infant product Recalls

228 recalls tagged with “infant product”.

Health & Personal Care
HIGH
FDA DEVICE

Summa Therapeutics Recalls 22 Finesse BTK Multicath Angioplasty Balloons Over Burst Specifications (

Summa Therapeutics recalled 22 units of the Finesse BTK Multicath Injectable Angioplasty Balloon Catheter sold to healthcare facilities in New Jersey and Florida. The balloon may not meet burst specifications, raising risk during angioplasty. Healthcare providers must stop using the device immediately and follow recall instructions from Summa Therapeutics.

Finesse BTK Multicath
Potential for
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Recalled Creekliybear "Pack and Play" Aftermarket Play Yard Mattress
MEDIUM
CPSC

Creekliybear Play Yard Mattresses Recalled Over Entrapment Risk

Creekliybear recalled aftermarket play yard mattresses on July 10, 2025, due to a serious entrapment hazard. The mattresses exceed thickness requirements and do not fit securely in some play yards, posing a suffocation risk. Consumers should stop using them immediately and return for a full refund.

Creekliybear
The aftermarket
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Health & Personal Care
HIGH
FDA DEVICE

Surepulse Medical Issues Recall for Newborn Heart Rate Monitor Component

Surepulse Medical recalled the VS Cap Small component of its newborn heart rate monitor on January 20, 2023. The recall stems from incorrect sizing information provided on the product label. This defect poses a significant risk to patient safety.

SUREPULSE MEDICAL
Retroactively reported;
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