The Recall Desk

Manufacturer

RM Temena GmbH

2 recalls in our database name RM Temena GmbH as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2014-05-21

Of the 2 recalls from RM Temena GmbH we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Devices)·Z-1609-2014·2014-05-21

    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.

    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
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1608-2014·2014-05-21

    FDA Recalls Defective Ultrasound Needles That May Leak at Hub

    RM Temena GmbH is recalling 7,370 ultrasound needles that may leak at the needle hub. The defective needles were distributed in Maryland and Illinois.

    Product
    Ultrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 needles/box, item number REF USC050-22. Needles for peripheral nerve blocking under ultrasound guidance.
    Category
    Medical Device
    Distribution
    2 states