Database updated: 3 November 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 29155 |
| Brand Name: | Olympus - Lumen extraction balloon, single-use (Japan) |
| Model: | FG-51D, FG-55D |
| Affected: | 71K, 81K, 91K, 01K, 11K, 72K,82K,92K, 02K,12K,73K,83K,93K,03K,13K,74K,84K,94K,04K,14K,75K, 85K,95K,05K,15K,76K,86K,96K,06K,16K,77K,87K,97K,07K,17K,78K,88K,98K,08K,18K,79K,89K,99K,09K,19K,7XK,8XK,9XK,0XK,1XK,7YK,8YK,9YK,0YK,11H,7ZK,8ZK,9ZK, 0ZK,77H |
| Software version: | |
| Recalling Organisation: | Olympus (NZ) Ltd 15D Paul Matthews Road Albany Auckland |
| Contact Information: | 0508 659 6787 |
| Manufacturer: | Olympus Medical Systems Corporation |
| Issue: | The manufacturer has received complaints that the grasping portion of FG-51D forceps can be difficult to open and close. This may result in the following hazards: · The user notices unusual stiffness during inspection before use. It may cause the prolongation of the procedure. · If the user pushed with extra force, the grasping portion (basket) suddenly extruding beyond the sheath and it pushes the mucosa, which may cause mucosal injury. · Difficult to perform procedure. It may cause the prolongation of the procedure. · Device replacing. It may cause the prolongation of the procedure. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 23/3/2022 |
