FDA Device recall Z-1010-2013
Cooper Surgical Gellhorn Flexible Pessary 3", 76mm
- FDA Device
- Class III
- terminated
- Published 2013-04-03
On 2013-04-03 the FDA classified a Class III recall of Cooper Surgical Gellhorn Flexible Pessary 3", 76mm by Cooper Surgical, citing pessary mislabeled outer package may not reflect the size of the product contained in the package.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1010-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-02-26 |
| Published | 2013-04-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Cooper Surgical |
| Distribution | US |
Product
Cooper Surgical Gellhorn Flexible Pessary 3", 76mm. Milex Part Number: MXPGE3- A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
Reason
Pessary mislabeled outer package may not reflect the size of the product contained in the package
Identifiers
| code_info | Lot Number:117568 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1010-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.