CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the l...
FDA Device Recall #Z-2054-2017 — Class II — April 10, 2017
Recall Summary
| Recall Number | Z-2054-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 10, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | CooperSurgical, Inc. |
| Location | Trumbull, CT |
| Product Type | Devices |
| Quantity | 7126 units (total for all products) |
Product Description
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.
Distribution Pattern
Worldwide Distributed - US Nationwide in the states of: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN, KS,KY,LA,MA,MD, ME, MI, MN, MO, MS, MT, NC,ND,NE, N H, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and countries of: AUSTRALI A,BAHAMAS,BRAZIL,CANADA, COLOMBIA, COSTA RICA, DENMARK, ENGLAND, GREECE, GUAM, ISRAEL, LITHUANIA, MALAYSIA, NETHERLANDS, NEW ZEALAND, PANAMA, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, and SWEDEN
Lot / Code Information
142947 142948 142949 146348 153078 153079 157415 160844 166923 166924 166925 178346 178347 178348 182458 185831 185832 185834 185835 185836 211779 219502 139577 141310 142937 146344 150141 153064 153065 157402 160467 162612 166911 178317 183618 183619 185809 185810 185812 185814 211776 212978 218621 218622 135402 141313 142941 144528 153069 153070 157406 157407 160839 166915 166916 166917 178320 178321 178322 178323 185818 185822 185823 185824 201919 212980 215758 121937 142944 144530 153074 157411 160842 178332 178333 178334 178335 182453 185826 185827 218669 139581 139582 139583 142946 144532 146347 153076 153077 157414 178343 178344 182455 182456 182457 200176 212983 215760
Other Recalls from CooperSurgical, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2136-2025 | Class II | Endosee System Convenience Kit. Model Number: E... | Jun 11, 2025 |
| Z-2135-2025 | Class II | HSG Procedure Tray. Model Number: 6050T. Th... | Jun 11, 2025 |
| Z-2137-2025 | Class II | Endosee System Convenience Kit with IV Tube. Mo... | Jun 11, 2025 |
| Z-0687-2025 | Class II | Brand Name: K-Systems Product Name: G73 Dry Ba... | Nov 15, 2024 |
| Z-0688-2025 | Class II | Brand Name: K-Systems Product Name: G85 Mini I... | Nov 15, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.