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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68026

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 19, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
RM Temena GmbH

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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.

Z-1608-2014
Recall number
Z-1608-2014
Initiated
March 19, 2014
Classification
Class II
Status
Terminated
Recalling firm
RM Temena GmbH
Quantity
7370 needles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ultrasound needles may be defective and leak at the needle hub.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ultrasound needles may be defective and leak at the needle hub.

Code information

Lot B3170005, EXP 2018-05-31

Distribution pattern

US Distribution including the states of MD and IL.

device · product 2 of 2

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

Z-1609-2014
Recall number
Z-1609-2014
Initiated
March 19, 2014
Classification
Class II
Status
Terminated
Recalling firm
RM Temena GmbH
Quantity
7370 needles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ultrasound needles may be defective and leak at the needle hub.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ultrasound needles may be defective and leak at the needle hub.

Code information

Lot B3070012 EXP 2018-02-28 Lot B3250001 EXP 2018-06-30 Lot B3250026 EXP 2018-06-30

Distribution pattern

US Distribution including the states of MD and IL.