federal law violation Recalls

305 recalls tagged with “federal law violation”.

Health & Personal Care
HIGH
FDA DEVICE

Abbott i-STAT CG8+ Cartridge Recall 2025: 8,962,450 Units

Abbott Point Of Care recalled 8,962,450 i-STAT CG8+ cartridges sold nationwide in the United States. The recall stems from a lack of FDA 510(k) premarket clearance for updated sample types and measurement ranges. Healthcare providers and patients should stop using these cartridges and follow Abbott's recall instructions.

Abbott Point Of Care
Lack of
Read more
Health & Personal Care
HIGH
FDA DEVICE

Frontier Devices 301.916S1 16 mm Distraction Pin Recall Expanded (2025)

Frontier Devices and Folsom Metal Products issued a high-risk recall for 490 units of the 16 mm Distraction Pin, REF 301.916S1, distributed nationwide in the United States. The labeling includes shelf life that has not been validated. Patients and healthcare providers should stop using the device immediately and follow recall instructions.

Frontier Devices
Labeling includes
Read more
Food & Beverages
HIGH
FDA FOOD

Itacate Foods CAMPSITE LENTEJAS Lentil Soup Recalled for Undeclared Yellow Dyes (154 Packages, 2025)

Itacate Foods recalled 154 packages of CAMPSITE LENTEJAS lentil soup sold in the United States after undeclared Yellow #5 and Yellow #6 were detected on the label. The issue involves undisclosed food color additives that could trigger allergic reactions in sensitive individuals. Consumers should discard the product and contact Itacate Foods for a refund or replacement.

Itacate Foods
Undeclared Yellow
Read more
Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Pacemaker Recall 2025 Affects ACCOLADE, ALTRUA 2 and CRT-P Devices Worldwide

Boston Scientific recalled 4,841 pacemakers worldwide on 2025-08-20 after a software issue could prevent Safety Mode activation in ambulatory settings. The affected devices include ACCOLADE family pacemakers and VISIONIST and VALITUDE CRT-Ps. Patients and healthcare providers should stop using the device immediately and follow the recall instructions in the notification letter.

Boston Scientific
Software to
Read more
Health & Personal Care
HIGH
FDA DRUG

Lannett 10mg Dextroamphetamine Tablets Recalled for Foreign Tablet Contamination (2025)

Lannett Company Inc. recalls 4,848 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets. A bottle labeled 10 mg 100-count contained a 5 mg tablet. Two bottles were affected. Consumers and healthcare providers should stop using this product immediately. Contact Lannett or a healthcare provider for guidance.

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Presence of
Read more
Food & Beverages
HIGH
FDA FOOD

Great American Seafood Imports Co. Frozen Raw Shrimp Recall Covers 11,081 Cases (2025)

Great American Seafood Imports Co. recalled 11,081 cases of frozen raw shrimp sold under multiple brands. The recall cites insanitary production conditions that may have allowed Cesium-137 contamination. Consumers who purchased the 2-pound bags should not eat the product and should contact the company for refunds or replacements via email.

Great American Seafood Imports Co.
Product manufactured
Read more
Health & Personal Care
HIGH
FDA DRUG

B. Braun Lactated Ringers Injection 46,032 Containers Recalled Over Particulate Matter

B. Braun Medical recalled 46,032 containers of Lactated Ringers Injection USP sold nationwide in the United States. The recall cites the presence of particulate matter in the 1000 mL IV solution. Consumers should stop using the product immediately and contact their healthcare provider or B. Braun for guidance.

B Braun Medical
Presence of
Read more
Food & Beverages
HIGH
FDA FOOD

Tampa Maid Foods Frozen Shrimp Recalled for Cs-137 Contamination (2025)

Tampa Maid Foods recalled 776 cases of Panko Style Breaded Butterfly Shrimp due to potential Cesium-137 contamination. The product was distributed to 16 states. Consumers should not eat the shrimp and should contact the company for refunds or replacements.

TAMPA MAID FOODS
Product may
Read more
Food & Beverages
HIGH
FDA FOOD

ADMIRAL OF THE FLEET, PORTICO SEAFOOD CLASSIC Breaded Shrimp Recalled Over Cs-137 Contamination (120

ADMIRAL OF THE FLEET and PORTICO SEAFOOD CLASSIC Cleantail Breaded Butterfly Shrimp is recalled by TAMPA MAID FOODS, LLC after the FDA identified Cesium-137 contamination. The recall covers 1,200 cases distributed to multiple states. Consumers should not consume the product and should contact TAMPA MAID FOODS for refund or replacement.

ADMIRAL OF THE FLEET
Product may
Read more
Food & Beverages
HIGH
FDA FOOD

Anderson Candy Company Recalls 960,000 Peanut Rounds for Undeclared Soy Allergen (2025)

Anderson Candy Company recalled 960,000 Peanut rounds after undeclared soy allergen was found. The sizes are 2.25 oz and 3 oz. The affected distribution covers Oklahoma, Louisiana, Texas, Arkansas, Kansas, Missouri, Arizona, Alabama, Mississippi and Tennessee. Consumers should not eat the product and should contact the company for refund or replacement.

Anderson Candy Company
Undeclared soy
Read more
Health & Personal Care
HIGH
FDA DEVICE

Exactech Equinoxe Recalled 11,542 HumeraL Liners Worldwide Over Dimension Mismatch (2025)

Exactech recalled 11,542 Equinoxe reverse shoulder humeral liners worldwide after finding the articular surface position outside labeling specifications. The recall covers several REF numbers and UDIs and is active as of 2025. Healthcare providers were advised to stop using affected liners and follow manufacturer instructions.

Exactech
Reverse Shoulder
Read more
Recalled Firefly Safe & Green 32 oz. fuel bottles
HIGH
CPSC

Firefly Safe & Green 32 oz. Fuel Bottles Recalled for Poisoning Risk to Children

Firefly Fuel Inc. recalled Firefly Safe & Green 32 oz. bottles. The recall date is August 14, 2025. The fuel is sold in a clear bottle with a white cap and nozzle applicator. The product label shows Firefly brand, Safe & Green in green font, and claims Non-Toxic and Kosher. The nozzle applicator lacks child-resistant features, violating the Poison Prevention Packaging Act and the Federal Hazardous

Firefly Fuel
The recalled
Read more
Health & Personal Care
HIGH
FDA DEVICE

Penner Patient Care Penner Pacific Bathing Spa Recalled for Missing UDI (158 Units)

Penner Patient Care recalled 158 Penner Pacific Bathing Spa devices distributed nationwide in the United States. The device does not bear a unique device identifier. Healthcare providers and patients should stop using the device immediately and follow the recall instructions mailed to affected parties.

Penner Patient Care
The device
Read more
Health & Personal Care
HIGH
FDA DEVICE

Penner Patient Care Recalls 26 Penner Pacific Bathing Spa Units for Missing UDI Label (2026)

Penner Patient Care recalled 26 Penner Pacific Bathing Spa units distributed nationwide in the United States after finding they do not bear a unique device identifier. The absence of a UDI prevents reliable traceability of the devices. Healthcare providers and patients should stop using the devices and follow the manufacturer’s recall instructions.

Penner Patient Care
The device
Read more