Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26881 |
| Brand Name: | Apollo BIB/ORBERA |
| Model: | Model Number: B-40800, Model Number: B-50000, Model Number: B-50012 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Clinical & Regulatory Services Limited 30 Fulford Road Havelock North Hastings 4130 |
| Contact Information: | (06) 844 4490 |
| Manufacturer: | Apollo Endosurgery Inc |
| Issue: | The manufacturer is working with the US FDA to update product labelling. No new risks have been identified but some of the language around precautions and balloon fill techniques has been expanded to encourage physician awareness of known risks. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 12/11/2020 |
