fda regulated Recalls

689 recalls tagged with “fda regulated”.

Food & Beverages
HIGH
FDA FOOD

Harris Teeter Texas Toast Recalled Due to Undeclared Milk

Harris Teeter recalled 295 units of Asiago Texas Toast on September 11, 2025. The recall stems from undeclared milk allergens not listed on the packaging. Consumers should avoid the product and seek a refund or replacement.

Harris Teeter
Undeclared Milk.
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Bronchoscope Over Safety Instructions Clarification

Olympus Corporation recalled 619 bronchoscope units on September 11, 2025. The recall affects the EVIS EXERA b BRONCHOVIDEOSCOPE BF-XT190 due to additional instructions for safe use. Healthcare providers and patients must stop using the device immediately.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

CareFusion 303 Recalls Infusion Pump Sets Due to Performance Issues

CareFusion 303 recalled Alaris Pump Infusion Sets on September 11, 2025, after identifying performance issues. The recall affects multiple model numbers due to potential inaccuracies in flow rate and alarm settings. Healthcare providers must stop using these devices immediately and follow recall instructions.

CareFusion 303
Infusion pump
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Food & Beverages
HIGH
FDA FOOD

Gina Marie Bakery Recalls Cookies Over Undeclared Color Additives

Gina Marie Bakery recalled 172 cases of Vanilla Cookies with Raspberry Peach Jam due to undeclared Red 3 and Blue 1. The recall was initiated on September 10, 2025, after notification to the FDA. Consumers should not consume the product and seek refunds.

Gina Marie Bakery
Undeclared Red
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Food & Beverages
HIGH
FDA FOOD

Gina Marie Bakery Biscotti Recalled for Undeclared Red 40

Gina Marie Bakery recalled 172 cases of Toasted Almond & Cherry Biscotti on September 10, 2025. The recall stems from an undeclared allergen, Red 40. Consumers should not eat the product and seek refunds.

Gina Marie Bakery
Undeclared Red
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Food & Beverages
HIGH
FDA FOOD

Gina Marie Bakery Recalls Cookies Over Undeclared Dyes

Gina Marie Bakery recalled 172 cases of Vanilla with Apricot Jam Cookies on September 10, 2025. The recall follows the discovery of undeclared Red 40 and Yellow 6 in the product. Consumers should not eat these cookies and seek refunds.

Gina Marie Bakery
Undeclared Red
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Food & Beverages
HIGH
FDA FOOD

Gina Marie Bakery Recalls Biscotti Due to Undeclared Red 40

Gina Marie Bakery recalled 172 cases of Toasted Cherry Biscotti on September 10, 2025. The product contains undeclared Red 40, posing a potential health risk. Consumers should not consume the product and are advised to seek a refund or replacement.

Gina Marie Bakery
Contains undeclared
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Food & Beverages
HIGH
FDA FOOD

Goot Essa Cheese Recalled Due to Listeria Contamination

Goot Essa recalled 62 pounds of Der Mutterschaf Cheese on September 10, 2025. A positive Listeria Monocytogenes test prompted the recall. The affected cheese was distributed in Connecticut, New Jersey, Montana, and Virginia.

GOOT ESSA
The firm
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Health & Personal Care
HIGH
FDA DEVICE

Biomet Recalls Juggerknot Mini Soft Anchors Due to Labeling Error

Biomet recalled 40 units of Juggerknot Mini Soft Anchors on September 9, 2025. The recall stems from a labeling error where the carton contains 1.4mm Short devices instead of the labeled 1.0mm Mini products. Patients and healthcare providers must stop using these devices immediately.

Biomet
The outer
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Food & Beverages
HIGH
FDA FOOD

Whole Foods Market Granola Recalled Due to Allergen Risk

Whole Foods Market recalled Blueberry Almond Granola on September 9, 2025. The product contains undeclared allergens including wheat, sesame, and cashew. Six units, packaged in one-pound containers, were sold at one store in Philadelphia, PA.

WFM Purchasing, LP
Product was
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Food & Beverages
HIGH
FDA FOOD

Hale Recalls Roasted Garlic Infused Olive Oil Due to Contamination Risk

Hale recalled 54 bottles of Roasted Garlic Infused Olive Oil on September 9, 2025. The product may be contaminated with Clostridium botulinum and was manufactured without an approved process. Consumers should stop using the product immediately and seek a refund or replacement.

Hale
Potential to
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Health & Personal Care
HIGH
FDA DEVICE

BioPro Recalls Endo Heads Due to Sterility Risk

BioPro recalled 147 units of Endo Heads on September 9, 2025. A packaging issue may compromise the sterile barrier, leading to infection risk. Healthcare providers and patients should stop using the devices immediately.

BioPro
Potential packaging
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Food & Beverages
HIGH
FDA FOOD

Lee K of NY Recalls Kimchi Mackerel Over Undeclared Allergens

Lee K of NY Inc. recalled 43 units of Aged Kimchi Mackerel on September 8, 2025. The product contains undeclared milk and shrimp, posing a serious allergy risk. Consumers in New York and New Jersey should stop using the product immediately.

Lee K of NY
Product contains
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Food & Beverages
HIGH
FDA FOOD

Chetak New York Recalls Frozen Tindora Over Salmonella Risk

Chetak New York recalled over 3.5 million bags of frozen Tindora on September 5, 2025. The recall follows positive tests for Salmonella, a bacteria that can cause serious illness. Consumers should not consume the product and seek a refund or replacement immediately.

CHETAK NEW YORK
Product tested
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Food & Beverages
HIGH
FDA FOOD

Chetak New York Recalls Frozen Vegetables Due to Salmonella Risk

Chetak New York LLC recalled over 3.5 million bags of frozen mixed vegetables on September 5, 2025, due to Salmonella contamination. Consumers should not eat the product and should seek refunds or replacements. The recall affects products distributed across the United States.

CHETAK NEW YORK
Product tested
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Health & Personal Care
HIGH
FDA DEVICE

Philips Ultrasound L17-5 Transducer Recalled for Useful-Life Labeling (2025)

Two Philips Ultrasound L17-5 transducers distributed nationwide to hospitals are recalled. The recall targets labeling that defines the devices' useful life. Stop using the transducers and follow Philips Ultrasound's instructions. Hospitals should contact Philips Ultrasound for guidance.

Philips Ultrasound
To provide
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Health & Personal Care
HIGH
FDA DEVICE

Philips Ultrasound C9-4 Transducer Recalled for Lifespan Labelling — 1 Unit (2025)

Philips Ultrasound recalled 1 unit of the C9-4 Ultrasound Transducer, Model No. 989605365021, distributed nationwide in the United States. The recall focuses on clarifying and labeling the device’s useful life. Healthcare providers and patients should stop using the device immediately and follow Philips’ instructions for replacement or further steps.

Philips Ultrasound
To provide
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Food & Beverages
HIGH
FDA FOOD

Chetak New York Recalls Frozen Tuvar Lilva Due to Salmonella

Chetak New York recalled over 3.5 million bags of frozen Tuvar Lilva on September 5, 2025. The product tested positive for Salmonella, posing a significant health risk. Consumers should not consume this product and seek a refund or replacement immediately.

CHETAK NEW YORK
Product tested
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Food & Beverages
HIGH
FDA FOOD

Chetak New York Recalls Hot Green Chillies Over Salmonella Risk

Chetak New York recalled over 3.5 million bags of PREMIUM Select Hot Green Chillies on September 5, 2025. The product tested positive for Salmonella, a bacteria that can cause serious illness. Consumers should not eat the product and should seek a refund or replacement immediately.

CHETAK NEW YORK
Product tested
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