Vereinigte Staaten Recalls

Verbraucherrückrufe von FDA, CPSC, NHTSA und USDA FSIS.

Showing 24 of 17,563 results
Medical DeviceUSFDA Devices

Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.

Abiomed, Inc.
FDA DevicesClass II

Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.

Device packaged in incorrect outer box carton.

Jan 14, 2026Abiomed, Inc.
Medical DeviceUSFDA Devices

Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08

AVID Medical, Inc.
FDA DevicesClass I

Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08

Devices are not suitable for organ transplant.

Jan 14, 2026AVID Medical, Inc.
Food & BeverageUSFDA Food

Locatelli Grated Pecorino Romano, 5 and 10-pound plastic bags (units)

Ambriola Co., Inc., The
FDA FoodClass I

Locatelli Grated Pecorino Romano, 5 and 10-pound plastic bags (units)

Product tested positive for Listeria Monocytogenes.

Jan 14, 2026Ambriola Co., Inc., The
Medical DeviceUSFDA Devices

Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.

Integra LifeSciences Corp. (NeuroSciences)
FDA DevicesClass II

Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.

Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.

Jan 14, 2026Integra LifeSciences Corp. (NeuroSciences)
Food & BeverageUSFDA Food

Ore-Ida Tater Tots shaped potatoes, item number OIF00215A. Frozen potato product is packaged in clear unlabeled poly bag per case. Net wt. 30 lbs. UPC 1 00 72714 00215 8. McCain Foodservice Solutions.

McCain Foods USA Inc
FDA FoodClass II

Ore-Ida Tater Tots shaped potatoes, item number OIF00215A. Frozen potato product is packaged in clear unlabeled poly bag per case. Net wt. 30 lbs. UPC 1 00 72714 00215 8. McCain Foodservice Solutions.

Clear hard plastic fragments.

Jan 14, 2026McCain Foods USA Inc
Food & BeverageUSFDA Food

Sam Dry Fruits & Nuts PISTACHIO Meats Whole LOT #: PK00459 NET WEIGHT: 30 LBS PACK DATE: AUGUST/2025 EXPIRATION DATE: AUGUST/2027

Sam Dry Fruits and Nuts Enterprises, Inc
FDA FoodClass I

Sam Dry Fruits & Nuts PISTACHIO Meats Whole LOT #: PK00459 NET WEIGHT: 30 LBS PACK DATE: AUGUST/2025 EXPIRATION DATE: AUGUST/2027

Potential contamination with Salmonella.

Jan 14, 2026Sam Dry Fruits and Nuts Enterprises, Inc
PharmaceuticalUSFDA Drugs

ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4006-9, UPC 787647101887

Medinatura New Mexico, inc.
FDA DrugsClass I

ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4006-9, UPC 787647101887

Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.

Jan 14, 2026Medinatura New Mexico, inc.
Food & BeverageUSFDA Food

EverRoast Chicken Caesar Wrap 85004224455 Net Wt: 11.25 oz (303g)

GBC Food Services, LLC
FDA FoodClass I

EverRoast Chicken Caesar Wrap 85004224455 Net Wt: 11.25 oz (303g)

Potential presence of Listeria monocytogenes.

Jan 14, 2026GBC Food Services, LLC
Food & BeverageUSFDA Food

Baraka Gourmet Pastry Kunafe 6.7oz., UPC 822514291060, 18 retail units per wholesale case

ZIYAD BROTHERS IMPORTING
FDA FoodClass II

Baraka Gourmet Pastry Kunafe 6.7oz., UPC 822514291060, 18 retail units per wholesale case

May contain partially hydrogenated oils

Jan 14, 2026ZIYAD BROTHERS IMPORTING
Food & BeverageUSFDA Food

Snack Crackers 100to en boca (ciento en boca) Rovira, Net Wt. 1.5 oz, 12 pack Snack Crackers to go, 12 packets (Net Wt 1.5 oz bag) per box, 12/ 1.5 oz packets box, 6 box per case. UPC 072981023064 100to en boca (ciento en boca), Rovira, Net Wt. 7 oz, 7 pack Snack Crackers to go, 7 packets (Net Wt 1 oz bag) per box, 18/7oz box per case. UPC 072981003035 100to en boca (ciento en boca) Rovira, tray, Net Wt. 18 oz, 6 packets (Net Wt 1.5 oz tray) per box per case. UPC 072981003073

Rovira Biscuit Corporation
FDA FoodClass II

Snack Crackers 100to en boca (ciento en boca) Rovira, Net Wt. 1.5 oz, 12 pack Snack Crackers to go, 12 packets (Net Wt 1.5 oz bag) per box, 12/ 1.5 oz packets box, 6 box per case. UPC 072981023064 100to en boca (ciento en boca), Rovira, Net Wt. 7 oz, 7 pack Snack Crackers to go, 7 packets (Net Wt 1 oz bag) per box, 18/7oz box per case. UPC 072981003035 100to en boca (ciento en boca) Rovira, tray, Net Wt. 18 oz, 6 packets (Net Wt 1.5 oz tray) per box per case. UPC 072981003073

Undeclared colors FD&C Yellow #6, and FD&C Red 40

Jan 14, 2026Rovira Biscuit Corporation
Food & BeverageUSFDA Food

Locatelli Grated Pecorino Romano 4 oz and 8 oz plastic cup & lid, 12 units per case

Ambriola Co., Inc., The
FDA FoodClass I

Locatelli Grated Pecorino Romano 4 oz and 8 oz plastic cup & lid, 12 units per case

Product tested positive for Listeria Monocytogenes.

Jan 14, 2026Ambriola Co., Inc., The
Food & BeverageUSFDA Food

Boar's Head Grated Pecorino Romano, 6 oz Plastic Cup & Lid, 12 units per case

Ambriola Co., Inc., The
FDA FoodClass I

Boar's Head Grated Pecorino Romano, 6 oz Plastic Cup & Lid, 12 units per case

Product tested positive for Listeria Monocytogenes.

Jan 14, 2026Ambriola Co., Inc., The
PharmaceuticalUSFDA Drugs

ReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4005-9, UPC 787647101863

Medinatura New Mexico, inc.
FDA DrugsClass I

ReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4005-9, UPC 787647101863

Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.

Jan 14, 2026Medinatura New Mexico, inc.
Food & BeverageUSFDA Food

Vanilla Econo, Galletas de Vainilla, 8 paquets per Net Wt. 9.6 oz box (272 g), 6 box per case. UPC 072981005022

Rovira Biscuit Corporation
FDA FoodClass II

Vanilla Econo, Galletas de Vainilla, 8 paquets per Net Wt. 9.6 oz box (272 g), 6 box per case. UPC 072981005022

Undeclared colors FD&C Yellow #6, and FD&C Red 40

Jan 14, 2026Rovira Biscuit Corporation
Food & BeverageUSFDA Food

Spicy Egg Potatoes Cheese Tacos, Fresh to You brand, Ready to Eat, Refrigerated. Net wt. 6.3oz. UPC 100000010389, LPK110369V06. Fresh & Ready Foods, 701 Monster Rd, Renton, WA 98057.

Fresh & Ready Foods LLC
FDA FoodClass II

Spicy Egg Potatoes Cheese Tacos, Fresh to You brand, Ready to Eat, Refrigerated. Net wt. 6.3oz. UPC 100000010389, LPK110369V06. Fresh & Ready Foods, 701 Monster Rd, Renton, WA 98057.

Foreign material.

Jan 14, 2026Fresh & Ready Foods LLC
Food & BeverageUSFDA Food

Locatelli Grated Pecorino Romano 48/8oz Shipper, Plastic Cup & Lid, 48 units per case

Ambriola Co., Inc., The
FDA FoodClass I

Locatelli Grated Pecorino Romano 48/8oz Shipper, Plastic Cup & Lid, 48 units per case

Product tested positive for Listeria Monocytogenes.

Jan 14, 2026Ambriola Co., Inc., The
PharmaceuticalUSFDA Drugs

Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852. NDC 71384-746-06.

Imprimis NJOF, LLC
FDA DrugsClass II

Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852. NDC 71384-746-06.

Presence of particulate matter - Glass like particles.

Jan 14, 2026Imprimis NJOF, LLC
Medical DeviceUSFDA Devices

Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Version: Not Applicable Product Description: The HFD100 Head Fixation Device provides rigid skeletal fixation within the optimal imaging envelope while introducing minimal artifacts in the acquired images. There are two different assemblies for the HFD100. The standard HFD100 is equipped with a table adapter for use with either the operating room table or the angiography table. For sites with a Hill-Rom TruSystem 7500 Hybrid Neuro MR Operating Table (ORT400), the HFD100 has a split block clamp assembly (Trumpf Mount Clamp Assembly) which connects directly to the table back section. The HFD100 system is also comprised of the linkage components to mount the skull clamp to the table adapter, and the 3-pin skull clamp. The linkage system is used to position the skull clamp in the necessary position, without colliding with the magnet bore. Component: Not a component.

IMRIS Imaging Inc
FDA DevicesClass II

Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Version: Not Applicable Product Description: The HFD100 Head Fixation Device provides rigid skeletal fixation within the optimal imaging envelope while introducing minimal artifacts in the acquired images. There are two different assemblies for the HFD100. The standard HFD100 is equipped with a table adapter for use with either the operating room table or the angiography table. For sites with a Hill-Rom TruSystem 7500 Hybrid Neuro MR Operating Table (ORT400), the HFD100 has a split block clamp assembly (Trumpf Mount Clamp Assembly) which connects directly to the table back section. The HFD100 system is also comprised of the linkage components to mount the skull clamp to the table adapter, and the 3-pin skull clamp. The linkage system is used to position the skull clamp in the necessary position, without colliding with the magnet bore. Component: Not a component.

Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury.

Jan 14, 2026IMRIS Imaging Inc
Food & BeverageUSFDA Food

Sam's Pecorino Romano grated, 1.5 lb Plastic Bags, 12 units per case

Ambriola Co., Inc., The
FDA FoodClass I

Sam's Pecorino Romano grated, 1.5 lb Plastic Bags, 12 units per case

Product tested positive for Listeria Monocytogenes.

Jan 14, 2026Ambriola Co., Inc., The
Medical DeviceUSFDA Devices

The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor

Sophysa
FDA DevicesClass II

The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor

Customer complaints of Pressio monitor rebooting.

Jan 14, 2026Sophysa
Food & BeverageUSFDA Food

Town Food Service EQ CO Inc. brand Aluminum Sauce Pans in 1QT, 1.5QT, 2 QT, and 3QT sizes; UPC Codes: 843784003559, 843784003566, 843784003573, 843784003580

Town Food Service Equip Co Inc
FDA FoodClass II

Town Food Service EQ CO Inc. brand Aluminum Sauce Pans in 1QT, 1.5QT, 2 QT, and 3QT sizes; UPC Codes: 843784003559, 843784003566, 843784003573, 843784003580

Product found to contain leachable lead levels.

Jan 14, 2026Town Food Service Equip Co Inc
PharmaceuticalUSFDA Drugs

ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA

Signature Formulations, LLC
FDA DrugsClass II

ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA

cGMP Deviations

Jan 14, 2026Signature Formulations, LLC
Food & BeverageUSFDA Food

Vanilla Treats Crackers, Rovira, Net Wt. 31 oz (878.83 g) cans, 6/31oz cans per case. Mini Vanilla Treats, Rovira, 12 to go packs (0.8oz (22.7g) each), Net Wt 9.6 oz (272g), 6/9.6oz boxes per case. UPC072981005374

Rovira Biscuit Corporation
FDA FoodClass II

Vanilla Treats Crackers, Rovira, Net Wt. 31 oz (878.83 g) cans, 6/31oz cans per case. Mini Vanilla Treats, Rovira, 12 to go packs (0.8oz (22.7g) each), Net Wt 9.6 oz (272g), 6/9.6oz boxes per case. UPC072981005374

Undeclared colors FD&C Yellow #6, and FD&C Red 40

Jan 14, 2026Rovira Biscuit Corporation
PharmaceuticalUSFDA Drugs

ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA

Signature Formulations, LLC
FDA DrugsClass II

ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA

cGMP Deviations

Jan 14, 2026Signature Formulations, LLC

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