Home › Device types › HHW
Pessary, Vaginal
FDA product code HHW · Class 2 · Obstetrics/Gynecology
2,765
Registered devices
575
Adverse events
17
Recalls
41
510(k) clearances
Devices with this code
HNM Women Care — HNM STAINLESS, LLC.NA — PANPAC MEDICAL CORPORATIONNA — PANPAC MEDICAL CORPORATIONMedGyn Pessary Cube w/drain # 5 — MEDGYN PRODUCTS, INC.NA — PANPAC MEDICAL CORPORATIONMarina Medical — MARINA MEDICAL INSTRUMENTS, INC.Bioteque America, Inc. — Bioteque America, Inc.Poise — KIMBERLY-CLARK GLOBAL SALES, INC.MILEX — Coopersurgical, Inc.Milex — Coopersurgical, Inc.NA — PANPAC MEDICAL CORPORATIONHNM Women Care — HNM STAINLESS, LLC.MILEX — Coopersurgical, Inc.NA — PANPAC MEDICAL CORPORATIONHNM Women Care — HNM STAINLESS, LLC.HNM Women Care — HNM STAINLESS, LLC.NA — PANPAC MEDICAL CORPORATIONMilex — Coopersurgical, Inc.Milex — Coopersurgical, Inc.Integra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONMedGyn Pessary Cup w/support # 6 — MEDGYN PRODUCTS, INC.Hayden Medical — Hayden Medical, Inc.MILEX — Coopersurgical, Inc.NA — PANPAC MEDICAL CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot |
| 2021-01-21 | CooperSurgical, Inc. | The affected Milex Gellhorn pessaries were incorrectly manufactured with a long stem (2.170 ), instead of a short stem (1.670 or 1.960 nominal height) as requ |
| 2019-05-02 | Rinovum Women's Health | The product is unable to meet the use life of 31 cycles and may split or crack at the base of the "petals" after repeated use but within the use life of the pro |
| 2017-04-10 | CooperSurgical, Inc. | 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 co |
| 2015-09-14 | CooperSurgical, Inc. | The products have been identified to have incorrect size prints on the MILEX PESSARY KIT packaging. While the Pessary pouch is marked with correct size, an inco |
| 2015-02-09 | CooperSurgical, Inc. | Incorrect size printed on the Milex Pessary Kit packaging label |
| 2014-09-30 | CooperSurgical, Inc. | Incorrect expiration date printed on the MILEX PESSARY KIT packaging |
| 2014-09-30 | CooperSurgical, Inc. | Incorrect expiration date printed on the MILEX PESSARY KIT packaging |
| 2013-02-26 | Cooper Surgical, Inc. | Pessary mislabeled outer package may not reflect the size of the product contained in the package |
| 2013-02-26 | Cooper Surgical, Inc. | Pessary mislabeled outer package may not reflect the size of the product contained in the package |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.