Intersurgical Inc
Complete recall history across all FDA and CPSC categories — 11 total recalls
Intersurgical Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (11)
FDA medical device enforcement actions by Intersurgical Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| Jun 20, 2025 | One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090. | Potential contamination with small burrs, which if detach could be inhaled an... | Class II |
| Jun 20, 2025 | One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080. | Potential contamination with small burrs, which if detach could be inhaled an... | Class II |
| Jun 17, 2025 | i-view video laryngoscope. Model Number: 8008000. The i-view video laryng... | Potential for faulty devices as a result of depleted batteries. | Class I |
| Aug 29, 2022 | Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-... | Printing error on the device, size 3 Solus Standard laryngeal mask airway has... | Class II |
| Nov 11, 2020 | Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001... | The device was assembled with the incorrect exhalation port which can cause g... | Class II |
| Aug 7, 2019 | Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy P... | The port may crack in the swivel elbow where the flip cap is inserted, and th... | Class II |
| Aug 7, 2019 | Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996... | The port may crack in the swivel elbow where the flip cap is inserted, and th... | Class II |
| Aug 7, 2019 | Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898... | The port may crack in the swivel elbow where the flip cap is inserted, and th... | Class II |
| Aug 7, 2019 | Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy P... | The port may crack in the swivel elbow where the flip cap is inserted, and th... | Class II |
| Apr 25, 2018 | Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. ... | When assembling an HME or Filter on this breathing circuit the tubing may be ... | Class II |
| Apr 3, 2017 | Solus Flexible wire-reinforced laryngeal mask airways under the following siz... | A defect in the wire-reinforced tubing may result in a partial of total occlu... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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