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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78207

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 26, 2014
Product types
Device
Classifications
Class II
Statuses
Completed
Recalling firm wording
Teleflex Medical

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

1 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 1

Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.

Z-0039-2018
Recall number
Z-0039-2018
Initiated
September 26, 2014
Classification
Class II
Status
Completed
Recalling firm
Teleflex Medical
Quantity
6197 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The knife handles slot depth is out of specification, so blades may not fit on the handles properly.

Code information

a) REF 352950: Lot numbers: D6, J6, E6, F6, G6, H6, I6 b) REF 352953: Lot numbers: I6, B6, E6 c) REF 352951: Lot numbers: I6, J6 d) REF 352957: Lot numbers: A6, B6, B7, K6, L6 e) REF 352952: Lot numbers: H6

Distribution pattern

Worldwide Distribution: US (Nationwide) and countries of: Canada, France, Taiwan, Argentina, Australia, S. Korea, Belgium, Singapore, India, Indonesia, Philippines and Thailand.