Biologic Therapies, Inc: Medical Device Recall in 2015 - (Recall #: Z-1374-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Bio-CORE Cannula (Needle) Set

Product Classification:

Class II

Date Initiated: January 23, 2015

Date Posted: April 8, 2015

Recall Number: Z-1374-2015

Event ID: 70445

Reason for Recall:

Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution

Status: Terminated

Product Quantity: 0 (distributed or released)

Code Information:

Catalog Numbers: Part # BCORE.60, BCORE.80, and BCORE.105

Distribution Pattern:

US Distribution in states of: MA, CA, WA, NJ, TX, IL, and FL.

Voluntary or Mandated:

Voluntary: Firm initiated