Enhancement Medical expression — Class I medical device recall Z-2135-2014
Terminated recall by Enhancement Medical, LLC, reported 2014-08-20, distributed nationwide. Manufacturer made a change in the production process that resulted in a change in final gel weight. RECALL EXP
| Recall number | Z-2135-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Enhancement Medical, LLC, Wauwatosa, WI, United States |
| Recall initiated | 2013-08-07 |
| Classified | 2014-08-08 |
| Reported by FDA | 2014-08-20 |
| Terminated | 2017-09-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 17,875 |
| Model numbers | 150 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2135-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.