CLASS I Device recall · Reported 20 Aug 2014 · FDA Enforcement Report
Enhancement Medical expression. model # recalled
Enhancement Medical is recalling Enhancement Medical expression, distributed nationwide in the US. The recall was initiated on 7 Aug 2013 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2135-2014
- FDA event ID
- 68596
- Recalling firm
- Enhancement Medical, Wauwatosa, WI
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 7 Aug 2013
- FDA classified
- 8 Aug 2014
- Reported
- 20 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 7 Aug 2013 | Recall initiated by company | |
| 8 Aug 2014 | Classified by FDA | +366 days |
| 20 Aug 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - USA (nationwide including Puerto Rico) and Internationally to Canada.
Questions about this recall
Is Enhancement Medical expression. model # recalled?
Yes. Enhancement Medical recalled Enhancement Medical expression. model # on 7 Aug 2013. The recall is Class I and its status is Terminated. Recall number Z-2135-2014.
Why was it recalled?
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.
Which lots are affected?
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.
Where was it sold?
Worldwide Distribution - USA (nationwide including Puerto Rico) and Internationally to Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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