Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 22863 |
| Brand Name: | Covidien EEA Hemorrhoid and Prolpase Stapler Set |
| Model: | MEM335 and HEM3348 |
| Affected: | Lot Nos: N7K0692MX, N7L0594MX, N7J1145MX and N7M0837MX, N7M0837MX |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | Covidien LLC |
| Issue: | There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak. This issue was identified during in-process Quality testing at the manufacturing facility. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 3/5/2018 |
