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Use caution Medical device recall · FDA · Published October 27, 2020

Mani Infusion Cannula 23G S: Risk of Fluid Leakage During Eye Surgery

Mani recalls 23G S infusion cannulas for eye surgery due to potential fluid leakage and disconnection risks. Affected units have specific lot codes and expiration dates.

🇺🇸 FDA recall #Z-0558-2021Medical 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 its 23G S infusion cannulas used in eye surgery because the Luer connector parts may leak fluid or disconnect unexpectedly. This could lead to complications during delicate ophthalmic procedures. Read more at govinfonow.com/recall/64051-mani-infusion-cannula-23g-s-risk-of-fluid-leakage-during.

Source Summary by GovInfoNow · govinfonow.com/recall/64051-mani-infusion-cannula-23g-s-risk-of-fluid-leakage-during · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0558-2021

Cite this page

“Mani Infusion Cannula 23G S: Risk of Fluid Leakage During Eye Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64051-mani-infusion-cannula-23g-s-risk-of-fluid-leakage-during. Based on FDA recall #Z-0558-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0558-2021%22&limit=1).

Why it’s dangerous

The Luer connector parts are slightly too large or too small, which can cause fluid to leak out or the cannula to disconnect unexpectedly during surgery. This is especially risky in eye surgery where precise fluid control is critical.

Who’s affected

Ophthalmic surgeons and medical staff using the cannulas during eye surgery are most at risk. Patients undergoing procedures with these cannulas could face complications if fluid leaks or disconnects.

How to tell if you have this one

Check for lot codes V180082900 (expires Nov 2020) or V190000100 (expires Dec 2020) on the cannula packaging. These units were sold for ophthalmic surgery use.

  • Brand
    Mani
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    US Nationwide distribution in the state of MO.
Recall numberProduct, codes & lotsQuantity
Z-0557-2021MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S; Lot Codes: V180077300, Exp Date: 2020/10 and V200009500, EXp Date: 2022/036 units (US)
Z-0558-2021MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery Ref: MTC 23S; Lot Codes: V180082900, Exp. Date: 2020/11 and V190000100, Exp Date: 2020/1260 units (US)
Based on the official FDA remedy

What to do — step by step

  1. Check Cannula Lot Code

    Look for lot codes V180082900 or V190000100 on the product packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution in the state of MO.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 9 months after the firm started it.

1. Firm started the recall: Oct 27, 202012. FDA classified it Class II: Dec 10, 202023. Published in FDA’s Enforcement Report: Dec 16, 202034. FDA terminated the recall: Aug 11, 2021420202021
  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.

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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-0558-2021 (October 27, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0558-2021 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