CLASS II Device recall · Reported 21 May 2014 · FDA Enforcement Report
Ultrasound USB needles, with 30 degree bevel recalled by RM Temena
RM Temena is recalling Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, distributed in Illinois, Maryland. The recall was initiated on 19 Mar 2014 and the FDA has classified it as Class II.
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-1609-2014
- FDA event ID
- 68026
- Recalling firm
- RM Temena, Felsberg
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Mar 2014
- FDA classified
- 12 May 2014
- Reported
- 21 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Imaging Equipment
Timeline
| 19 Mar 2014 | Recall initiated by company | |
| 12 May 2014 | Classified by FDA | +54 days |
| 21 May 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Ultrasound needles may be defective and leak at the needle hub.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REF USB050-22. Needles for peripheral nerve blocking under ultrasound guidance
Where it was distributed
US Distribution including the states of MD and IL.
Questions about this recall
Why was it recalled?
Ultrasound needles may be defective and leak at the needle hub.
Which lots are affected?
Lot B3070012 EXP 2018-02-28 Lot B3250001 EXP 2018-06-30 Lot B3250026 EXP 2018-06-30
Where was it sold?
US Distribution including the states of MD and IL.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 68026| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ultrasound needles, packaged individually, 10 needles/box recalled | RM Temena | Packaging Defects | IL, MD |
More recalls from RM Temena
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Ultrasound needles, packaged individually, 10 needles/box recalled | RM Temena | Packaging Defects | IL, MD |
Other Imaging Equipment recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled | Canon Medical System USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederl | Potency & Assay |