Intersurgical Airway Connector Recalled for Potential Swivel Elbow Cracking
Intersurgical Inc is recalling 19,200 airway connectors because the swivel elbow port may crack and leak.
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 hazard involves a risk-of-harm product (airway connector) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Intersurgical Inc is recalling 19,200 units of the Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port (REF 3503031). The affected airway connectors were distributed nationwide in the United States. The specific lot numbers involved in this recall are 2180531, 2181808, 2182241, and 2182533.
The recall was initiated because the port may crack in the swivel elbow where the flip cap is inserted. If these cracks reach a significant size, they could possibly leak. This defect poses a risk to patients using the device for airway management.
Healthcare facilities and consumers should stop using the affected airway connectors immediately. Users should check their inventory for the specific reference number and lot numbers listed above. Intersurgical Inc is the recalling firm responsible for managing this Class II recall.
The recalled product
- Product
- Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. Airway connector.
- Manufacturer
- Intersurgical Inc
- Affected units
- 19,200
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 (4)
- Lot numbers: 2180531
- 2181808
- 2182241
- 2182533
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Intersurgical Inc 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 4 products in this recall →Related recalls
Same manufacturer · Intersurgical Inc
See all →- HighIntersurgical Recalls One-Piece Guedel Airway Devices Due to Occlusion Risk
FDA (Devices) · 2026-08-26
- HighIntersurgical Recalls One-Piece Guedel Airway Devices Due to Occlusion Risk
FDA (Devices) · 2026-08-26
- HighSize 2 Guedel airways may carry small burrs that could detach
FDA (Devices) · 2025-08-13
- HighGuedel airways may carry small burrs that could detach and be inhaled
FDA (Devices) · 2025-08-13
- Severei-view video laryngoscopes may be faulty because of depleted batteries
FDA (Devices) · 2025-07-23
Same hazard · cracking
See all →- HighStryker Hoffmann II Connecting Rod Micro May Crack After Cleaning and Sterilization
FDA (Devices) · 2026-08-05
- HighStryker Hoffmann II Connecting Rod Micro May Crack After Cleaning and Sterilization
FDA (Devices) · 2026-08-05
- HighSurgical access port kits recalled over trays that may crack
FDA (Devices) · 2026-01-21
- HighAdirondack patio chairs recalled because they can crack and collapse
CPSC · 2026-01-15
- ModerateLiquid adhesive vials recalled because the butyrate tube cracks during actuation
FDA (Devices) · 2026-01-07