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Recalls affecting Kansas

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

16,717 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 29, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-36-XX, Novation GXL Liner, +5mm Lateralized, 36mm. Orthopedic hip implant component.

Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

ALL 50 STATES
▸Full report

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

Recall #:
88126
Lot/product code:
All serial numbers. UDI-DI numbers: 10885862024329, 10885862024336, 10885862024343, 10885862024350
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 29, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-28-XX, Acumatch GXL 0 Degree Liner, 28mm; Novation GXL Liner, Neutral, 28mm; and Novation GXL Neutral Liner, G0, 28mm ID. Orthopedic hip implant component.

Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

ALL 50 STATES
▸Full report

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

Recall #:
88126
Lot/product code:
All serial numbers. UDI-DI numbers: 10885862021984, 10885862021991, 10885862022004, 10885862022011, 10885862022028, 10885862022035, 10885862022059, 10885862022066, 10885862022073
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 29, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, Novation GXL 10 deg Liner, G00, 22mm ID. Orthopedic hip implant component.

Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

ALL 50 STATES
▸Full report

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

Recall #:
88126
Lot/product code:
All serial numbers. UDI-DI number: 10885862024503
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 29, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-36-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.

Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

ALL 50 STATES
▸Full report

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

Recall #:
88126
Lot/product code:
All serial numbers. UDI-DI numbers: 10885862013682, 10885862013699, 10885862013705, 10885862013712, 10885862013729
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 29, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-32-XX, Novation GXL Liner, +5mm Lateralized, 32mm. Orthopedic hip implant component.

Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

ALL 50 STATES
▸Full report

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

Recall #:
88126
Lot/product code:
All serial numbers. UDI-DI numbers: 10885862024275, 10885862024282, 10885862024299, 10885862024305, 10885862024312
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 29, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-28-XX, Novation GXL Liner, +5mm Lateralized, 28mm; and Novation GXL Liner, +5mm Lateralized, G0, 22mm ID. Orthopedic hip implant component.

Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

ALL 50 STATES
▸Full report

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

Recall #:
88126
Lot/product code:
All serial numbers. UDI-DI numbers: 10885862024213, 10885862024220, 10885862024237
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 29, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, Acumatch GXL 15 Degree Liner, 32mm; Novation GXL Liner, Lipped Ant, 32mm; and Novation GXL Liner, Lipped, 32mm. Orthopedic hip implant component.

Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

ALL 50 STATES
▸Full report

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

Recall #:
88126
Lot/product code:
All serial numbers. UDI-DI numbers: 10885862023247, 10885862023254, 10885862023261, 10885862023278, 10885862207029, 10885862023315, 10885862023322, 10885862023339, 10885862023346, 10885862303325, 10885862303417, 10885862303424, 10885862303431, 10885862303448
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 29, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 134-28-XX, Acumatch GXL, Ext Cov Liner, 28mm. Orthopedic hip implant component.

Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

ALL 50 STATES
▸Full report

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

Recall #:
88126
Lot/product code:
All serial numbers. UDI-DI numbers: 10885862023919, 10885862023926, 10885862023933, 10885862023940, 10885862023957, 10885862023964
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 29, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-40-XX, Novation GXL Liner, +5mm Lateralized, 40mm. Orthopedic hip implant component.

Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

ALL 50 STATES
▸Full report

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

Recall #:
88126
Lot/product code:
All serial numbers. UDI-DI numbers: 10885862220301, 10885862220318, 10885862220325
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 29, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-36-XX, Acumatch GXL 15 Degree Liner, 36mm, and Novation GXL Liner, Lipped Ant, 36mm; and Novation GXL Liner, Lipped, 36mm. Orthopedic hip implant component.

Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

ALL 50 STATES
▸Full report

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

Recall #:
88126
Lot/product code:
All serial numbers. UDI-DI numbers: 10885862023384, 10885862023391, 10885862023407, 10885862023414, 10885862023421, 10885862023438, 10885862023445, 10885862303332, 10885862303455, 10885862303462, 10885862303479
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 29, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation GXL Liner, Neutral, 40mm. Orthopedic hip implant component.

Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

ALL 50 STATES
▸Full report

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

Recall #:
88126
Lot/product code:
All serial numbers. UDI-DI numbers: 10885862207098, 10885862207104, 10885862207111
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 29, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-22-XX, Novation GXL Neutral Liner, G00, 22mm ID. Orthopedic hip implant component.

Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

ALL 50 STATES
▸Full report

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

Recall #:
88126
Lot/product code:
All serial numbers. UDI-DI number: 10885862021892
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 29, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-22-XX, Novation GXL Liner, +5mm Lateralized, G00, 22mm ID. Orthopedic hip implant component.

Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

ALL 50 STATES
▸Full report

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

Recall #:
88126
Lot/product code:
All serial numbers. UDI-DI number: 10885862024190
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 29, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.

Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

ALL 50 STATES
▸Full report

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

Recall #:
88126
Lot/product code:
All serial numbers. UDI-DI numbers: 10885862013491, 10885862013507, 10885862013514, 10885862013521, 10885862013538, 10885862013545, 10885862013569, 10885862013576, 10885862013583
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 29, 2021

Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.

Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5).

ALL 50 STATES
▸Full report

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

Recall #:
88259
Lot/product code:
Serial Numbers: 6465619-6465640; 6465642-6465648
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 29, 2021

Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.

Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5).

ALL 50 STATES
▸Full report

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

Recall #:
88259
Lot/product code:
Serial Numbers: 6465589-6465618; 6465641
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 29, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation GXL Liner, 10 Deg Face, 32mm. Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-36-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 36mm, Novation GXL Liner, 10 Deg Face, 36mm. (note: inadvertently left out of original posting) Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-40-XX, Novation GXL Liner, 10 Deg Face, 20mm ID. (note: inadvertently left out of original posting) Orthopedic hip implant component.

Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

ALL 50 STATES
▸Full report

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

Recall #:
88126
Lot/product code:
All serial numbers. UDI-DI numbers: 138-32-XX: 10885862024732, 10885862024749, 10885862024756, 10885862024763, 10885862024770. 138-36-XX: 10885862024817, 10885862024824, 10885862024831, 10885862024848, 10885862024886, 10885862024893, 10885862024909, 10885862024916. 138-40-XX: 10885862208804, 10885862208811, 10885862208828.
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 29, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-32-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.

Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

ALL 50 STATES
▸Full report

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

Recall #:
88126
Lot/product code:
All serial numbers. UDI-DI numbers: 10885862013606, 10885862013613, 10885862013620, 10885862013637, 10885862013644, 10885862013651, 10885862013668, 10885862013675
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 29, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, 22mm ID; and Novation GXL Liner, Lipped Ant, 28mm. Orthopedic hip implant component.

Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

ALL 50 STATES
▸Full report

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

Recall #:
88126
Lot/product code:
All serial numbers. UDI-DI numbers: 10885862303370, 10885862022967
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 29, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm; Novation GXL Liner, G0, 28mm ID; Novation GXL Liner, Lipped Ant, 28mm; and Novation GXL Liner, Lipped, 28mm. Orthopedic hip implant component.

Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

ALL 50 STATES
▸Full report

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

Recall #:
88126
Lot/product code:
All serial numbers. UDI-DI numbers: 10885862023063, 10885862023070, 10885862023087, 10885862023094, 10885862023100, 10885862023117, 10885862023124, 10885862023148, 10885862023155, 10885862023162, 10885862303387, 10885862303394, 10885862303400
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 30, 2021

Revolution CT, Revolution CT ES

The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.

ALL 50 STATES
▸Full report

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

Recall #:
89762
Lot/product code:
Revolution CT, Revolution CT ES
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 30, 2021

The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further, the images can be post processed to produce additional imaging planes or analysis results. The system is indicated for head, whole body, cardiac, and vascular X-ray Computed Tomography applications. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition.

ALL 50 STATES
▸Full report

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

Recall #:
88208
Lot/product code:
Revolution CT
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 30, 2021

Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition

The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table height is adjusted after the exam starts. In this situation, the SmartStep display will show a value that is higher (up to 100 times) than the actual dose delivered.

ALL 50 STATES
▸Full report

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

Recall #:
89027
Lot/product code:
Revolution CT,  Revolution CT ES,  Revolution Apex,  Revolution CT with Apex edition
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 30, 2021

The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports components and accessories. This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further, the images can be post processed to produce additional imaging planes or analysis results. The system is indicated for head, whole body, cardiac, and vascular X-ray Computed Tomography applications. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition.

ALL 50 STATES
▸Full report

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

Recall #:
88208
Lot/product code:
Revolution CT
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 30, 2021

The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either withor without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results. The system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition.

ALL 50 STATES
▸Full report

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

Recall #:
88208
Lot/product code:
Revolution CT
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)