Natura 210-005-152Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00877972005452), received between Mar 25, 2019 and Mar 25, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incomplete or Missing Packaging” (1 report).

15 other recalls cover devices cleared under the same FDA submission (K982472); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2019Incomplete or Missing Packaging; Incomplete or Missing Packaging

  A UNIT OF PRODUCT, 210-005-152 (I9525-A) WAS FOUND TO NOT BE SEALED BY THE MANUFACTURER THUS THE STERILE BARRIER WAS NOT IN TACT WHEN IT REACHED THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8448736 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K982472. One submission often covers many models, so check the product and lot details in each record.

• Z-2272-2020 · Aug 21, 2018 · Open, Classified
  Genicon GENILook Model 200-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle
• Z-2275-2020 · Aug 21, 2018 · Open, Classified
  Genicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Troc
• Z-2274-2020 · Aug 21, 2018 · Open, Classified
  Genicon Natura Model 210-005-151; 5mm diameter, 100mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Troc
• Z-2276-2020 · Aug 21, 2018 · Open, Classified
  Genicon Natura Model 210-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Troc
• Z-2270-2020 · Aug 21, 2018 · Open, Classified
  Genicon GENILook Model 200-105-151, 5mm diameter, 100mm length (one cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handl
• Z-2279-2020 · Aug 21, 2018 · Open, Classified
  Genicon Natura Model 210-005-052, 5mm diameter, 70mm length (two cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Troca
• Z-2268-2020 · Aug 21, 2018 · Open, Classified
  Genicon GENILook Model 200-005-153; 5mm diameter, 100mm length (three cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar han
• Z-2273-2020 · Aug 21, 2018 · Open, Classified
  Genicon Natura Model 210-005-051; 5mm diameter, 70mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Troca
• Z-2266-2020 · Aug 21, 2018 · Open, Classified
  Genicon GENILook Model 200-005-151, 5mm diameter, 100mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Tr
• Z-2277-2020 · Aug 21, 2018 · Open, Classified
  Genicon Natura Model 210-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle wh
• Z-2267-2020 · Aug 21, 2018 · Open, Classified
  Genicon GENILook Model 200-005-152, 5mm diameter, 100mm legnth (2 cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Troc
• Z-2271-2020 · Aug 21, 2018 · Open, Classified
  Genicon GENILook Model 200-105-152, 5mm diameter, 100mm length (2 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle
• Z-2269-2020 · Aug 21, 2018 · Open, Classified
  Genicon GENILook Model 200-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Tr
• Z-2278-2020 · Aug 21, 2018 · Open, Classified
  Genicon GENILook Model 200-105-252, 5mm diameter, 150mm length (2 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle
• Z-0622-2009 · Sep 25, 2008 · Terminated
  Genicon 5mm Pyramidal Trocar, Sterile, Genion 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792, Rx Only. Catalog Numbers: 100-005-001 & 100-005-002. Used for incisions