cpsc regulated Recalls

2,056 recalls tagged with “cpsc regulated”.

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
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Health & Personal Care
HIGH
FDA DEVICE

Frontier Devices 301.914S1 Distraction Pin Recall: 10,960 Units Due to Labeling Issue

Frontier Devices recalled 10,960 units of the 301.914S1 Distraction Pin due to unvalidated shelf life labels. The recall affects medical professionals and patients who use this device risk relying on potentially inaccurate lifespan data. Users should stop using the distraction pin immediately and contact their healthcare provider or Folsom Metal Products for further instructions.

Folsom Metal Products
Labeling includes
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Food & Beverages
HIGH
FDA FOOD

Taylor Farms Retail Salad Kit Recalled for Undeclared Sesame and Soy Allergens (2025)

Taylor Farms Retail issued a Class I recall for 8,284 salad kits after undeclared sesame and soy allergens were found inside a dressing packet. The recall covers products labeled under Taylor FARMS Honey Balsamic Salad Kit sold across 19 states. Consumers should not eat the product and should seek refunds or replacements from Taylor Farms Retail.

Taylor Farms Retail
Undeclared allergens
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Health & Personal Care
HIGH
FDA DEVICE

Abbott i-STAT CG8+, EG7+, EG6+ Cartridges Recalled in 2025 Over Missing 510(k) Clearance

Abbott Point Of Care recalled 547,250 i-STAT CG8+, EG7+, and EG6+ cartridges distributed nationwide in the United States. The recall concerns lack of 510(k) premarket clearance for updated sample types and measurement ranges. Hospitals and clinicians should stop using these cartridges immediately and follow Abbott’s recall instructions.

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

Frontier Devices 301.912S1 12 mm Distraction Pin Recall Expanded to 3,790 Units (Rx Only)

Frontier Devices recalled 3,790 units of the 12 mm Distraction Pin, REF 301.912S1, distributed nationwide in the United States. The recall cites labeling that includes shelf life which has not been validated. The high-risk device category reflects potential documentation and shelf-life concerns. Healthcare providers and patients should follow recall instructions and contact the manufacturer for a回

Frontier Devices
Labeling includes
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Health & Personal Care
HIGH
FDA DEVICE

Abbott i-STAT CG4+ Cartridge Recall: 9,067,050 Units Across U.S. With 510(k) Clearance Issue (2025)

Abbott Point Of Care recalled 9,067,050 i-STAT CG4+ cartridges sold nationwide in the United States. The recall cites a lack of 510(k) premarket clearance to reflect updated sample type for lactate and measurement ranges for pH and PO2. Patients and healthcare providers should stop using the device immediately and follow manufacturer instructions.

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

Abbott Point Of Care i-STAT EG7+ Cartridges Recalled Over 6.1 Million Units in 2025

Abbott Point Of Care recalled 6,115,950 i-STAT EG7+ cartridges distributed nationwide in the United States. The recall centers on lack of 510(k) clearance for updated sample types and measurement ranges. Healthcare providers and patients should stop using the cartridges immediately and follow Abbott’s recall instructions for next steps.

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

Bard Peripheral Vascular Venclose DigiRF Generator Recall Affects 1,725 Units Worldwide

Bard Peripheral Vascular recalled 1,725 Venclose digiRF Generators with software version 3.35. The recall centers on a catheter verification feature that can produce false positives and disable compatible EVSRF catheters. The worldwide distribution includes the United States. Patients and healthcare providers should stop using the device and await further instructions from the manufacturer.

Bard Peripheral Vascular
Software version
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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
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Health & Personal Care
HIGH
FDA DEVICE

Abiomed Impella Controller AIC Recall 2025 Affects 71 Units Across 6 Regions

Abiomed’s automated Impella Controller recall covers 71 units distributed across the US and international markets. The devices may have a Pump Driver Circuit Assembly that does not meet current specifications. This can reduce pump performance or trigger a pump stop with alarms. Clinicians and patients should follow manufacturer instructions and contact Abiomed or healthcare providers for guidance.

Abiomed
Specific Automated
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Health & Personal Care
HIGH
FDA DRUG

Baxter Acetaminophen Injection 1000 mg/100 mL Recall for Discoloration

Baxter Healthcare’s Acetaminophen Injection 1000 mg/100 mL is recalled. The nationwide recall covers 13,000 containers with lot 24A27G66 and expiring 12/31/2025. The FDA lists discoloration as the hazard. Stop using and contact Baxter or a healthcare provider.

Baxter Healthcare Corporation
Discoloration
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