The Recall Desk
ModerateFDA (Devices)·Z-0505-2013·Announced 2012-12-19

ConMed Recalls WANG Transbronchial Aspiration Needles Due to Fit Issues

ConMed is recalling WANG Transbronchial Aspiration Needles because they may not fit through a 2.0 mm bronchoscope, causing minor inconvenience.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The source text explicitly states the hazard results in 'minor inconvenience' and requires replacement, fitting the criteria for a moderate severity recall involving low-risk functional issues without reported injury.

Plain-English summary

ConMed Corporation is recalling WANG Transbronchial Aspiration Needles, Catalog No. MW-221, and WANG Cytology Needles. These are disposable, sterile, single-use devices designed for use with a bronchoscope to puncture the tracheobronchial wall and aspirate tissue or cell specimens for staging bronchogenic carcinoma.

The recall was initiated after a user facility reported that the needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. If the device does not fit through the instrument channel, it must be replaced with an alternate device, which could result in minor inconvenience to the user.

A total of 452 units were distributed worldwide, including in the United States (California, Florida, Iowa, Indiana, Massachusetts, Maryland, Maine, Missouri, Mississippi, North Carolina, New Mexico, Ohio, Pennsylvania, and Texas) and foreign countries (Spain, Portugal, Japan, and Hungary). The affected lot codes range from 1209171 to 1209201. Users should check their inventory for these specific lot codes and contact ConMed for replacement if necessary.

The recalled product

Product
WANG Transbronchial Aspiration Needles Cat. No. MW-221, WANG Cytology Needles, Central or Peripheral Regions, 21 g x 15 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use with
Manufacturer
ConMed Corporation
Affected units
452

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • Beginning Lot Code 1209171
  • 09 represents the month (September)
  • 17 is the day of the month
  • and 1 is the Manufacturing Shift Code (1
  • 2
  • 3
  • 4
  • 5
  • 6 or 9).

Distribution

Distributed in 14 states:

Part of a larger recall action

This product is one of 4 recalled by ConMed Corporation 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 4 products in this recall →