INSPIRA AIR Balloon Dilation System packaging error corrected nationwide
Integra LifeSciences is recalling INSPIRA AIR Balloon Dilation System 10x40 cartons because an incorrect product was packaged inside. The recall affects six units distributed across Texas, Montana, Alabama, and Oklahoma.
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 FDA has classified this as a Class II recall. The source text states only that an incorrect product was packaged in the carton with no reported illnesses, injuries, or deaths, making this a moderate-severity labeling/packaging error.
Plain-English summary
Integra LifeSciences Corp. (NeuroSciences) is recalling INSPIRA AIR Balloon Dilation System 10x40, 1 PK, an airway balloon dilation catheter. The reason for recall is that an incorrect product was packaged in the INSPIRA AIR Balloon Dilation System carton.
Six units of the affected product (Model No. BC1040AZ, Lot No. 240716A-PC) were distributed in the United States to locations in Texas, Montana, Alabama, and Oklahoma.
Patients or healthcare providers who have received this product should contact Integra LifeSciences Corp. (NeuroSciences) for further instructions regarding the incorrect product.
The recalled product
- Product
- INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Affected units
- 6
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 (3)
- Model No. BC1040AZ
- UDI: 20705031063157
- Lot No. 240716A-PC.
Distribution
Related recalls
Same manufacturer · Integra LifeSciences Corp. (NeuroSciences)
See all →- ModerateOmniTract Surgical Retractor System sterilization instructions require extended dry time
FDA (Devices) · 2026-07-15
- ModerateCodman CerebroFlo EVD Catheter recalled for out-of-specification endotoxin
FDA (Devices) · 2026-05-20
- ModerateCUSA Clarity C7000 Ultrasonic Surgical Aspirator Touch Screen Unresponsiveness
FDA (Devices) · 2026-04-29
- HighCytal Burn Matrix 10x15 cm recalled over out-of-specification endotoxin results
FDA (Devices) · 2026-04-22
- HighCytal Wound Matrix 10x15 cm recalled over out-of-specification endotoxin results
FDA (Devices) · 2026-04-22
Same hazard · packaging error
See all →- ModerateTerumo Glidesheath Slender A-Kit Recalled for Incorrect Guidewire Packaging
FDA (Devices) · 2026-08-19
- LowRio II Nasal Pillows Interface Packaging and Labeling Discrepancy Recall
FDA (Devices) · 2026-07-22
- ModerateEMPOWR 3D KNEE insertion instruments recalled for incorrect product size packaging
FDA (Devices) · 2026-07-15
- ModerateArtegraft vascular graft recalled over incorrect lot outer packaging labeling
FDA (Devices) · 2026-03-25
- ModerateBD syringe batch may contain Luer Slip instead of Luer Lok
FDA (Devices) · 2026-03-18
Similar recalls
- ModerateAcclarent Inspira AIR Balloon Dilation System Labeling Correction Recall
FDA (Devices) · 2013-08-07
- ModerateAcclarent Recalls Inspira AIR Balloon Dilation System for Labeling Corrections
FDA (Devices) · 2013-08-07
- HighBoston Scientific Recalls NephroMax Balloon Catheter Kits Due to Packaging Error
FDA (Devices) · 2013-07-17
- HighAeris Balloon Dilation Catheter Mislabeled — FDA Class II Recall
FDA (Devices) · 2023-07-26
- HighBard Conquest 40 PTA Dilation Catheter Recalled for Packaging Error
FDA (Devices) · 2020-02-05
- ModerateCook Inc. Recalls Advance 35LP Balloon Catheters Due to Labeling Error
FDA (Devices) · 2018-05-02