Teleflex Medical Recalls Aquapak Nebulizer Adaptors Due to Seal Integrity Concerns
Teleflex Medical is recalling Aquapak nebulizer adaptors because packaging seals may be open or weak, potentially affecting the sterility of the device.
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 the hazard involves a risk of harm (loss of sterility) for a medical device where injury has not yet been reported.
Plain-English summary
Teleflex Medical is recalling specific lots of Aquapak nebulizer adaptors used in anesthesiology. The recall involves approximately 3.2 million units distributed worldwide, including the United States and numerous international markets.
The recall was initiated because the nebulizer adaptor packaging may have open or weak seals. This defect may affect the sterility of the adaptor, which is a critical safety requirement for medical devices used in clinical settings.
Healthcare facilities and distributors should check their inventory for the specific product numbers and lot numbers listed in the official FDA recall notice. Affected units should be removed from service and returned to Teleflex Medical according to the company's instructions.
The recalled product
- Product
- Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070 ML/W028 Adaptor, Intl, Product No. 404128; Aqauapak 428 SW, 440 ML W/028 Adaptor, Intl, Product No. 404428; Aquapak 728 SW, 760 ML W/028 Adaptor, Product No. 037-28; Aquapak SW/EAU Sterile…
- Manufacturer
- Teleflex Medical
- Category
- Medical Device — Anesthesiology
- Affected units
- 3,193,548
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 No. 403728
- Lot #104120
- 114120
- 132120
- 120120
- 155120
- 158120
- 144120
- 164120
- 008130
- 013130
- 023130
- 035130
- 038130
- 049130
- 060130
- 072130
- 054130
- 100130
- 115130
Distribution
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
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Same hazard · sterility compromise
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