FDA Device recall Z-1009-2013
Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm
- 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 -2 3/4", 70mm 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-1009-2013 |
| 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 -2 3/4", 70mm. Milex Part Number: MXPGE2-3/4 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:117560 |
|---|
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-1009-2013%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.