The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1468-2023·Announced 2023-05-03

Mani Trocar Kits Recalled for Packaging Defect Compromising Sterility

Mani Trocar Kits (Models MTK23S and MTK25S) are being recalled due to a packaging defect that may compromise the sterile barrier. The recall affects 45 kits distributed to one consignee in Missouri.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves surgical instruments with a risk-of-harm defect affecting sterility. No illnesses or injuries have been reported. As an FDA Class II recall without reported harm, this meets the criteria for High severity per the rubric.

Plain-English summary

Mani Trocar Kit Models MTK23S and MTK25S are subject to a recall issued by the U.S. Food and Drug Administration. These are sterile surgical kits containing three trocars with valved cannulas and one infusion cannula per kit, used in laparoscopic surgical procedures.

The recall is due to a packaging defect that may compromise the sterile barrier of the product. A total of 45 kits were affected and distributed to one consignee in Missouri.

The recalled lots include: Model MTK23S Lot V210028903 (expiration 2024-03), and Model MTK25S Lots V210009900 (expiration 2023-03), V210006701 (expiration 2023-04), V210009101 (expiration 2023-11), and V220016001 (expiration 2024-11-08).

Affected healthcare facilities should cease use of these kits and contact the manufacturer, Mani Inc., for return and replacement procedures.

The recalled product

Product
Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula.
Manufacturer
Mani, Inc. - Kiyohara Facility
Category
Medical Device — Surgical Instruments
Hazard
Affected units
45

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • UDI-DI: 14546951403956 (Model MTK25S) Mani Trocar Kit: 1) Model MTK23S
  • Lot V210028903 (exp. 2024-03) 2) Model MTK25S
  • Lot V210009900 (exp. 2023-03) 3) Model MTK25S
  • Lot V210006701 (exp. 2023-04) 4) Model MTK25S
  • Lot V210009101 (exp. 2023-11) 5) Model MTK25S
  • Lot V220016001 (exp. 2024-11-08)

Distribution

Distributed in 1 state:

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