Facility

INTERSURGICAL, INC.

8 recall(s) on record — most severe on record: Class I.

Key facts

8recalls · worst Class I

3inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1000120301
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	5010 Campuswood Dr, Ste 102 East Syracuse, NY, US 13057
Registration status	Active · expires 2026
Parent company	INTERSURGICAL, INC. (owner-operator 9002725)
Brand names	8006005; Solus Laryngeal Mask, 8001032, 8002032, 8003032, 8004032, 8005032, 8015032, 8025032; 8006007; Solus Flexible laryngeal mask airway, 8001006, 8015006, 8002006, 8025006, 8003006, 8004006, 8005006, 8006006; Solus Silicone laryngeal mask airway, 8015004, 8002004, 8025004, 8003004, 8004004, 8005004, 8006004; Solus Flexible laryngeal mask airway with AccuCuff, 8001007, 8015007, 8002007, 8025007, 8003007, 8004007, 8005007; Solus Silicone laryngeal mask airway with AccuCuff, 8001005, 8015005, 8002005, 8025005, 8003005, 8004005, 8005005

Activity by year

Recalls (8)
Inspections (3)

Devices registered here (1)

Airway, Oropharyngeal, Anesthesiology
Product code CAE (opens in a new tab) · Class I · Anesthesiology · 21 CFR 868.5110

Recalls & enforcement

Class IIOngoing2026-06-15
Devices could potentially be occluded or partially occluded.
Class IIOngoing2025-06-20
Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.
Class IOngoing2025-06-17
Potential for faulty devices as a result of depleted batteries.
Class IITerminated2022-08-29
Printing error on the device, size 3 Solus Standard laryngeal mask airway has been incorrectly marked with size 4 information (includes the number 4 as a size identifier, patient weight and maximum inflation volume on the airway tube and the marking #4 on the inflation line pilot…
Class IITerminated2020-11-11
The device was assembled with the incorrect exhalation port which can cause gas leakage.
Class IITerminated2019-08-07
The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.
Class IITerminated2018-04-25
When assembling an HME or Filter on this breathing circuit the tubing may be pushed up and inadvertently cover or block the exhalation port. This could potentially pose a serious health risk to the patient.
Class IITerminated2017-04-03
A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.

FDA inspections (3)

NAI2024-09-11
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2018-11-01
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2016-11-18
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by INTERSURGICAL, INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “INTERSURGICAL, INC. (FEI 1000120301) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000120301-intersurgical-inc/

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