Vereinigte Staaten Recalls

GE Healthcare Ireland Limited

GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.

Apr 15, 2026GE Healthcare Ireland Limited

GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.

Presence of particulate matter

GE Healthcare Ireland Limited

GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.

Apr 15, 2026GE Healthcare Ireland Limited

GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.

Presence of particulate matter

Apr 15, 2026Cook Incorporated

COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704.

Cook Incorporated

FDA DevicesClass II

COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704.

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV 06506, U.S.A, Made in Ireland, NDC 58151-506-91

Viatris, Inc.

Apr 15, 2026Viatris, Inc.

Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV 06506, U.S.A, Made in Ireland, NDC 58151-506-91

Failed Dissolution Specifications

Apr 15, 2026Medline Industries, LP

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: CVOR ANGIOGRAPHY PACK-LF, Medline SKU DYNJ42367B

Medline Industries, LP

FDA DevicesClass I

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: CVOR ANGIOGRAPHY PACK-LF, Medline SKU DYNJ42367B

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

Pure Vitamins and Natural Supplements, LLC

Blue Bull Extreme Male Enhancement Supplement, total of 15 pouches per box, Net Wt 15 G each pouch. Dosage: Consume Entire Pouch 30 Minutes before Intercourse. Produced by Blue Bull Corporation Made In USA. UPC Code 707443349917

FDA FoodClass I

Blue Bull Extreme Male Enhancement Supplement, total of 15 pouches per box, Net Wt 15 G each pouch. Dosage: Consume Entire Pouch 30 Minutes before Intercourse. Produced by Blue Bull Corporation Made In USA. UPC Code 707443349917

FDA analysis revealed the presence of undeclared sildenafil

Apr 15, 2026Pure Vitamins and Natural Supplements, LLC

0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case).

Fresenius Kabi USA, LLC

Apr 15, 2026Fresenius Kabi USA, LLC

0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case).

Lack of Assurance of Sterility

MEI YU CHENG DA TRADING INC

Olive Skewers individually wrapped and packaged in clear plastic bag; 500g; INGREDIENTS: Olive, edible salt, white sugar, monosodium glutamate, licorice, cloves, food additives (citric acid, DL malic acid, saccharin, sodium saccharin, steviol glycosides, aspartame, vanillin, ethyl malt powder, lemon yellow, carmine, sodium benzoate, potassium sorbate, sodium metabisulfite); MANUFACTURER: Fuzhou Hangzhengiou food Co. Ltd; UPC: 6 922279 985205

FDA FoodClass III

Olive Skewers individually wrapped and packaged in clear plastic bag; 500g; INGREDIENTS: Olive, edible salt, white sugar, monosodium glutamate, licorice, cloves, food additives (citric acid, DL malic acid, saccharin, sodium saccharin, steviol glycosides, aspartame, vanillin, ethyl malt powder, lemon yellow, carmine, sodium benzoate, potassium sorbate, sodium metabisulfite); MANUFACTURER: Fuzhou Hangzhengiou food Co. Ltd; UPC: 6 922279 985205

Products contain banned sweetener: cyclamates.

Apr 15, 2026MEI YU CHENG DA TRADING INC

MEI YU CHENG DA TRADING INC

DADI NONGFU DRIED SALT CHILLI VEGETABLE(S); Ingredients: Radish, chili, roasted sesame, prickly ash, edible salt, soybean oil, edible vinegar, white granulated sugar, spices, food additives (sodium glutamate, citric acid, sodium benzoate, potassium sorbate, sodium saccharin, acesulfame, sucralose, disodium EDTA, turmeric).; Allergen: This product contains sesame and soy products; Net Wt. 14.1 oz(400g)

FDA FoodClass III

DADI NONGFU DRIED SALT CHILLI VEGETABLE(S); Ingredients: Radish, chili, roasted sesame, prickly ash, edible salt, soybean oil, edible vinegar, white granulated sugar, spices, food additives (sodium glutamate, citric acid, sodium benzoate, potassium sorbate, sodium saccharin, acesulfame, sucralose, disodium EDTA, turmeric).; Allergen: This product contains sesame and soy products; Net Wt. 14.1 oz(400g)

Products contain banned sweetener: cyclamates.

Apr 15, 2026MEI YU CHENG DA TRADING INC

Apr 15, 2026Cook Incorporated

COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791

Cook Incorporated

FDA DevicesClass II

COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Apr 15, 2026Blueroot Health, Inc.

Vital Nutrients Aller-C (vitamin C, citrus bioflavonoids, isoquercitrin, and bromelain)100 count bottles and 200 count bottles

Blueroot Health, Inc.

FDA FoodClass II

Vital Nutrients Aller-C (vitamin C, citrus bioflavonoids, isoquercitrin, and bromelain)100 count bottles and 200 count bottles

Contains undeclared egg, soy, and hazelnut

Apr 15, 2026Zarlengo Italian Ice

Zarlengo's Chocolate Chocolate Chip Gelato packaged in multiple sizes (6 fl oz cups, 16 fl oz cups, 32 fl oz cups, 1-gallon bucket/pail and 2-gallon bucket/pail) , Net Wt. 6 fl oz cups - clear freezer grade and round Polyethylene terephthalate cup with peelable paper lid, laminated with heat-sealable plastic, 16 fl oz cups and 32 fl oz cups translucent freezer grade and round High-Density Polyethylene container with lid and 1-Gallon and 2-Gallon bucket/pail - white round food and freezer grade High-Density Polyethylene bucket/pail with tamper resistant lid.

Zarlengo Italian Ice

FDA FoodClass II

Zarlengo's Chocolate Chocolate Chip Gelato packaged in multiple sizes (6 fl oz cups, 16 fl oz cups, 32 fl oz cups, 1-gallon bucket/pail and 2-gallon bucket/pail) , Net Wt. 6 fl oz cups - clear freezer grade and round Polyethylene terephthalate cup with peelable paper lid, laminated with heat-sealable plastic, 16 fl oz cups and 32 fl oz cups translucent freezer grade and round High-Density Polyethylene container with lid and 1-Gallon and 2-Gallon bucket/pail - white round food and freezer grade High-Density Polyethylene bucket/pail with tamper resistant lid.

Soy Lecithin listed in ingredients statement, but Soy is not mentioned in the contains statement.

Apr 15, 2026Medline Industries, LP

NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline SKU 70085107; 4. SYRINGE,12ML,TR/FR,RA,W/RES, Medline SKU 70087007; 5. MTO,SYRINGE,12ML,TR/FG,RA,W/RES, Medline SKU 70087107; 6. SYRINGE,12ML,TR/FR,RA,W/O,RES,-,PKG, Medline SKU 70088007; 7. SYRINGE,10ML,PP/FR,RA,-,PKG, Medline SKU 70095007; 8. SYRINGE,10ML,PP/FG,RA,-,PKG, Medline SKU 70095107; 9. SYRINGE,12ML,W/RES,PP/FR,RA,PG, Medline SKU 70097007; 10. SYRINGE,12ML,PP/FG,RA,W/RES,-,PKG, Medline SKU 70097107; 11. SYRINGE,12ML,PP/FG,RA,W/O,RES, Medline SKU 70098107; 12. SYRINGE,20ML,TR/FR,RA,OEM,PG, Medline SKU 80075027; 13. SYRINGE,10ML,ANGIO,W/RA,-,OEM, Medline SKU 80085007; 14. SYRINGE,12ML,TR/FR,RA,OEM, Medline SKU 80087007; 15. SYRINGE,10ML,PP/FR,RA,-,OEM,-,PG, Medline SKU 80095007; 16. SYRINGE,10ML,PP/FG,RA,OEM,PG, Medline SKU 80095107; 17. SYRINGE,12ML,PP/FG,RA,-,OEM,-,PG, Medline SKU 80097107; 18. CATH SET UP PACK, Medline SKU DYNJ46711O

Medline Industries, LP

FDA DevicesClass I

NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline SKU 70085107; 4. SYRINGE,12ML,TR/FR,RA,W/RES, Medline SKU 70087007; 5. MTO,SYRINGE,12ML,TR/FG,RA,W/RES, Medline SKU 70087107; 6. SYRINGE,12ML,TR/FR,RA,W/O,RES,-,PKG, Medline SKU 70088007; 7. SYRINGE,10ML,PP/FR,RA,-,PKG, Medline SKU 70095007; 8. SYRINGE,10ML,PP/FG,RA,-,PKG, Medline SKU 70095107; 9. SYRINGE,12ML,W/RES,PP/FR,RA,PG, Medline SKU 70097007; 10. SYRINGE,12ML,PP/FG,RA,W/RES,-,PKG, Medline SKU 70097107; 11. SYRINGE,12ML,PP/FG,RA,W/O,RES, Medline SKU 70098107; 12. SYRINGE,20ML,TR/FR,RA,OEM,PG, Medline SKU 80075027; 13. SYRINGE,10ML,ANGIO,W/RA,-,OEM, Medline SKU 80085007; 14. SYRINGE,12ML,TR/FR,RA,OEM, Medline SKU 80087007; 15. SYRINGE,10ML,PP/FR,RA,-,OEM,-,PG, Medline SKU 80095007; 16. SYRINGE,10ML,PP/FG,RA,OEM,PG, Medline SKU 80095107; 17. SYRINGE,12ML,PP/FG,RA,-,OEM,-,PG, Medline SKU 80097107; 18. CATH SET UP PACK, Medline SKU DYNJ46711O

5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-456-05, Unit of Sale NDC Number: 65219-456-60.

Fresenius Kabi USA, LLC

Apr 15, 2026Fresenius Kabi USA, LLC

5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-456-05, Unit of Sale NDC Number: 65219-456-60.

Lack of Assurance of Sterility

0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by Fresenius Kabi, Unit of Sale NDC Number: 17271-701-07.

Fresenius Kabi USA, LLC

Apr 15, 2026Fresenius Kabi USA, LLC

0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by Fresenius Kabi, Unit of Sale NDC Number: 17271-701-07.

Lack of Assurance of Sterility

Ford Motor Company - Sun Visor Wiring May Cause Fire

NHTSAGeneral Alert

Ford Motor Company - Sun Visor Wiring May Cause Fire

Damaged wires can create an electrical short and cause a fire in the A-pillar area, increasing the risk of injury or a crash.

Ford Motor Company - Block Heater May Overheat and Cause Fire

NHTSAGeneral Alert

Ford Motor Company - Block Heater May Overheat and Cause Fire

An overheated engine block heater can increase the risk of a fire.

Ford Motor Company - Unexpected Downshift Can Cause Loss of Control

NHTSAPOWER TRAIN

Ford Motor Company - Unexpected Downshift Can Cause Loss of Control

Unexpectedly downshifting into second gear may result in a loss of vehicle control, increasing the risk of a crash.

Ford Motor Company - Missing Front Axle Hub Spindle Nut

NHTSAWHEELS

Ford Motor Company - Missing Front Axle Hub Spindle Nut

A missing spindle nut may lead to brake system damage or wheel detachment, resulting in a loss of vehicle control and increasing the risk of a crash.

Ford Motor Company - Loss of Drive Power due to Transmission Misalignment

NHTSAPOWER TRAIN

Ford Motor Company - Loss of Drive Power due to Transmission Misalignment

Excessive wear of the transmission and transfer case splines may result in a loss of drive power or vehicle rollaway, increasing the risk of a crash.

Harley-Davidson Motor Company

Harley-Davidson Motor Company - Loss of Rear Brakes

NHTSASERVICE BRAKES,...

Harley-Davidson Motor Company - Loss of Rear Brakes

Loss of the rear brakes increases the risk of a crash.

Apr 13, 2026Harley-Davidson Motor Company

Jayco, Inc. - Incorrect Seating Capacity on Label/FMVSS 110

Jayco, Inc.

NHTSAEQUIPMENT

Jayco, Inc. - Incorrect Seating Capacity on Label/FMVSS 110

Unbelted passengers may not be properly restrained in a crash, increasing their risk of injury.

Apr 13, 2026Jayco, Inc.

Apr 10, 2026Bentley Motors, Inc.

Bentley Motors, Inc. - Incorrect Weight Capacity on Label/FMVSS 110

Bentley Motors, Inc.

NHTSAEQUIPMENT

Bentley Motors, Inc. - Incorrect Weight Capacity on Label/FMVSS 110

Incorrect weight information may lead to unintentionally overloading the vehicle, increasing the risk of a crash.