Teleflex Recalls Mucosal Atomization Devices Due to Incomplete Atomization
Teleflex Medical is recalling Mucosal Atomization Devices because they may produce a straight stream instead of a fully atomized plume of medication.
What this means for you
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 defect involves a risk-of-harm product where the medication delivery mechanism is compromised, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Teleflex Medical is recalling specific lots of Mucosal Atomization Devices (MAD) manufactured by Wolfe-Tory Medical, Inc. The affected products include various product codes such as MAD100, MAD110, MAD130, MAD140, and MAD300, along with their OS and B variants. The recall involves 2,674,650 units that were distributed nationwide in the United States and internationally to Canada, Belgium, Singapore, and Thailand.
The recall was initiated because the devices may produce a straight stream of medication instead of a fully atomized plume. This defect affects the intended delivery method of topical solutions across the naso and oropharyngeal mucosal membranes. The FDA has classified this recall as Class II, indicating a situation where use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should stop using the affected Mucosal Atomization Devices and contact Teleflex Medical for instructions on how to return the products or obtain replacements. Specific batch and lot numbers are listed in the official recall notice to help identify affected units.
The recalled product
- Product
- Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS MAD110, MAD110OS, MAD130, MAD130OS, MAD140, MAD140OS, MAD300, MAD300B. Manufactured By: Wolfe-Tory Medical, Inc., Teleflex Medical. For atomiz
- Manufacturer
- Teleflex Medical
- Affected units
- 2,674,650
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 (20)
- Product code MAD100
- Batch/Lot numbers 160105
- 160137
- 160302
- 160321
- 160402
- 160435
- 160506
- 160523
- 160609
- 160620
- 160707
- 160802
- 160813
- Product code MAD100OS
- Batch/Lot numbers 160322
- 160524
- 160630
- Product code MAD110
- Batch/Lot numbers 160217
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 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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