Enhancement Medical, LLC: Medical Device Recall in 2014 - (Recall #: Z-2135-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml. Product Usage: Expression is labelled as an Intranasal Splint, intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. However, Expression is currently being used off-label as a subcutaneously injected dermal filler.

Product Classification:

Class I

Date Initiated: August 7, 2013

Date Posted: August 20, 2014

Recall Number: Z-2135-2014

Event ID: 68596

Reason for Recall:

Manufacturer made a change in the production process that resulted in a change in final gel weight. RECALL EXPANDED 7/8/2014 Firm expanded their recall to include all lots of product.

Status: Terminated

Product Quantity: 17,875

Code Information:

Lot numbers to follow: Z36-074, Q36-136, Q36-137, Q36-138, Q36-139, Q36-140, R36-168, R36-169, R36-170, R36-171, R36-172, S36-189, S36-190, S36-191, S36-192, S36-194, S36-202, S36-203. RECALL EXPANDED 7-8-2014 to include ALL LOTS.

Distribution Pattern:

Worldwide Distribution - USA (nationwide including Puerto Rico) and Internationally to Canada.

Voluntary or Mandated:

Voluntary: Firm initiated