Browse Device Recalls
11 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 11 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 11 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 and result in potentia... | Class II | Intersurgical Inc |
| 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 and result in potentia... | Class II | Intersurgical Inc |
| 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 | Intersurgical Inc |
| 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 been incorrectly ma... | Class II | Intersurgical Inc |
| 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 gas leakage. | Class II | Intersurgical Inc |
| 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 these cracks could pos... | Class II | Intersurgical Inc |
| 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 these cracks could pos... | Class II | Intersurgical Inc |
| 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 these cracks could pos... | Class II | Intersurgical Inc |
| 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 these cracks could pos... | Class II | Intersurgical Inc |
| 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 pushed up and inadv... | Class II | Intersurgical Inc |
| 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 occlusion when the cuff i... | Class II | Intersurgical Inc |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.