The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0785-2020·Announced 2020-01-15

Intersurgical Double Swivel Elbow Airway Connectors Recalled for Potential Cracking

Intersurgical Inc is recalling 46,450 Double Swivel Elbow airway connectors because the port may crack and leak.

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 involves a risk-of-harm product (airway connector) where injury has not yet been reported, meeting the criteria for a High severity score.

Plain-English summary

Intersurgical Inc is recalling 46,450 pieces of the Double Swivel Elbow with Bronchoscopy Port (REF 1996030). The affected lots are 2180448, 2180742, and 2181001. These airway connectors were distributed nationwide in the United States.

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 is classified as an FDA Class II recall.

Healthcare facilities and consumers should stop using the affected products and contact Intersurgical Inc for instructions on return or replacement.

The recalled product

Product
Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996030. Airway connector.
Manufacturer
Intersurgical Inc
Category
Medical Device — Airway Management
Hazard
Affected units
46,450

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)

  • Lot numbers: 2180448
  • 2180742
  • 2181001

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 →

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