États-Unis Recalls

Tops GOLD Mixed Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288611380 INGREDIENTS:Mustard Oil Tops GOLD Mixed Pickle NET QTY.: 158.73oz PRODUCT OF INDIA UPC: 8904288612950 INGREDIENTS:Mustard Oil

Mangalm LLC

Tops GOLD Mixed Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288611380 INGREDIENTS:Mustard Oil Tops GOLD Mixed Pickle NET QTY.: 158.73oz PRODUCT OF INDIA UPC: 8904288612950 INGREDIENTS:Mustard Oil

Potential adulteration with erucic acid from mustard oil ingredient.

Apr 1, 2026Mangalm LLC

Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314.

Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314.

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136-5, 21136-7, 21137-4, 21137-7, 21138-4, 21139-4.

Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136-5, 21136-7, 21137-4, 21137-7, 21138-4, 21139-4.

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Merit Medical Systems, Inc.

BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H965103028051/EU, H965103028061/A, H965103028061/EU, H965103028070/A, H965103028070/EU, H965103028080/A, H965103028080/EU, H965103028090/A, H965103028090/EU, H965103028161/A, H965103028181/A, H965103028191/A, H965103028191/EU, H965103028201/A, H965103028211/A, H965103028220/A, H965103028230/A, H965103028240/A, H965103038181/A

FDA DevicesClass I

BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H965103028051/EU, H965103028061/A, H965103028061/EU, H965103028070/A, H965103028070/EU, H965103028080/A, H965103028080/EU, H965103028090/A, H965103028090/EU, H965103028161/A, H965103028181/A, H965103028191/A, H965103028191/EU, H965103028201/A, H965103028211/A, H965103028220/A, H965103028230/A, H965103028240/A, H965103038181/A

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.

Apr 1, 2026Merit Medical Systems, Inc.

Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate; Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm; Article Numbers: 21122-10, 21122-6, 21122-8. 4. Clavicle Plate, Lateral; Article Numbers: 21123-4, 21124-4, 21127-6, 21128-6.

Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate; Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm; Article Numbers: 21122-10, 21122-6, 21122-8. 4. Clavicle Plate, Lateral; Article Numbers: 21123-4, 21124-4, 21127-6, 21128-6.

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3006 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.

Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3006 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.

Koven Technology, Inc.

Apr 1, 2026Koven Technology, Inc.

Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.

Product labeling includes a fetal indication for use that is not cleared under its 510(k).

Philips Respironics, Inc.

Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.

FDA DevicesClass I

Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

Apr 1, 2026Philips Respironics, Inc.

Merit Medical Systems, Inc.

DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H787103028051/A, H787103028055/A, H787103028061/A, H787103028075/A, H787103028085/A, H787103028095/A, H787103028165/A, H787103028181/A, H787103028185/A, H787103028191/A, H787103028195/A, H787103028205/A, H787103028215/A, H787103028225/A, H787103028235/A

FDA DevicesClass I

DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H787103028051/A, H787103028055/A, H787103028061/A, H787103028075/A, H787103028085/A, H787103028095/A, H787103028165/A, H787103028181/A, H787103028185/A, H787103028191/A, H787103028195/A, H787103028205/A, H787103028215/A, H787103028225/A, H787103028235/A

Apr 1, 2026Merit Medical Systems, Inc.

Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;

Straumann USA LLC

Apr 1, 2026Straumann USA LLC

Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;

A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.

Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System

Orthalign, Inc

Apr 1, 2026Orthalign, Inc

Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System

Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)

Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.

Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.

MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

Beckman Coulter, Inc.

Apr 1, 2026Beckman Coulter, Inc.

MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

Due to the likely presence of contamination in well(s).

Apr 1, 2026Philips Ultrasound, Inc

Philips L12-5 Ultrasound Transducer

Philips Ultrasound, Inc

FDA DevicesClass III

Philips L12-5 Ultrasound Transducer

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Distribuidora de Alimentos Sendero LLC

Gorditas de Azucar UPC 860010238134

FDA FoodClass I

Gorditas de Azucar UPC 860010238134

Gorditas and Doraditas are missing the following allergens in product label: Wheat and Soy

Apr 1, 2026Distribuidora de Alimentos Sendero LLC

Ajinomoto Foods North America Inc.

Item 5654390 Ajinomoto Golden Tiger Vegetable Fried Rice - Long grain white rice and crispy vegetables in a savory sauce. Net wt. 3lbs per bag. Retail bag UPC 076366565439. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 4/3lb. bags or 12 lbs. per case. Case UPC 10076366565436. All products are intended to be stored frozen and fully cooked to 165F before eating.

Apr 1, 2026Ajinomoto Foods North America Inc.

Item 5654390 Ajinomoto Golden Tiger Vegetable Fried Rice - Long grain white rice and crispy vegetables in a savory sauce. Net wt. 3lbs per bag. Retail bag UPC 076366565439. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 4/3lb. bags or 12 lbs. per case. Case UPC 10076366565436. All products are intended to be stored frozen and fully cooked to 165F before eating.

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.

FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Savannah Bee Company Inc.

SAVANNAH BEE COMPANY HONEY BBQ SAUCE MUSTARD NET 16 FL OZ (453g), PACKED IN BOTTLES. INGREDIENTS: MUSTARD (DISTILLED VINEGAR, WATER, MUSTARD SEED, SALT, SPICES (INCLUDING PAPRIKA AND TUMERIC), NATURAL FLAVOR, GARLIC), HONEY, WATER, DISTILLED VINEGAR, SUGAR, TOMATO CONCENTRATE, HABANERO PEPPERS, GARLIC, SPICES, SALT, ONION, POTASSIUM SORBATE, SODIUM BENZOATE, NATURAL FLAVOR UPC 8 50033 93758 9 BOTTLED BY: BOBBEES FOR SAVANNAH BEE COMPANY 211 JONNY MERCER BLVD, SAVANNAH, GA 31410

Apr 1, 2026Savannah Bee Company Inc.

SAVANNAH BEE COMPANY HONEY BBQ SAUCE MUSTARD NET 16 FL OZ (453g), PACKED IN BOTTLES. INGREDIENTS: MUSTARD (DISTILLED VINEGAR, WATER, MUSTARD SEED, SALT, SPICES (INCLUDING PAPRIKA AND TUMERIC), NATURAL FLAVOR, GARLIC), HONEY, WATER, DISTILLED VINEGAR, SUGAR, TOMATO CONCENTRATE, HABANERO PEPPERS, GARLIC, SPICES, SALT, ONION, POTASSIUM SORBATE, SODIUM BENZOATE, NATURAL FLAVOR UPC 8 50033 93758 9 BOTTLED BY: BOBBEES FOR SAVANNAH BEE COMPANY 211 JONNY MERCER BLVD, SAVANNAH, GA 31410

Undeclared Allergens: Soy & Wheat. The firm was notified by a customer that the product is labeled as Savannah Bee Company Honey BBQ Sauce "Mustard", but the product inside the bottle is a different flavor of BBQ sauce. After investigation, the firm determined that the product in the bottle is their Honey BBQ Sauce "Sweet". The BBQ sauce "Sweet" contains wheat and soy which is not listed on the BBQ Sauce "Mustard" label.

Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.

Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.

Ajinomoto Foods North America Inc.

Item 5650173 Trader Joe's Japanese Style Fried Rice with Edamame, Tofu, and Hijiki Seaweed. SKU #097908. Net wt. 1lb. per bag. Retail bag UPC 00979085. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 24/1lb. bags per case. Case UPC 10097908500001. All products are intended to be stored frozen and fully cooked to 165F before eating.

Apr 1, 2026Ajinomoto Foods North America Inc.

Item 5650173 Trader Joe's Japanese Style Fried Rice with Edamame, Tofu, and Hijiki Seaweed. SKU #097908. Net wt. 1lb. per bag. Retail bag UPC 00979085. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 24/1lb. bags per case. Case UPC 10097908500001. All products are intended to be stored frozen and fully cooked to 165F before eating.

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.

Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Ajinomoto Foods North America Inc.

Item 5650883 Ajinomoto Teppanyaki Style Vegetable Fried Rice - Japanese-style fried rice made with colorful vegetables in an aromatic garlic butter sauce. There are 6/9oz. bags per box or 54oz per box. Retail box UPC 071757508835. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 8/54oz boxes or 27lb. per case. Case UPC 10071757508832. All products are intended to be stored frozen and fully cooked to 165F before eating.

Apr 1, 2026Ajinomoto Foods North America Inc.

Item 5650883 Ajinomoto Teppanyaki Style Vegetable Fried Rice - Japanese-style fried rice made with colorful vegetables in an aromatic garlic butter sauce. There are 6/9oz. bags per box or 54oz per box. Retail box UPC 071757508835. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 8/54oz boxes or 27lb. per case. Case UPC 10071757508832. All products are intended to be stored frozen and fully cooked to 165F before eating.

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.

Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.

I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Forearm Plate, Straight; Article Numbers: 21605-11, 21605-6, 21605-9. 3. Straight Compression Plate; Article Numbers: 21105-6, 21105-8. 4. Straight Plate, 1.5mm; Article Numbers: 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, 21104-9. 5. Straight Plate, 2.0mm; Article Numbers: 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, 21101-13. 6. Straight Plate, 3.5mm; Article Number: 21102-6. 7. Straight Plate, 4.5mm; Article Numbers: 21103-8, 21103-11, 21103-10, 21103-11, 21103-12, 21103-13, 21103-8, 21103-9.

I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Forearm Plate, Straight; Article Numbers: 21605-11, 21605-6, 21605-9. 3. Straight Compression Plate; Article Numbers: 21105-6, 21105-8. 4. Straight Plate, 1.5mm; Article Numbers: 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, 21104-9. 5. Straight Plate, 2.0mm; Article Numbers: 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, 21101-13. 6. Straight Plate, 3.5mm; Article Number: 21102-6. 7. Straight Plate, 4.5mm; Article Numbers: 21103-8, 21103-11, 21103-10, 21103-11, 21103-12, 21103-13, 21103-8, 21103-9.

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).