Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0502-2013·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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 recall is classified as FDA Class II, but the source explicitly states the hazard results in 'minor inconvenience' with no reported injuries or illnesses, fitting the Moderate criteria for low-risk issues.

Plain-English summary

ConMed Corporation is recalling WANG Transbronchial Aspiration Needles (Cat. No. MW-222) and WANG Cytology Needles. The recall involves 452 units distributed worldwide, including the United States and several foreign countries.

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. The source text states that if the device does not fit, it must be replaced with an alternate device, which could result in minor inconvenience to the user.

Affected lot codes range from 1207251 to 1207251 and from 1209171 to 1210151. Users should check their inventory for these specific lot codes and replace any affected devices with alternate equipment as necessary.

The recalled product

Product: WANG Transbronchial Aspiration Needles Cat. No. MW-222, WANG Cytology Needles, Central or Peripheral Regions, 22 g x 13 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use…
Manufacturer: ConMed Corporation
Category: Medical Device — Bronchoscope Accessories
Hazard: device-malfunction
incompatibility
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 (11)

Begining Lot 1207251
Ending Lot Code 1207251
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 →

Same manufacturer · ConMed Corporation

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