Coopersurgical, Inc.
1700 adverse events · 183 recalls · 71 clearances · 34 inspections · 4 compliance actions · aggregated across 4 source records
Scorecard
Events per device across the 2,626-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0.033 ▼
87 in the last 12 months
Higher volume than 90% of companies with 10+ devices
Recalls per device
0 →
0 in the last 12 months
Higher volume than 97% of companies with 10+ devices
These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.
Devices
2,626 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| LEEP PRECISION™ Generator | LP-20-120 | HGI | 00888937014235 | 245 |
| INSORB | 2030 | GDW QQS | 00867516000104 | 137 |
| WALLACH Cryosurgical Equipment | 900076 | GEH | 00888937010961 | 118 |
| Wallach LL100 | 900001 | GEH | 60888937010079 | 114 |
| Wallach Ultra Freeze | 900092 | GEH | 00888937009774 | 95 |
| NEO-fit | 42-2540 | JAY | 00888937016659 | 94 |
| LEEP PRECISION™ Integrated System | LP-10-120 | HGI | 00888937014228 | 67 |
| Mara | DDK-16-050 | MNB | 00888937026887 | 61 |
| Mara Console | GEN-16-050 | MNB | 00888937026870 | 54 |
| TRANSWARMER INFANT TRANSPORT MATTRESS | 20421 | IMD | 00888937025767 | 39 |
| Mystic | 10057 | HDB | 00888937003109 | 35 |
| WALLACH | 909075 | HGI | 00888937013993 | 33 |
| LEEP System 1000® Generator | L1000 | HGI | 00888937014457 | 31 |
| MityOne | 10067 | HDB | 00888937003123 | 30 |
| Fischer Cone Biopsy Excisor | 900-151 | HGI | 00888937003710 | 29 |
| Advincula Delineator™ Uterine Manipulator with 3.5 cm Ultem® Koh-Efficient® | AD750-KE35 | HEW | 00888937012750 | 24 |
| RUMI II Koh-Efficient | KC-RUMI-30 | HEW | 00888937015072 | 24 |
| Fischer Cone Biopsy Excisor | 900-152 | HGI | 00888937003727 | 23 |
| RUMI II Reusable Uterine Manipulator Handle | UMH650 | LKF | 00888937015232 | 21 |
| 17G Wallace Single Lumen Oocyte Recovery Set | ONS1733 | MQE | 00888937021073 | 19 |
| RUMI II Koh-Efficient | KC-RUMI-35 | HEW | 00888937015089 | 19 |
| Advincula Delineator™ Uterine Manipulator with 3.0 cm Ultem® Koh-Efficient® | AD750-KE30 | HEW | 00888937012743 | 17 |
| The RUMI System | UMB678 | LKF | 00888937001402 | 17 |
| CooperSurgical® | DP-SDP001 | ITX | 00888937027792 | 15 |
| Wallach | 900629 | GEH | 00888937009866 | 15 |
| Her Option | CU-1 | MNB | 20888937000027 | 14 |
| Her Option | CG-1 | MNB | 00888937000016 | 14 |
| LEISEGANG | 50501 | GEH | 60888937009967 | 14 |
| LEEP PRECISION™ Generator | DMLP-20-120 | HGI | 00888937019926 | 13 |
| Frigitronics | CE-2000 | HQA | 00888937009422 | 12 |
Showing 1–30 of 2,626Next →
Compliance actions
FDA warning letters and enforcement actions (full history).
| Date | Type | Action | Firm |
|---|---|---|---|
| 2015-06-09 | WL | Warning Letter | CooperSurgical, Inc. |
| 2015-06-09 | WL | Warning Letter | CooperSurgical, Inc. |
| 2013-04-25 | WL | Warning Letter | Lone Star Medical Products, Inc. |
| 2012-07-11 | WL | Warning Letter | Leisegang Feinmechanick-Optik GmbH |
Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|---|---|---|---|
| 3014295858 | COOPER MEDICAL, SRL | La Garita Alajuela, CR | — | |
| 1216677 | COOPERSURGICAL, INC. | Trumbull, CT, US | NAI | |
| 3014755376 | CooperSurgical Distribution B.V. | Herten Limburg, NL | — | |
| 3002895220 | HBH MEDIZINTECHNIK GMBH | TUTTLINGEN Baden-Wurttemberg, DE | — | |
| 3002807462 | LEISEGANG FEINMECHANIK-OPTIK GMBH | BERLIN, DE | NAI | |
| 1627186 | Lone Star Medical Products | Stafford, TX, US | VAI |