Lower riskMedical device recall · FDA · Published November 11, 2020
Intersurgical Smoothbore Breathing System Recall: Gas Leakage Risk
Intersurgical recalls Smoothbore breathing systems with incorrect 22mm exhalation port (model B0062001) due to gas leakage risk during anesthesia. Affected units include lot numbers 4200283 and 4200286.
“Intersurgical Smoothbore Breathing System Recall: Gas Leakage Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63934-intersurgical-smoothbore-breathing-system-recall-gas-leakage-risk. Based on FDA recall #Z-0753-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0753-2021%22&limit=1).
The FDA announced on Nov. 11, 2020, that Intersurgical Inc voluntarily recalled Smoothbore breathing systems with exhalation ports due to gas leakage risks. The agency issued recall number Z-0753-2021 for the Class II device.
How to tell if you have it
Brand: Intersurgical
Product: Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Breathing Systems
Model Number: B0062001
Lot Numbers: 4200283 and 4200286
UDI Codes: (01)00081647202239(10)4200286 and (01)00081647202239(10)4200283
Quantity: 200 devices
The hazard
According to the FDA, the device was assembled with an incorrect exhalation port which can cause gas leakage.
Context
GovInfoNow's records show Intersurgical Inc has issued six other recalls since April 25, 2018. Recent brand recalls include a June 15, 2026 recall for One-Piece Guedel Airways regarding potential occlusion risk and a June 20, 2025 recall for the same product concerning small burrs risk. Other recent recalls of similar products include ConMed AirSeal 12mm Access Port Recall (May 14, 2026), ConMed AirSeal 5mm Access Port Recall (May 14, 2026), and ConMed AirSeal 8mm Access Port Recall (May 14, 2026).
How to tell if you have this one
Check for model number B0062001 and lot numbers 4200283 or 4200286 on the device. The product was sold as a Custom Anasthesia Breathing System for medical use.
Brand
Intersurgical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Details
Verify the model number and lot numbers on the device to confirm if it is affected.
How this recall unfolded
Recall timeline
FDA terminated this recall 21 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0753-2021 (November 11, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0753-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.