FDA Device Intelligence
HomeDevice types › NLM

Laparoscope, General & Plastic Surgery, Reprocessed

FDA product code NLM · Class 2 · Gastroenterology, Urology

556
Registered devices
468
Adverse events
12
Recalls
23
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2018-06-19Stryker Sustainability SolutionsThrough investigation, it was determined that H12LP Trocars in scope of a previous H12LP recall were distributed to facilities within the distribution chain fol
2016-11-11Stryker Sustainability SolutionsAn increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging or during use.
2015-07-10Stryker Sustainability SolutionsStryker Sustainability Solutions has received reports indicating that devices from one lot (lot# 3574704) were labeled as 100mm models (CB5LT) while the devices
2015-06-01Stryker Sustainability SolutionsStryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragme
2015-06-01Stryker Sustainability SolutionsStryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragme
2015-06-01Stryker Sustainability SolutionsStryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragme
2015-03-20CooperSurgical, Inc.The pad printing around the suture entry holes on the 15mm Suture Guide included in the kit may not have been appropriately manufactured resulting in the pad pr
2013-05-03Surgical Instrument Service And Savings, Inc.The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
2010-07-09Ethicon Endo-Surgery IncThe weld that connects the electrode to the active rod was separated. This connection is critical to the proper function of these devices. If the weld is separa
2008-03-11Ascent Healthcare Solutions, Inc.Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.