cpsc regulated Recalls

1,716 recalls tagged with “cpsc regulated”.

Health & Personal Care
HIGH
FDA DEVICE

CorNeat Vision Recalls Surgical Matrix Over High Dehiscence Risk

CorNeat Vision recalled 630 units of the EverPatch surgical matrix on August 18, 2025. The recall follows complaints of conjunctival wound dehiscence leading to potential exposure of the surgical patch. The product was distributed worldwide, including across numerous U.S. states.

CorNeat Vision
Reviewed complaints
Read more
Health & Personal Care
HIGH
FDA DEVICE

Maquet Cardiovascular Recalls Heartstring III Occluder Due to Failure Risks

Maquet Cardiovascular recalled 32,867 units of the Heartstring III Proximal Seal System on August 15, 2025. Three failure modes can lead to inadequate hemostasis during procedures. Patients and healthcare providers must stop using this device immediately.

Maquet Cardiovascular
Three failure
Read more
Health & Personal Care
HIGH
FDA DEVICE

Exactech Recalls Reverse Shoulder Humeral Liners Over Safety Concerns

Exactech recalled 61,334 units of Reverse Shoulder Humeral Liners on August 15, 2025. The liners do not meet specified dimensional standards, posing a risk to patients. Healthcare providers and patients must stop using the devices immediately.

Exactech
Reverse Shoulder
Read more
Health & Personal Care
HIGH
FDA DEVICE

Maquet Cardiovascular Recalls Heartstring III Occluder Due to High Risk

Maquet Cardiovascular recalled 16,512 Heartstring III Proximal Seal Systems due to critical failure modes. The recall affects devices distributed globally since August 15, 2025. Users must stop using the device immediately and follow manufacturer instructions.

Maquet Cardiovascular
Three failure
Read more
Health & Personal Care
HIGH
FDA DEVICE

Exactech Recalls Reverse Shoulder Humeral Liners Over Hazard

Exactech recalled 11,542 reverse shoulder humeral liners on August 15, 2025. The devices have an articular surface position outside of the specified dimensions. This recall affects units distributed worldwide, including several U.S. states.

Exactech
Reverse Shoulder
Read more
Health & Personal Care
HIGH
FDA DEVICE

Mindray Recalls BeneVision N1 Patient Monitor Over Alarm Issues

Mindray DS USA, Inc. recalled 2,278 BeneVision N1 Patient Monitors on August 15, 2025. The monitors may activate an abnormal alarm pause, compromising patient safety. Health professionals must cease using these devices immediately and follow recall instructions.

Mindray DS USA, Inc.
Potential for
Read more
Food & Beverages
HIGH
FDA FOOD

Anderson Candy Company Recalls Peanut Rounds Over Soy Allergen Risk

Anderson Candy Company recalled 960,000 units of Peanut Rounds on August 15, 2025. The recall stems from undeclared soy allergens that pose a serious health risk. The affected products were distributed in several states including Texas and Louisiana.

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

ETHICON Recalls Tissue Control Device for Barb Non-Engagement Risk

ETHICON recalled 516 units of the STRATAFIX Spiral PDS Plus device on August 15, 2025. The recall follows reports of potential barb non-engagement that could affect surgical procedures. Healthcare providers and patients must stop using the device immediately.

ETHICON
Potential for
Read more
Health & Personal Care
HIGH
FDA DEVICE

Philips CT System Recalled Due to Hazardous Component Misalignment

Philips recalled 14 Brilliance iCT SP CT systems on August 13, 2025. The patient support table may descend unexpectedly due to a component misalignment. The recall affects devices distributed worldwide, including the US and 49 other countries.

Philips North America
The patient
Read more
Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter Recalls Hematology Analyzers Due to High HGB Risk

Beckman Coulter recalled its UniCel DxH 800 COULTER Cellular Analysis System on August 13, 2025. This recall affects devices that may produce inaccurately high hemoglobin results in patients with high white blood cell counts. The recall impacts worldwide distribution including numerous states in the U.S. and many countries.

Beckman Coulter
Hematology analyzers
Read more
Health & Personal Care
HIGH
FDA DEVICE

Philips CT System Recalled Due to Patient Safety Hazard

Philips recalled 210 Brilliance iCT CT systems on August 13, 2025. A misalignment in the ball screw may cause the patient support table to descend unexpectedly. Patients and healthcare providers must stop using the device immediately.

Philips North America
The patient
Read more
Health & Personal Care
HIGH
FDA DEVICE

Philips Recalls CT Systems Due to Fall Hazard

Philips recalled 81 IQon Spectral CT systems on August 13, 2025, due to a potential fall hazard. The patient support table may descend unexpectedly due to a ball screw misalignment. Healthcare providers and patients must stop using the device immediately.

Philips North America
The patient
Read more
Health & Personal Care
HIGH
FDA DEVICE

Philips CT System Recalled Due to Unexpected Descent Hazard

Philips recalled 6 CT 6000 systems on August 13, 2025. The patient support table may descend unexpectedly due to a ball screw misalignment. This recall affects devices distributed worldwide, including the U.S.

Philips North America
The patient
Read more
Health & Personal Care
HIGH
FDA DEVICE

Philips Recalls CT Systems Over Hazardous Couch Descent

Philips recalled 33 CT systems on August 13, 2025, due to a risk of the patient support table descending unexpectedly. A misalignment in the ball screw can cause the couch to drop to its lowest position. The recall affects models distributed worldwide, including the U.S. and numerous countries.

Philips North America
The patient
Read more
Food & Beverages
HIGH
FDA FOOD

Fresh & Ready Foods Recalls Sandwiches Over Wheat Allergen Risk

Fresh & Ready Foods recalled 233 units of ready to eat sandwiches on August 13, 2025. The recall stems from undeclared wheat allergens that pose a serious risk to consumers. The sandwiches were distributed to 15 corporate locations in California.

Fresh & Ready Foods
undeclared allergen
Read more
Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter Hematology Analyzer Recalled for High HGB Risk

Beckman Coulter recalled the UniCel DxH 900 COULTER Cellular Analysis System on August 13, 2025, due to erroneous high hemoglobin results. The devices may misreport hemoglobin levels on samples with elevated white blood cell counts. This recall affects devices distributed worldwide, including the U.S.

Beckman Coulter
Hematology analyzers
Read more
Health & Personal Care
HIGH
FDA DEVICE

Philips Recalls CT Systems Over Risk of Unexpected Descent

Philips recalled three Ingenuity CT Family systems on August 13, 2025, due to a hazard that could lead to sudden descent. The issue stems from a ball screw misalignment affecting the patient support table. Users should stop using the devices immediately and follow recall instructions.

Philips North America
The patient
Read more