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Recalls affecting Nebraska

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

16,488 recalls found

Just announced

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

Business Pill, Branch Manager for Mendietary 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 AliveMoringa 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. Braun0.9% 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 ValueOrganic 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 TemptationsChocolatey 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

LipofitLipofit 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

KofinasGarlic 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 SproutsRobust 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

MartinaMangoes

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 21, 2021

WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

ALL 50 STATES
Full report

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

Recall #:
88234
Lot/product code:
a) REF PIVD2010W, Lot 1100256 b) REF PIV2210W, Lot 1100316 c) REF PIV2475W, Lot 1200084
Recalling firm:
Delta Med SpA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 21, 2021

DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

ALL 50 STATES
Full report

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

Recall #:
88234
Lot/product code:
a) REF 3836272, Lot 11T80188 b) REF 3814272, Lot 11T80272 c) REF 3845272, Lot 12T80147 d) REF 3856272, Lot 12T80347
Recalling firm:
Delta Med SpA
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled June 22, 2021

Limar Hand Sanitizer, Isopropyl Alcohol 70%, Cont. 4 oz bottles, Manufactured in Dominican Republic: by Ardil Comercial S.R.L., Santo Domingo, Dominican Republic UPC 7 487040 301587

Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0691-2021
Lot/product code:
Batch Number # 079932-4611-05-J, exp. date May 2022
Recalling firm:
Ardil Comercial S.R.L.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 22, 2021

QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, Manufactured by: Guangzhou Minghui Cosmetics Co., Ltd, Baiyun District, Guanzhou, China Distributed by HoYu (US) Logistics Inc UPC 6 926645 716288

Weaker than it should be

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-0643-2021
Lot/product code:
Lot # Q20200320, exp. date 03/19/2022
Recalling firm:
HOYU(US) LOGISTICS INC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 23, 2021

TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 13G x 8.9 cm; TJM4011 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 11G x 10cm; TJC4011 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 11G x 10cm; TJM4008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 10cm; TJC4008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 10cm;

Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.

ALL 50 STATES
Full report

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

Recall #:
88314
Lot/product code:
Catalog Number//UDI: TJM6008/(01)10885403044595(17)241031(10)0001330707; TJC3513/(01)1088540344014(17)241031(10)0001330400; TJM4011/(01)10885403044588(17)241031(10)0001330949; TJC4011/(01)10885403044052(17)241031(10)0001331232; TJM4008/(01)10885403044564(10)0001331230(17)241031; TJC4008/(01)10885403044038(17)241130(10)0001334951;  Serial Numbers: 0001330707; 0001330400; 0001330400; 0001330400; 0001331232; 0001331230; 0001334951;
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 23, 2021

EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm

Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.

ALL 50 STATES
Full report

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

Recall #:
88314
Lot/product code:
Catalog Number/UDI: EJM4011/ (01)10885403464157(17)241031(10)0001330769; Serial Numbers: 0001330769; 0001331231;
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 23, 2021

TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 15G x 79mm

Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.

ALL 50 STATES
Full report

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

Recall #:
88314
Lot/product code:
Catalog Number/UDI: TIN3018/(01)10885403043819(17)241031(10)0001330956; TIN3015/(01)10885403043796(17)241031(10)0001331229;  Serial Numbers: 0001330956; 0001331229;
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 24, 2021

CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.

There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contaminated water potentially aerosolized into the operating room during surgery which could result in patient infection.

ALL 50 STATES
Full report

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

Recall #:
88621
Lot/product code:
All Serial Numbers
Recalling firm:
CardioQuip, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 25, 2021

KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005

Product label intended for the European community was distributed to the USA market via their US distribution organization

ALL 50 STATES
Full report

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

Recall #:
88427
Lot/product code:
Lot Number: KJ2858 Shelf Life (Expiration Date): 22 April 2023 Unique Device Identifier (UDI): +H66842200051/$$3230422KJ2858U
Recalling firm:
Straumann USA LLC
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 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 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 130-32-XX, Acumatch GXL 0 Degree Liner, 32mm; and Novation GXL Liner, Neutral, 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: 10885862022097, 10885862022103, 10885862022110, 10885862022127, 10885862207074, 10885862022165, 10885862022172, 10885862022189, 10885862022196
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 132-40-XX, Novation GXL Liner, Lipped Ant, 40mm; Novation GXL Liner, Lipped, 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: 10885862207043, 10885862207050, 10885862207067, 10885862303349, 10885862303462, 10885862303363
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 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 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 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 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 136-36-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 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 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 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)