The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0784-2020·Announced 2020-01-15

Intersurgical Double Swivel Elbow Airway Connectors Recalled for Cracking Risk

Intersurgical Inc is recalling 115,200 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 the hazard involves a potential leak in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Intersurgical Inc is recalling 115,200 pieces of Double Swivel Elbow with Bronchoscopy Port airway connectors (REF 1898000). The affected products are distributed nationwide in the United States.

The recall is due to a defect where the port may crack in the swivel elbow where the flip cap is inserted. These cracks could possibly leak if they reach a significant size. The specific lot numbers involved are 2181793, 2182007, 2182830, 2183105, 2183345(3183345), 2190034, 2190139, 2191204, and 2191327.

Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices. Users should contact Intersurgical Inc for further instructions on how to return or dispose of the recalled products.

The recalled product

Product
Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector.
Manufacturer
Intersurgical Inc
Category
Medical Device — Airway Connector
Hazard
Affected units
115,200

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 (9)

  • Lot numbers: 2181793
  • 2182007
  • 2182830
  • 2183105
  • 2183345(3183345)
  • 2190034
  • 2190139
  • 2191204
  • 2191327

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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