Intersurgical Inc

FDA recalling firm · 8 enforcement events · 13 product records · 2017–2026 · NY

Intersurgical Inc has 8 FDA enforcement events on this register (13 product records) between 2017 and 2026: 8 device; the busiest year was 2025 with 2.

13% of its events are Class I; the most common class is Class II (7). 3 events are listed as ongoing; the recalling firm's address is in NY.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
15 Jun 2026	One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.	Device	Class II	2	Ongoing
20 Jun 2025	One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.	Device	Class II	2	Ongoing
17 Jun 2025	i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.	Device	Class I	1	Ongoing
29 Aug 2022	Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000	Device	Class II	1	Terminated
11 Nov 2020	Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Breathing Systems - Product Usage: intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a…	Device	Class II	1	Terminated
7 Aug 2019	Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector.	Device	Class II	4	Terminated
25 Apr 2018	Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000	Device	Class II	1	Terminated
3 Apr 2017	Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pediatric size 2.5 catalog #8025001, 3) small adult size 3 catalog #8003001, 4) medium adult size 4 catalog #8004001 and 5) large adult size 5 catalog #8005001 Patent airway management.	Device	Class II	1	Terminated

By type and class

Device8

Class II7

Class I1

Class I: 13% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Intersurgical Inc by year initiated.

Questions and answers

How many FDA recalls has Intersurgical Inc had?

8 enforcement events (13 product records) on this register, 2017–2026: 8 device.

Are any Intersurgical Inc recalls ongoing?

3 events are listed as ongoing in the current openFDA export.

What class are Intersurgical Inc recalls?

7 Class II, 1 Class I. 13% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.