Cooper Surgical, Inc.
FDA Regulatory Profile
Cooper Surgical, Inc. appears in FDA public data with 13 recalls, 6 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1009-2013, Class III) was initiated on February 26, 2013. Its most recent 510(k) clearance was granted on January 20, 2026.
Summary
- Total Recalls
- 13
- 510(k) Clearances
- 6
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1009-2013 | Class III | Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm. Milex Part Number: MXPGE2-3/4 A pessary | February 26, 2013 |
| Z-1008-2013 | Class III | Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXPCOND00 A pessa | February 26, 2013 |
| Z-1011-2013 | Class III | Cooper Surgical Cube Pessary 1 5/8"", 41mm. Milex Part Number: MXKPEC04 A pessary is a medical | February 26, 2013 |
| Z-1012-2013 | Class III | Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number: MXKPECH00 A pessar | February 26, 2013 |
| Z-1006-2013 | Class III | Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. Milex Part Number: MXKPCONDS00 A | February 26, 2013 |
| Z-1004-2013 | Class III | Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex Part Number: MXPCON04 | February 26, 2013 |
| Z-1007-2013 | Class III | Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXKPCOND00 A pess | February 26, 2013 |
| Z-1018-2013 | Class II | Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended f | February 26, 2013 |
| Z-1005-2013 | Class III | Cooper Surgical Incontinence Dish w/ Support Pessary #5, 80mm. Milex :Part Number: MXPCONDS05 A | February 26, 2013 |
| Z-1010-2013 | Class III | Cooper Surgical Gellhorn Flexible Pessary 3", 76mm. Milex Part Number: MXPGE3- A pessary is a me | February 26, 2013 |
| Z-1053-2013 | Class II | LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-volt | February 26, 2013 |
| Z-0440-2013 | Class II | Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The intended u | October 31, 2012 |
| Z-0439-2013 | Class II | Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of t | October 31, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253698 | Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pes | January 20, 2026 |
| K091325 | TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS | June 29, 2009 |
| K023382 | COOPERSURGICAL MALLEABLE SYTLET | December 20, 2002 |
| K023383 | COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER | December 13, 2002 |
| K023384 | COOPERSURGICAL TRIAL TRANSFER CATHETER | December 13, 2002 |
| K023379 | COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER | December 11, 2002 |