Z-2135-2014Class I

Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid...

Name: Z-2135-2014 Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid...
Creator: Enhancement Medical, LLC
Published: 2013-08-07
License: https://open.fda.gov/license/

Enhancement Medical, LLC / initiated 2013-08-07 / Terminated / root cause: design

FDA source

Enhancement Medical, LLC began a recall of Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml. Product Usage: Expression is... on 2013-08-07. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2135-2014
Classification: Class I
Status: Terminated
Initiated: 2013-08-07
Posted: 2014-08-08
Terminated: 2017-09-29
Recalling firm: Enhancement Medical, LLC
Product: 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 code: LMH Implant, Dermal, For Aesthetic Use
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.
Root cause tag: design
FDA root cause: Device Design
Action: Enhancement Medical, LLC called all Independent Sales Representatives and then provided each representative a list of consignees with impacted product and instructed the Representatives to disclose low gel weight issue and potential for common treatment responses. Representatives were instructed to exchange the affected product. EXPANDED Enhancement Medical sent an Urgent Medical Device Recall letter beginning July 8, 2014 to all consignees whom received product. The letter identified all lots as being recalled, the reason for the recall, recommended that Expression not be injected subcutaneously, and asked for product to no longer be used and be returned to the recalling firm. An acknowledgement Form was asked to be mailed, e-mailed or faxed back to the firm. Customers with questions were instructed to call 414-918-4280.
Quantity in commerce: 17,875
Distribution: Worldwide Distribution - USA (nationwide including Puerto Rico) and Internationally to Canada.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2135-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2135-2014	Class I	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-08

Product code LMH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)