FDA Device recall Z-2135-2014
Enhancement Medical expression. model # EXP-150
- FDA Device
- Class I
- terminated
- Published 2014-08-20
On 2014-08-20 the FDA classified a Class I recall of Enhancement Medical expression. model # EXP-150 by Enhancement Medical, citing 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 prod….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2135-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-08-07 |
| Published | 2014-08-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Enhancement Medical |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | Lot numbers to follow: Z36-074, Q36-136, Q36-137, Q36-138, Q36-139, Q36-140, R36-168, R36-169, R36-170, R36-171, R36-1…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2135-2014%22
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