Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21343 |
| Brand Name: | Cooper Surgical Inflatoball Pessary |
| Model: | CO-MXPINFM and CO-MXPINFL |
| Affected: | LOT NUMBER: 178321 and 185809 |
| Software version: | |
| Recalling Organisation: | Downs Distributors Ltd 9 Airborne Road North Harbour AUCKLAND |
| Contact Information: | 0800 800 234 |
| Manufacturer: | CooperSurgical Inc |
| Issue: | The manufacturer is recalling specific lots of its Inflatoball Pessary and Inflatoball Pessary Kit products. These products are being recalled due to a labelling error on the secondary package. The current secondary package, a box, incorrectly states that the product is latex free. The product is made with 100% latex. The label on the package that contains the product and the IFU correctly states that the pessary is manufactured from latex rubber. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 28/4/2017 |
