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Medical Device
FDA DevicesClass II

Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1; drills, burrs,...

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Jul 1, 2026SURGIFY MEDICAL OY
Medical Device
FDA DevicesClass II

Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL He...

Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.

Jul 1, 2026Acumed LLC
Pharmaceutical
FDA DrugsClass II

Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: ...

CGMP Deviations

Jul 1, 2026Amgen, Inc.
Pharmaceutical
FDA DrugsClass II

Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: ...

CGMP Deviations

Jul 1, 2026Amgen, Inc.
Safety Alert
RSS FeedGeneral Alert

Eunha Fisheries Co., LTD. Issues Allergy Alert on Undeclared Wheat, Soy, and Sesame in Certain Frozen Olive Flounder Sashimi Products

Jul 1, 2026
Medical Device
FDA DevicesClass II

VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001

Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition.

Jul 1, 2026Ventec Life Systems, Inc.
Food & Beverage
FDA FoodClass I

6/11oz No Salt Sunflower Seeds

The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.

Jul 1, 2026George J Howe Company, Inc.
Food & Beverage
FDA FoodClass I

2.0 oz Dirty Maui Onion Chip, Plastic Bag.

Potential presence of Salmonella.

Jul 1, 2026Utz Quality Foods, LLC
Food & Beverage
FDA FoodClass I

Spring & Mulberry Mulberry Fennel Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g...

Potential Salmonella contamination.

Jul 1, 2026Spring & Mulberry Inc.
Food & Beverage
FDA FoodClass II

Joy Mango-Pina-Strawberry Lassi 16 oz.

Product not adequately pasteurized

Jul 1, 2026Joy Gourmet Foods LLC.
Food & Beverage
FDA FoodClass II

Joy Mint Lassi 16 oz.

Product not adequately pasteurized

Jul 1, 2026Joy Gourmet Foods LLC.
Food & Beverage
FDA FoodClass II

boichik bagels Whitefish Salad Ingredients: Smoked whitefish, mayonnaise (soybe...

Ingredient statement declares eggs, but eggs are omitted from the "contains" allergen statement on the product labels.

Jul 1, 2026Boichik Bagels, Inc.
Food & Beverage
FDA FoodClass II

Joy Sweet Lassi 16 oz.

Product not adequately pasteurized

Jul 1, 2026Joy Gourmet Foods LLC.
terres de moulin madame - farine de blé dur fine et complète
RappelConsovolontaire (san...

terres de moulin madame - farine de blé dur fine et complète

taux de t-2 toxine et ht-2 toxine supérieures à la valeur réglementaire

Jul 1, 2026terres de moulin madame
Food & Beverage
FDA FoodClass II

Joy Masala Chaash Lassi 16 oz., 64 oz.

Product not adequately pasteurized

Jul 1, 2026Joy Gourmet Foods LLC.
Medical Device
FDA DevicesClass II

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ...

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Jul 1, 2026Medline Industries, LP
Food & Beverage
FDA FoodClass I

2.5oz , 8oz , Zapp's Brand Bayou Blackened Ranch Potato Chips, Plastic Bag.

Potential presence of Salmonella.

Jul 1, 2026Utz Quality Foods, LLC
Food & Beverage
FDA FoodClass II

Joy Salty Lassi 16 oz.

Product not adequately pasteurized

Jul 1, 2026Joy Gourmet Foods LLC.
Food & Beverage
FDA FoodClass I

1) Spring & Mulberry Pure Dark Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), ...

Potential Salmonella contamination

Jul 1, 2026Spring & Mulberry Inc.
Food & Beverage
FDA FoodClass I

2.0 oz Dirty Sour Cream and Onion Potato Chips, Plastic Bag.

Potential presence of Salmonella.

Jul 1, 2026Utz Quality Foods, LLC
Food & Beverage
FDA FoodClass I

Spring & Mulberry Pecan Date Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), in...

Potential Salmonella contamination.

Jul 1, 2026Spring & Mulberry Inc.
Medical Device
FDA DevicesClass II

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ...

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Jul 1, 2026Medline Industries, LP
Food & Beverage
FDA FoodClass II

Motor City Pizza Co. 5 Cheese Bread Single retail pack; 22.43 oz. (1 lb. 6.4 oz....

potential salmonella contamination

Jul 1, 2026Champion Foods, LLC
Pharmaceutical
FDA DrugsClass III

hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx on...

Presence of foreign substance

Jul 1, 2026ANI Pharmaceuticals, Inc.
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