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Lower risk Medical device recall · FDA · Published February 20, 2023

Mani Trocar Kit MTK23S/MTK25S: Packaging Defect May Compromise Sterile Barrier

Mani recalls two trocar kit models (MTK23S and MTK25S) due to potential packaging defects that could compromise sterile barriers. Affected kits were sold with specific lot numbers and expiration dates.

🇺🇸 FDA recall #Z-1468-2023Medical deviceMani ›
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Recalling firmMani, Inc. - Kiyohara FacilityPark 8-3, Kiyoharakogyodanchi; Kiyoharakogyodanchi; Kiyoharakogyodanchi · Utsunomiya, Japan
✎ GovInfoNow plain-language explainer

What happened, in plain English

Mani is recalling two types of trocar kits (MTK23S and MTK25S) because a packaging defect might compromise the sterile barrier. This could lead to contamination if the kits are used without proper sterility. Read more at govinfonow.com/recall/58869-mani-trocar-kit-mtk23s-mtk25s-packaging-defect-may-compromise-sterile.

Source Summary by GovInfoNow · govinfonow.com/recall/58869-mani-trocar-kit-mtk23s-mtk25s-packaging-defect-may-compromise-sterile · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1468-2023

Cite this page

“Mani Trocar Kit MTK23S/MTK25S: Packaging Defect May Compromise Sterile Barrier.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58869-mani-trocar-kit-mtk23s-mtk25s-packaging-defect-may-compromise-sterile. Based on FDA recall #Z-1468-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1468-2023%22&limit=1).

Why it’s dangerous

The packaging defect could compromise the sterile barrier, potentially allowing contamination of the kits. This might lead to infection if the kits are used without proper sterility.

Who’s affected

Medical professionals who use these trocar kits for procedures are likely affected. The risk is low as the defect is packaging-related and not a direct hazard to users.

How to tell if you have this one

Check for the model numbers MTK23S or MTK25S on the packaging. The kits were sold with specific lot numbers and expiration dates listed in the recall notice.

  • Brand
    Mani
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Packaging

    Inspect the packaging for the model number (MTK23S or MTK25S) and lot number.

Where it went and when

Where it was distributed

Distributed in Missouri.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: yesMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “Distribution in US - 1 consignee in Missouri” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Missouri.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

1. Firm started the recall: Feb 20, 202312. FDA classified it Class II: Apr 26, 202323. Published in FDA’s Enforcement Report: May 3, 202334. FDA terminated the recall: May 19, 2025420232025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

How many kits are in one box?

Three kits are contained in one box, with one sterile kit consisting of three pieces.

What are the lot numbers and expiration dates?

Lot numbers and expiration dates are listed in the recall: MTK23S (Lot V210028903, exp. 2024-03), MTK25S (Lots V210009900, V210006701, V210009101, V220016001 with various expiration dates).

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1468-2023 (February 20, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1468-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA