Food, drugs, devices › Intersurgical Inc
Device recall: Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multi
FDA enforcement event 86800 is a device recall by Intersurgical Inc of East Syracuse, NY, initiated 11 Nov 2020 and classified Class II, with 1 product record.
FDA defines Class II as 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. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 9 Aug 2022. Initiation: voluntary: firm initiated. Intersurgical Inc has 8 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Intersurgical Inc, East Syracuse, NY.
Reason for recall
"The device was assembled with the incorrect exhalation port which can cause gas leakage."
Distribution
"All of the devices were shipped to the same distributor (McKesson)."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0753-2021 | 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… | 200 devices | Class II | Terminated | 6 Jan 2021 |
Context
Other enforcement events for Intersurgical Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 15 Jun 2026 | One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device. | Device | Class II | 2 |
| 20 Jun 2025 | One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080. | Device | Class II | 2 |
| 17 Jun 2025 | i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy. | Device | Class I | 1 |
| 29 Aug 2022 | Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000 | Device | Class II | 1 |
| 7 Aug 2019 | Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector. | Device | Class II | 4 |
| 25 Apr 2018 | Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000 | Device | Class II | 1 |
| 3 Apr 2017 | Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002 | Device | Class II | 1 |
All 8 events for Intersurgical Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The device was assembled with the incorrect exhalation port which can cause gas leakage."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "All of the devices were shipped to the same distributor (McKesson)."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 9 Aug 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.