Home › Device types › JOH
Tube Tracheostomy And Tube Cuff
FDA product code JOH · Class 2 · Anesthesiology
54,916
Registered devices
14,926
Adverse events
131
Recalls
109
510(k) clearances
Devices with this code
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Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-15 | Covidien LLC | Due to customer complaint regarding incorrect display box labeling. |
| 2026-03-05 | Cook Incorporated | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2026-03-05 | Cook Incorporated | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2026-03-05 | Cook Incorporated | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2026-03-05 | Cook Incorporated | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2025-02-26 | Covidien | Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, |
| 2023-08-22 | Smiths Medical ASD Inc. | The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration dat |
| 2023-04-07 | Cook Incorporated | There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit compone |
| 2023-04-07 | Cook Incorporated | There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit compone |
| 2023-03-24 | Covidien | A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15m |
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