Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18521 |
| Brand Name: | Covidien Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, cuffless |
| Model: | Product Numbers: 2.5NEF, 3.0NEF, 3.5NEF, 4.0NEF, 4.5NEF, 2.5PEF, 3.0PEF, 3.5PEF, 4.0PEF, 4.5PEF, 5.0PEF, 5.5PEF, 5.0PELF, 5.5PELF, 6.0PELF, 6.5PELF |
| Affected: | All lot numbers beginning with 12, 13, and 14 |
| Software version: | |
| Recalling Organisation: | Covidien NZ Ltd Level 3, Building 5, Central Park Corporate Centre 666 Great South Road Penrose AUCKLAND 1051 |
| Contact Information: | 0508 489 264 |
| Manufacturer: | Covidien LLC |
| Brand Name: | Covidien Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff |
| Model: | Product Numbers: 2.5NCF, 3.0NCF, 3.5NCF, 4.0NCF, 4.5NCF, 2.5PCF, 3.0PCF, 3.5PCF, 4.0PCF, 4.5PCF, 5.0PCF, 5.5PCF, 5.0PLCF, 5.5PLCF, 6.0PLCF, 6.5PLCF |
| Affected: | All lot numbers beginning with 12, 13, and 14, plus 15A0151JZX to 15AO155JZX |
| Software version: | |
| Recalling Organisation: | Covidien NZ Ltd Level 3, Building 5, Central Park Corporate Centre 666 Great South Road Penrose AUCKLAND 1051 |
| Contact Information: | 0508 489 264 |
| Manufacturer: | Covidien LLC |
| Issue: | Covidien has recalled these devices following reports from customers, where patients who recently switched from the current Shiley™ Neonatal and Pediatric products to the affected products, experienced discomfort immediately after the switch in a limited number of situations. In some cases, breathing difficulties, corresponding to a negative effect on oxygen levels, were also observed immediately after the switch. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 19/5/2015 |
