CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual… — Class II medical device recall Z-2054-2017
Terminated recall by CooperSurgical, Inc., reported 2017-05-17, distributed nationwide. The current secondary packaging, a box, incorrectly states that the product is latex free. The product is made
| Recall number | Z-2054-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2017-04-10 |
| Classified | 2017-05-08 |
| Reported by FDA | 2017-05-17 |
| Terminated | 2017-11-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, BS, CA, CO, CR, DK, GB, GR, IL, LT, MY, NL, NZ, PA, PL, PT, RO, SE |
| Quantity | 7,126 units |
| Reason classes | labeling |
Product
CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit. Product Usage: The lnflatoball Pessary is a single-patient use pessary manufactured from natural latex rubber and is used for treating cystocele and/or rectocele associated with procidentia or prolapse. The inflatoball Pessary contains one (1) Pessary in a double-pocketed sealed clear plastic pouch, one pocket containing the Pessary and one pocket containing the Instructions for Use (IFU).
Reason for recall
The current secondary packaging, 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 Instructions for Use (IFU) correctly states that the pessary is manufactured from latex rubber.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2054-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.