Teleflex Medical Recalls Humidifier Adaptor 040 Due to Packaging Seal Issues
Teleflex Medical is recalling Humidifier Adaptor 040 units because creased packaging seals may affect integrity. The recall covers 7,758,650 units distributed worldwide.
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 recall is classified as FDA Class II, but the hazard is limited to packaging integrity (creased seals) with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Teleflex Medical is recalling the Humidifier Adaptor 040, a respiratory gas humidifier adaptor. The recall is due to a defect where the seals of the adaptor packaging may be creased, which may potentially affect packaging integrity.
The recall involves 7,758,650 units. The affected product codes are 000-40, and the specific lot numbers are AA19, AB12, AC20, AE03, AE18, AE21, AF09, AF16, AG10, AG12, and AH11. The products were distributed nationwide in the United States and in Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, the Philippines, Singapore, Thailand, and Zambia.
The FDA has classified this as a Class II recall. Consumers and healthcare facilities should check their inventory for the specific lot numbers listed and contact Teleflex Medical for instructions on how to proceed.
The recalled product
- Product
- Humidifier Adaptor 040, Teleflex Medical, respiratory gas humidifier adaptor.
- Manufacturer
- Teleflex Medical
- Hazard
- Affected units
- 7,758,650
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)
- Product Code: 000-40
- Lot numbers: AA19
- AB12
- AC20
- AE03
- AE18
- AE21
- AF09
- AF16
- AG10
- AG12 & AH11.
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.
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