

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

Recall #:
88499
Lot/product code:
Catalog A303318A, Lot NGEVX105, UDI (01)00801741073809(17)201220(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
▸Full report

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

Recall #:
88499
Lot/product code:
Catalog A800361, Lots: NGFR0310, UDI (01)00801741073939(17)201220(10); NGFR0311,UDI N(01)00801741073939(17)201220(10); GFR2807, UDI (01)00801741073939(17)201220(10); NGFR2829, UDI (01)00801741073939(17)201220(10); NGFR3571, UDI (01)00801741073939(17)201220(10); NGFR5475, UDI (01)00801741073939(17)201220(10); nd NGFR5481 UDI (01)00801741073939(17)201220(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabilization Device

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
▸Full report

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

Recall #:
88499
Lot/product code:
Catalog A897514, Lot NGFR2808, UDI (01)00801741104510(17)201228(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
▸Full report

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

Recall #:
88499
Lot/product code:
Catalog A300314A, Lot NGFR3627, UDI (01)00801741073724(17)201228(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
▸Full report

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

Recall #:
88499
Lot/product code:
Catalog A119216M; Lots NGFR2561, UDI (01)00801741073687(17)201228(10)  and NGFS1312, UDI (01)00801741073687(17)201228(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, StatLock" Stabilization Device

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
▸Full report

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

Recall #:
88499
Lot/product code:
Catalog A902416, Lot NGFR4567, UDI (01)00801741074042(17)201228(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
▸Full report

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

Recall #:
88499
Lot/product code:
Catalog A902616, Lot NGFR3277, UDI (01)00801741104633(17)251228(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
▸Full report

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

Recall #:
88499
Lot/product code:
Catalog A300318A, Lot NGEVX106, UDI (01)00801741073748(17)201228(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
▸Full report

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

Recall #:
88499
Lot/product code:
Catalog A300316A, Lots: NGEVX104 (exp. 08/31/2022), UDI (01)00801741073731(17)201228(10); NGFR3628 (02/28/2023), UDI (01)00801741073731(17)201228(10); GFS1114 (02/28/2023), UDI (01)00801741073731(17)201228(10); and NGFS1166 (02/28/2023), UDI (01)00801741073731(17)201228(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
▸Full report

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

Recall #:
88499
Lot/product code:
Catalog A303316A, Lots: NGEVX103 (exp. 08/31/2022), UDI (01)00801741073793(17)201220(10); NGFR3290 (02/28/2023), UDI (01)00801741073793(17)201220(10); NGFR3291 (exp. 02/28/2023), UDI (01)00801741073793(17)201220(10); and NGFR4542 (exp. 02/28/2023) UDI (01)00801741073793(17)201220(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
▸Full report

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

Recall #:
88499
Lot/product code:
Catalog A902916, Lots: NGFR3115, UDI (01)00801741074073(17)251228(10); NGFR3278, UDI (01)00801741074073(17)251228(10); NGFR3279, UDI (01)00801741074073(17)251228(10);  NGFS1308, UDI (01)00801741074073(17)251228(10); NGFS1309, UDI (01)00801741074073(17)251228(10); and NGFS1366, UDI (01)00801741074073(17)251228(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock" Stabilization Device

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
▸Full report

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

Recall #:
88499
Lot/product code:
Catalog A942216, Lot NGFS3274, UDI (01)00801741074110(17)201228(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
▸Full report

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

Recall #:
88499
Lot/product code:
Catalog A319516AM, Lot NGFS1691, UDI (01)00801741073892(17)201228(10);  NGFR3282, UDI (01)00801741073892(17)201228(10); and NGFR4423, UDI (01)00801741073892(17)201228(10)  Expanded 10/8/2021 adding Lot NGFS1691 UDI (01)00801741073892(17)201228(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
▸Full report

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

Recall #:
88499
Lot/product code:
Catalog A319416AM, Lots NGEVX107 (exp. 08/31/2022), UDI (01)00801741073861(17)201220(10); NGFR3116 (exp. 02/28/2023), UDI (01)00801741073861(17)201220(10); and NGFS1808 (02/28/2023) UDI (01)00801741073861(17)201220(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
▸Full report

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

Recall #:
88499
Lot/product code:
Catalog A800061, Lot NGFR3658, UDI (01)00801741104848(17)251228(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
▸Full report

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

Recall #:
88499
Lot/product code:
Catalog A303416A, Lot NGFS1844, UDI (01)00801741073823(17)201228(10); NGFS1845, UDI (01)00801741073823(17)201228(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
▸Full report

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

Recall #:
88499
Lot/product code:
Catalog A800360, Lot NGFR3570, UDI (01)00801741073922(17)251228(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 6, 2021

NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129

There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.

ALL 50 STATES
▸Full report

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

Recall #:
88455
Lot/product code:
Model H-1100: Product Codes CON-H1100, H-1100, H-1100-ES-115V, H-1100-ES-230V, H-1100-FR-230V, H-1100-INT-230, H-1100-IT-230V, H-1100-NL-230V H-1100-SV-230V, H-1100-UK-230  Model H-1129: Product Code H-1129
Recalling firm:
Smiths Medical ASD Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 6, 2021

EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205 EPIQ 5G - 795204 EPIQ 7 - 795117 EPIQ 7C - 795201 EPIQ 7G - 795200 EPIQ CVxi -795232 EPIQ CVx - 795231

Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.

ALL 50 STATES
▸Full report

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

Recall #:
88514
Lot/product code:
EPIQ Diagnostic Ultrasound Systems: EPIQ 5 Model Number: 795120 Serial Numbers/UDI Codes US118C0391/ (01)00884838047686(21)US118C0391; US118C1388/ (01)00884838047686(21)US118C1388; US118C1389/ (01)00884838047686(21)US118C1389; US119C0516/ (01)00884838047686(21)US119C0516; US119C0517/ (01)00884838047686(21)US119C0517; US119C0644/ (01)00884838047686(21)US119C0644; US121C0839/ (01)00884838047686(21)US121C0839; US219C0823/ (01)00884838047686(21)US219C0823; US219C0949/ (01)00884838047686(21)US219C0949; US319C0210/ (01)00884838047686(21)US319C0210; US518C1519/ (01)00884838047686(21)US518C1519; US518C1528/ (01)00884838047686(21)US518C1528; US719C0285/ (01)00884838047686(21)US719C0285; US719C0603/ (01)00884838047686(21)US719C0603; US918C0543/ (01)00884838047686(21)US918C0543; US918C1811/ (01)00884838047686(21)US918C1811; USD18C1243/ (01)00884838047686(21)USD18C1243; EPIQ 5C Model Number: 795205 Serial Numbers/UDI Codes US114C0239/ N/A; US114C0240/ N/A; US114C0241/ N/A; US114C0271/ N/A; US114C0272/ N/A; US114C0286/ N/A; US114C0287/ N/A; US114C0308/ N/A; US114C0366/ N/A; US117C0337/ (01)00884838047686(21)US117C0337; US215C0536/ N/A; US315C0582/ N/A; US316C0339/ N/A; US414C0158/ N/A; US514C0541/ N/A; US614C0745/ N/A; US614C0854/ N/A; US615C1170/ N/A; US615C1171/ N/A; US615C1172/ N/A; US617C0803/ (01)00884838047686(21)US617C0803; US617C0882/ (01)00884838047686(21)US617C0882; US715C0376/ N/A; US716C0748/ N/A; US717C0579/ (01)00884838047686(21)US717C0579; US815C1244/ N/A; US816C1004/ (01)00884838047686(21)US816C1004; US816C1005/ (01)00884838047686(21)US816C1005; US816C1031/ (01)00884838047686(21)US816C1031; US816C1089/ (01)00884838047686(21)US816C1089; US818C1155/ (01)00884838047686(21)US818C1155; US818C1156/ (01)00884838047686(21)US818C1156; US914C0244/ N/A; US914C0246/ N/A; US914C0998/ N/A; USD13C0525/ N/A; USD13C0526/ N/A; USD13C0527/ N/A; USD13C0615/ N/A; USD13C0616/ N/A; USD13C0617/ N/A; USD13C0618/ N/A; USD13C0619/ N/A; USD13C0620/ N/A; USD13C0621/ N/A; USD13C0670/ N/A; USD13C0671/ N/A; USD13C0709/ N/A; USD14C0168/ N/A; USD14C0370/ N/A; USD14C0371/ N/A; USD18C0387/ (01)00884838047686(21)USD18C0387; USO13C0369/ N/A; USO13C0398/ N/A; USO13C0532/ N/A; USO13C0536/ N/A; USO16C0440/ (01)00884838047686(21)USO16C0440; USO17C1366/ (01)00884838047686(21)USO17C1366; USO17C1367/ (01)00884838047686(21)USO17C1367; USO17C1368/ (01)00884838047686(21)USO17C1368; EPIQ 5G Model Number: 795204 Serial Numbers/UDI Codes US114C0321 N/A US114C0534 N/A US116C0562 N/A US116C0725 N/A US117C0310 (01)00884838047686(21)US117C0310 US117C0816 (01)00884838047686(21)US117C0816 US117C0819 (01)00884838047686(21)US117C0819 US117C0864 (01)00884838047686(21)US117C0864 US117C1215 (01)00884838047686(21)US117C1215 US118C0677 (01)00884838047686(21)US118C0677 US118C0678 (01)00884838047686(21)US118C0678 US118C0679 (01)00884838047686(21)US118C0679 US118C0680 (01)00884838047686(21)US118C0680 US118C0682 (01)00884838047686(21)US118C0682 US119C0380 (01)00884838047686(21)US119C0380 US119C0686 (01)00884838047686(21)US119C0686 US119C0687 (01)00884838047686(21)US119C0687 US119C0688 (01)00884838047686(21)US119C0688 US120B0893 (01)00884838088658(21)US120B0893 US120B0919 (01)00884838088658(21)US120B0919 US120B0922 (01)00884838088658(21)US120B0922 US120B0923 (01)00884838088658(21)US120B0923 US120B0927 (01)00884838088658(21)US120B0927 US120B0928 (01)00884838088658(21)US120B0928 US120B0929 (01)00884838088658(21)US120B0929 US120B0930 (01)00884838088658(21)US120B0930 US120B0931 (01)00884838088658(21)US120B0931 US120B0932 (01)00884838088658(21)US120B0932 US120B0933 (01)00884838088658(21)US120B0933 US120B0938 (01)00884838047693(21)US120B0938 US120C0083 (01)00884838047686(21)US120C0083 US120C0115 (01)00884838047686(21)US120C0115 US120C0116 (01)00884838047686(21)US120C0116 US120C0117 (01)00884838047686(21)US120C0117 US120C0193 (01)00884838047686(21)US120C0193 US120C0196 (01)00884838047686(21)US120C0196 US120C0274 (01)00884838047686(21)US120C0274 US120C0278 (01)00884838047686(21)US120C0278 US120C0279 (01)00884838047686(21)US120C0279 US120C0281 (01)00884838047686(21)US120C0281 US120C0282 (01)00884838047686(21)US120C0282 US120C0283 (01)00884838047686(21)US120C0283 US120C0353 (01)00884838047686(21)US120C0353 US120C0354 (01)00884838047686(21)US120C0354 US120C0355 (01)00884838047686(21)US120C0355 US120C0407 (01)00884838047686(21)US120C0407 US120C0408 (01)00884838047686(21)US120C0408 US120C0409 (01)00884838047686(21)US120C0409 US120C0410 (01)00884838047686(21)US120C0410 US120C0411 (01)00884838047686(21)US120C0411 US120C0464 (01)00884838047686(21)US120C0464 US120C0465 (01)00884838047686(21)US120C0465 US120C0498 (01)00884838047686(21)US120C0498 US120C0499 (01)00884838047686(21)US120C0499 US120C0501 (01)00884838047686(21)US120C0501 US120C0502 (01)00884838047686(21)US120C0502 US120C0503 (01)00884838047686(21)US120C0503 US120C0504 (01)00884838047686(21)US120C0504 US120C0505 (01)00884838047686(21)US120C0505 US120C0582 (01)00884838047686(21)US120C0582 US120C0583 (01)00884838047686(21)US120C… (truncated, 252668 characters total — see the official FDA record for the full value)
Recalling firm:
Philips Ultrasound Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 6, 2021

Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources. Includes the following Model Numbers: 1. Model Number: 2090255-001; 2. Model Number: 2088026-723; 3. Model Number: 2102676-001; 4. Model Number: 2104867-044.

Image acquisition failures and synchronization failure with the Centricity Enterprise Archive

AKAZCACODEFLGAIAINLAMAMDMIMNMOMSMTNCNDNJNMNVNYOHOKORPASDTXUTWAWIWVWY
▸Full report

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

Recall #:
88526
Lot/product code:
1. Model Number: 2090255-001 (Centricity Universal Viewer with PACS-IW foundation software versions 6.0 through 6.0 SP7.1) System ID (UDI-DI if applicable): PMIO14194768, PMIO20084199, PACS-IW-231, CITRUSVAL20884363, CITRUSVAL20884364, CITRUSVAL20884365, PACS-IW-155, PRIMEHEAL02315681, PRIMEHEAL20501355, PARKVIEWC21200827 (840682103800), PARKVIEWC21200830 (840682103800), PACS-IWUVN2-441, QUEEN19630914, QUEEN19630915, QUEEN19630916T, QUEEN20553950, 203268UVSW, DELAWAREC01589220, PACS-IW-462UV, PACS-IW-462UVN1, PACS-IW-126, PACS-IW-1062, OFMC01819402, OFMC20791988, HGS01766912, HGS20584004 (840682103800), GA001PACTRL01, TRGI02180958, DRY01810490, DRY19670358, PACS-IW-101, RML20502096, PACS-IWUV-239, PACS-IW-00813, PHS01374810, 01722652SEAS, 02031921SEASN1, MARYLANDF17985489, MYRTLEHIL17713895, MYRTLEHIL01444483, MYRTLEHIL17713895, VT01766830, VT01977629, PACS-IW-2637, SRMC01982629, PACS-IWUV-568, 1-142022244, PACS-IWUV-1131, OGAA02373799NOD1, ALLG00558571 (840682103800), EXC02189547, EXC01584099, PACS-IW-574, PRIME HEAL19508102, PRIME HEAL19050922, PRIME HEAL19050921, PACS-IW-219, ANCL00558570, ANCL02157634, NSW01452088, NSW20080545, MARYLANDF17985489, PACS-IW-518UV (840682103800), MTGD02393053, MTGD00558454, PACS-IW-44, QUENTIN01970717, LAKESIDEM02256808, BMC12P00558644P1, BMC12T02267839, BMC12N01271417N1, PACS-IW-58, SMCO02039946PC (840682103800), BWH01301357, PACS-IW-349, PACS-IW-255, 1-357059471, CAROCOMMU02205222, CAROCOMMU01459013, CSPA01291589 (840682103800), CSPA02097167 (840682103800), PACS-IW-79, PACS-IW-93, 1-276423210, MFCI01448329, LSFH02032334, CORONAREG01300927, 951737IWUWWN1, CORONAREG02288447, 1-382753509, CITRUSVAL19618406, MGMC02288391, MGMC02398531, 1-473998727, BARRETTHO00558704, BARRETTHO17737529, FORTDUNCA01298556 (840682103800), FORTDUNCA02395799 (840682103800), 1-283597082, TTU01973509, AVHL02396030, PACS-IW-511, PACSIWTEST, PACS-IW-386UV (840682103800), PACS-IW-486-UV (840682103800), PACS-IW-486-UVN1 (840682103800), PACS-IW-390 (840682103800), PACS-IW-202TEST, PACS-IW-202, HZC14961014, AVHL02396026, AVHL02396027, AVHL02396028, AVHL02396029, PACS-IW-419, PMRM14768587UVProxy, HANNIBALR02179353 (840682103800), TESTHANNIBALR02255613 (840682103800), HANN16174584UVProxy (840682103800), PACS-IW-189 (840682103800), HARTSDALE14768195 (840682103800), HOA01451973 (840682103800), RML01448365 (840682103800), ICA01367198 (840682103800), ICA14776604 (840682103800), JKS01452133 (840682103800), JKS14776447UVSFNode (840682103800), JKS14776448UVProxy (840682103800), JKS14776449UVTest (840682103800), PACS-IW-181, GTEC01477448, GTEC01477447, GTEC15993728UVProxy3, 1-592001096 (840682103800), UHSD14767800 (840682103800), PACS-IW-551UVN1 (840682103800), PACS-IW-551UVN2 (840682103800), UV1-154550926, DHOL19603374, DHOL19603375, PACS-IW-551UV (840682103800), PACS-IW-424CTLR, PACS-IW-424UVN1, PACS-IW-424UVN2, SFCS19667347, SFCS15961473, SFCS15961473, MHOG01806096, PACS-IW-166, PACS-IW-166T, MCT02277843, MCT02278145, PACS-IW-565, PACS-IWT-565, WGH00558334CTRL, WGH02372377PROX, WGH02372375BACK, 1-464783615, PACS-IW-389, BVH00558643, PACS-IW-348UV (840682103800), NRVM19609993UVT (840682103800), NRVM19611189UVPROXY (840682103800), PACS-IW-441, PACS-IW-441TUVSW, PACS-IW-402, PACS-IW-318, MINNETOHE, PACS-IW-253, PACS-IW-581UV, PACS-IW-370, PACS-IW-UVT370, VISOU02345023, VISOU02288781, 1-218291079, 1-103108035, MFHO14767332, PALMDALEM00558700, PALMDALEM01810788, PACS-IW-454, PACS-IW-406, 20101378UBSW, ILCC01373579 (840682103800), ILCC14580319 (840682103800), 516473UVSW (840682103800), JOHNTMA19732280T (840682103800), 1-182669905, NCDC20279342, CENTERFOR01627896, CENTERFOR16023960UVProxy, PACS-IW-176, PACS-IW-176UVTEST, PACS-IW-405, PACS-IW-336, NASONHOSP14898835, RRA01814001, MYRTLEHIL01444483, PSPC01815255, 1-283596904, HOOO20091140, GZMG02182469CNTRLR (840682103800), GZMG02287985 (840682103800), GZMG02288300 (840682103800), PACS-IW-556UV, URSA20025013, PACS-IW-431, 1-598891598, PACS-IW-230, INTERCOAST17594527UVProxy, MDHC16204735UVProxy, 201392UVSW, 505368UVBSW (840682103800), NNAR14767799 (840682103800), PACS-IW-479, PACS-IW-557 (840682103800), URS20583582 (840682103800), PACS-IWUV-481, PACS-IW-476, PACSIW476UVTEST, GGMC02349137, 1-486091448, 1-486091475, 1-750710672, SUC00558667, 1-802428413, 954688UVBSW100, PACS-IW-1511, KDH217192544, ACP00558109, PACS-IW-31Test1, PACS-IW-31Test, ACP01613226, 1-219095008, OKOS14767330, 918277CVUWBSW, CCA20759776SF, PACS-IW-487, QTHBL14767810UVPROXY, QTHBL14767809UVSFBK, QTHBL14767808UVSF1KO, QTHBL14767807UVSFSIM, QTHBL14767806UVSFVAL, QTHBL02256595, VCM02255583T, VCM01819618, VCM02255586TSP, VMC02255587NSP, BOJC00558520, PACS-IW-56, PACS-IW-225, 1-375705893, DDNI14776603, PACS-IW-129, DISSFHW01, 1-644600677, PACS-IW-154UV, FLMC14777071, NEWYORK01291738, OANT02035061, PACS-IW-424CTLR, PACS-IW-424UVN1, PACS-IW-424UVN2, VBHCP20497227, PACS-IW-2635, PREMI02182462, PREMI02182462, NORTHWEST01804127, HCIT4271649UW, AH4325SV01, AH5291PC02, AP6264PC01, AP6469PC01, AH0116SV03, AH0106SV0… (truncated, 7572 characters total — see the official FDA record for the full value)
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 6, 2021

Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.

Image acquisition failures and synchronization failure with the Centricity Enterprise Archive

AKAZCACODEFLGAIAINLAMAMDMIMNMOMSMTNCNDNJNMNVNYOHOKORPASDTXUTWAWIWVWY
▸Full report

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

Recall #:
88526
Lot/product code:
2068177-001 (Centricity PACS-IW with Universal Viewer software versions 5.0.x with PACS-IW foundation) System ID: 083055248481416, 1-121967267, 1-429329281, DGC19607785, HC3062UV01, HCIT1401012UW, HCIT4331279UV, PACS-IW-127, PACS-IW-219, PACS-IW-2770, PACS-IW-323, PACS-IW-421, RICHMONDU14767331, RICHMONDU15531177N1, X1347906 / X1347909, X1347906 / X1347909, YP315021, ZA2412PAC21 and ZA2533PAC1
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 6, 2021

NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700

There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.

ALL 50 STATES
▸Full report

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

Recall #:
88455
Lot/product code:
Model IR-40: Product Code IR-40   Model IR-500: Product Code IR-500   Model IR-600: Product Code IR-600   Model IRI-600: Product Code IRI-600   Model IRI-600B: Product Code IRI-600B   Model IR-700: Product Code IR-700
Recalling firm:
Smiths Medical ASD Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 6, 2021

Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affiniti 30 795218 Affiniti 50 795208 Affiniti 50 795118 Affiniti 70 795210 Affiniti 70 795119

Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.

ALL 50 STATES
▸Full report

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

Recall #:
88514
Lot/product code:
Afiniti Diagnostic Ultrasound Systems: Affiniti 30 Model Number: 795121 Serial Numbers/UDI Codes US219E1452 (01)00884838074187(21)US219E1452 US220E0262 (01)00884838074187(21)US220E0262 US320E1098 (01)00884838074187(21)US320E1098 US320E1099 (01)00884838074187(21)US320E1099 US918E0145 (01)00884838074187(21)US918E0145 USN18E0607 (01)00884838074187(21)USN18E0607 USN18E1617 (01)00884838074187(21)USN18E1617 USN19E2219 (01)00884838074187(21)USN19E2219 USN19E2220 (01)00884838074187(21)USN19E2220 USN19E2221 (01)00884838074187(21)USN19E2221 Affiniti 30 Model Number: 795218 Serial Numbers/UDI Codes PU220E1330 N/A PU220E1331 N/A PU220E1332 N/A PU220E1333 N/A PU220E1334 N/A PU220E1335 N/A PU420E0442 N/A PU420E0658 N/A PU420E0659 N/A PU420E0660 (01)00884838097957 PU420E0761 (01)00884838074187 PU520E0703 (01)00884838074187 PU520E0713 N/A PU520E0854 (01)00884838074187 PU520E0855 N/A PU520E0856 N/A PU520E0857 N/A PU520E0858 N/A PU520E0859 N/A PU520E0861 N/A PU520E0965 N/A PU520E0966 N/A PU520E0967 N/A PU520E0968 N/A PU520E1012 N/A PU520E1013 (01)00884838074187 PU520E1014 (01)00884838074187 PU520E1015 N/A PU520E1016 N/A PU520E1017 (01)00884838074187 PU520E2820 (01)00884838097957 PU520E2821 (01)00884838097957 PU520E2831 (01)00884838097957 PU620E0090 (01)00884838097957 PU720E0464 (01)00884838074187 PU720E0468 N/A PU720E0611 (01)00884838097957 PU720E0800 (01)00884838097957 PU720E0801 (01)00884838097957 PU720E0803 N/A PU720E0804 N/A PU820E0248 N/A PU820E0249 N/A PU820E0347 (01)00884838097957 PU820E0349 N/A PU820E0525 N/A PU820E0526 N/A PU820E0535 N/A PU820E0536 N/A PU820E0540 N/A PU820E0541 N/A PU820E0544 (01)00884838074187 PU820E0545 N/A PU820E0654 (01)00884838074187 PUD19E0772 N/A PUD19E0832 N/A PUD19E0833 N/A US117E1004 (01)00884838074187(21)US117E1004 US118E1385 (01)00884838074187(21)US118E1385 US119E0798 (01)00884838074187(21)US119E0798 US119E0912 (01)00884838074187(21)US119E0912 US119E1661 (01)00884838074187(21)US119E1661 US119E1662 (01)00884838074187(21)US119E1662 US120E0309 (01)00884838074187(21)US120E0309 US120E0310 (01)00884838074187(21)US120E0310 US120E0340 (01)00884838074187(21)US120E0340 US120E0341 (01)00884838074187(21)US120E0341 US120E0342 (01)00884838074187(21)US120E0342 US120E0448 (01)00884838074187(21)US120E0448 US120E0449 (01)00884838074187(21)US120E0449 US120E0507 (01)00884838074187(21)US120E0507 US120E0630 (01)00884838074187(21)US120E0630 US120E0651 (01)00884838074187(21)US120E0651 US120E0652 (01)00884838074187(21)US120E0652 US120E0653 (01)00884838074187(21)US120E0653 US120E0654 (01)00884838074187(21)US120E0654 US120E0655 (01)00884838074187(21)US120E0655 US120E0656 (01)00884838074187(21)US120E0656 US120E0657 (01)00884838074187(21)US120E0657 US120E0719 (01)00884838074187(21)US120E0719 US120E0720 (01)00884838074187(21)US120E0720 US120E0721 (01)00884838074187(21)US120E0721 US120E0722 (01)00884838074187(21)US120E0722 US120E0723 (01)00884838074187(21)US120E0723 US120E0724 (01)00884838074187(21)US120E0724 US120E0778 (01)00884838074187(21)US120E0778 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US120E1610 (01)00884… (truncated, 163251 characters total — see the official FDA record for the full value)
Recalling firm:
Philips Ultrasound Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 6, 2021

Medtronic HVAD Pump Implant Kits

There is more force required to slide the driveline cover (boot cover) away from the connector after completion of a Driveline Strain Relief Repair than over an unrepaired strain relief. This may lead to difficulty in pulling back the driveline cover when attempting to access the Driveline connector during a controller exchange. Additionally, sliding the driveline cover over a strain relief repair may compromise the repair.

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▸Full report

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

Recall #:
88541
Lot/product code:
Product Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU - all serial numbers
Recalling firm:
Heartware, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 9, 2021

DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955)

There is a potential for open seals which can compromise sterility.

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▸Full report

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

Recall #:
88460
Lot/product code:
ICC 187660 - Lots 9B02984Y, 9G04308, 9K05775, 9L00556, 0A03460, and 9A04124Y ICC 187957 - Lots 9J02859, 9H02226, 9H04865, 9L02456 ICC 187955 - Lots 9L01731, 9L04890, 9K02656, 9H01234, 9M01779, and 9H00183
Recalling firm:
ConvaTec, Inc
View official FDA record (opens in a new tab)