PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit — Class II medical device recall Z-1993-2021
Terminated recall by Smiths Medical ASD Inc., reported 2021-07-07, distributed nationwide. One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may have been in
| Recall number | Z-1993-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2021-05-14 |
| Classified | 2021-07-01 |
| Reported by FDA | 2021-07-07 |
| Terminated | 2023-06-09 |
| Distributed | Nationwide (US) |
| Quantity | 40 units |
| Reason classes | labeling |
| Lot numbers | 4072715 |
| Model numbers | 100/596/090 |
Product
PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance of trained personnel.
Reason for recall
One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may have been incorrectly labeled as a 7.0mm ID kit.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1993-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.