Intersurgical, Inc.
United StatesFDA applicant, unverified FDA FEI 1000120301
Part of Intersurgical Ltd
- Devices
- 18
- Registrations
- FDA
- FDA recalls
- 145 ongoing
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
Catalogue
Search and filter all 18 devicesCompany details
- FDA FEI number
- 1000120301
- Address
- 5010 Campuswood Dr, Ste 102, East Syracuse, NY, 13057
FDA recalls
Recalls initiated per year
- 2017 1
- 2018 1
- 2019 4
- 2020 1
- 2021 0
- 2022 1
- 2023 0
- 2024 0
- 2025 3
- 2026 2
2026
- 15 Jun 2026 Z-2952-2026 Class II Ongoing Devices could potentially be occluded or partially occluded.
- 15 Jun 2026 Z-2953-2026 Class II Ongoing Devices could potentially be occluded or partially occluded.
2025
- 20 Jun 2025 Z-2275-2025 Class II Ongoing 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.
- 20 Jun 2025 Z-2276-2025 Class II Ongoing 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.
- 17 Jun 2025 Z-2102-2025 Class I Ongoing Potential for faulty devices as a result of depleted batteries.
2022
- 29 Aug 2022 Z-0096-2023 Class II Terminated 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 balloon) may pose health risk to the patient
2020
- 11 Nov 2020 Z-0753-2021 Class II Terminated The device was assembled with the incorrect exhalation port which can cause gas leakage.
2019
- 7 Aug 2019 Z-0784-2020 Class II Terminated 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.
- 7 Aug 2019 Z-0785-2020 Class II Terminated 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.
- 7 Aug 2019 Z-0786-2020 Class II Terminated 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.
Show all 14 recalls
2019
- 7 Aug 2019 Z-0787-2020 Class II Terminated 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.
2018
- 25 Apr 2018 Z-2302-2018 Class II Terminated 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.
2017
- 3 Apr 2017 Z-0208-2018 Class II Terminated A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.
Full distribution text
- 3 Apr 2017 Z-0208-2018 Class II Terminated A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.
2011
- 9 Feb 2011 Z-0518-2012 Unclassified (pre-2012) Terminated Intersurgical Incorporated has issued a voluntary recall of the IS Cans Carbon Dioxide Absorber due to a possibility that loose granules may enter the inspiratory path of the breathing system.
Full distribution text
- 9 Feb 2011 Z-0518-2012 Unclassified (pre-2012) Terminated Intersurgical Incorporated has issued a voluntary recall of the IS Cans Carbon Dioxide Absorber due to a possibility that loose granules may enter the inspiratory path of the breathing system.
Frequently asked questions
How many devices does Intersurgical, Inc. have in the registry?
The registry currently lists 18 devices for Intersurgical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Intersurgical, Inc.'s devices?
Among its 18 most recently registered devices, Intersurgical, Inc. has devices listed in FDA 510(k) (18 devices).
What risk classes do Intersurgical, Inc.'s devices fall under?
Among its 18 most recently registered devices, the classes recorded for Intersurgical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Intersurgical, Inc.?
FDA recall records list 14 recalls initiated by Intersurgical, Inc., the most recent initiated on 15 Jun 2026. 5 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Intersurgical, Inc. in the registry?
The most recently registered devices listed for Intersurgical, Inc. include MANOMETER, DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER, CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT, CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT, CLEAR-GUARD 3 F3 and FLO-GUARD BREATHING FILTER.