FDA Recalls Defective Ultrasound Needles That May Leak at Hub
RM Temena GmbH is recalling ultrasound needles that may leak at the hub. The recall involves 7,370 needles distributed in the US.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, a Class II recall without explicit reports of hospitalization or significant injury falls into the 'High' category (Score 3), representing a risk of harm where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for ultrasound needles manufactured by RM Temena GmbH. The affected product consists of ultrasound USB needles with a 30-degree bevel, packaged individually in boxes of 10, under item number REF USB050-22. These needles are intended for peripheral nerve blocking under ultrasound guidance.
The recall is due to a defect where the needles may leak at the needle hub. The recall covers 7,370 needles. The affected lots are B3070012 (expiration date 2018-02-28), B3250001 (expiration date 2018-06-30), and B3250026 (expiration date 2018-06-30). The products were distributed in the United States, including the states of Maryland and Illinois.
Healthcare providers and consumers should stop using these needles and contact RM Temena GmbH for further instructions or a refund. The FDA classifies this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- 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
- Manufacturer
- RM Temena GmbH
- Category
- Medical Device — Needles
- Hazard
- Affected units
- 7,370
Distribution
Part of a larger recall action
This product is one of 2 recalled by RM Temena GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · RM Temena GmbH
See all →- HighFDA Recalls Defective Ultrasound Needles That May Leak at Hub
FDA (Devices) · 2014-05-21
Same hazard · leakage
See all →- HighConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
FDA (Devices) · 2026-08-26
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
- SevereABIOMED Introducer Kit 23 Fr heart pump accessory leakage risk
FDA (Devices) · 2026-07-22