Agency classClass IIOur severity:High FDA (Devices)·Z-1102-2015·Announced 2015-02-18

Teleflex Medical Recalls Aqua 540 Humidifier Adaptors Due to Foreign Material

Teleflex Medical is recalling Aqua 540 Humidifier Adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where the presence of foreign material poses a potential injury risk, though no specific injuries or illnesses are reported in the source text.

Plain-English summary

Teleflex Medical is recalling the Aqua 540 SW and 540 W/040 Humidifier Adaptors. The recall is being conducted because the packages may contain foreign material, specifically black particles. The Humidifier Adaptor is an accessory used to connect sterile water or sterile saline to a humidifier circuit for inhalation therapy. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

The recall involves 15,779,607 units. The affected products were distributed nationwide in the United States and in numerous countries worldwide, including Australia, Canada, Germany, Japan, and the United Kingdom. The agency has classified this recall as Class II.

Healthcare providers and consumers should stop using the affected Aqua 540 Humidifier Adaptors immediately. Users should check their inventory for the specific product code 005-40 and the listed lot numbers to determine if they have affected units. Teleflex Medical is the recalling firm responsible for managing the recall process.

The recalled product

Product: AQUA 540 SW, 540 W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with…
Manufacturer: Teleflex Medical
Category: Medical Device — Respiratory Therapy
Hazard: foreign-material
Affected units: 15,779,607

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 (20)

Product Code: 005-40
Lot numbers: 005135
015135
017135
029135
010135
035135
006145
003135
018135
034135
019135
023135
028135
010145
004145
008135
009145
002145
030135

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 15 recalled by Teleflex Medical 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 15 products in this recall →

Same manufacturer · Teleflex Medical

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Same hazard · foreign material