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17G Wallace Dual Lumen Oocyte Recovery Set

Model DNS1733-950 · Coopersurgical, Inc. · DI 00888937020946

MQE — Needle, Assisted Reproduction · Class II · 21 CFR 884.6100

UDILibrary device dossier · generated 2026-09-16 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

24682019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 2/device2022-07: 0 reports for this device; peer average 3/device2022-09: 0 reports for this device; peer average 1/device2023-04: 0 reports for this device; peer average 6/device2023-07: 0 reports for this device; peer average 4.67/device2023-08: 0 reports for this device; peer average 3.33/device2023-10: 0 reports for this device; peer average 5/device2023-12: 0 reports for this device; peer average 4/device2024-08: 0 reports for this device; peer average 4/device2025-05: 0 reports for this device; peer average 8/device2026-06: 0 reports for this device; peer average 2/device091007090407081012080506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0901
2019-1002
2022-0703
2022-0901
2023-0406
2023-0704.67
2023-0803.33
2023-1005
2023-1204
2024-0804
2025-0508
2026-0602
This device (reports/month)Average device in MQE (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Coopersurgical, Inc.

  • Warning Letter 2015-06-09 CooperSurgical, Inc.
  • Warning Letter 2015-06-09 CooperSurgical, Inc.
  • Warning Letter 2013-04-25 Lone Star Medical Products, Inc.
  • Warning Letter 2012-07-11 Leisegang Feinmechanick-Optik GmbH
  • VAI 2024-02-01 CooperSurgical, Inc. · 0 citations
  • NAI 2023-05-16 CooperSurgical, Inc. · 0 citations
  • NAI 2023-05-16 CooperSurgical, Inc. · 0 citations
  • VAI 2023-04-27 Lone Star Medical Products, Inc. · 5 citations
  • NAI 2022-12-15 Leisegang Feinmechanick-Optik GmbH · 0 citations
  • VAI 2021-07-15 CooperSurgical, Inc. · 4 citations
  • VAI 2021-07-15 CooperSurgical, Inc. · 4 citations
  • NAI 2019-08-01 CooperSurgical, Inc. · 2 citations
  • NAI 2018-05-02 Lone Star Medical Products, Inc. · 0 citations
  • NAI 2017-12-07 CooperSurgical, Inc. · 0 citations
  • NAI 2017-12-07 CooperSurgical, Inc. · 0 citations
  • NAI 2017-05-04 Lone Star Medical Products, Inc. · 0 citations
  • NAI 2016-03-31 CooperSurgical, Inc. · 0 citations
  • NAI 2016-03-31 CooperSurgical, Inc. · 0 citations
  • NAI 2015-12-10 Leisegang Feinmechanick-Optik GmbH · 0 citations
  • OAI 2014-12-17 CooperSurgical, Inc. · 8 citations
  • OAI 2014-12-17 CooperSurgical, Inc. · 8 citations
  • NAI 2014-12-01 CooperSurgical, Inc. · 0 citations
  • NAI 2014-12-01 CooperSurgical, Inc. · 0 citations
  • VAI 2014-09-23 Lone Star Medical Products, Inc. · 0 citations