Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 3, 2023
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.
A packaging defect may compromise the sterile barrier.
The recall
Mani, Inc. - Kiyohara Facility issued this moderate-severity FDA Devices recall — A packaging defect may compromise the sterile barrier..
- Moderate
- severity level
- Class II
- classification
- May 3, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1468-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1468-2023) was formally reported on May 3, 2023, with the manufacturer initiating the action on February 20, 2023. It is classified under Moderate severity (Class II), with a current status of Terminated. Mani, Inc. - Kiyohara Facility is listed as the recalling firm, operating out of Utsunomiya, N/A. Federal records list the affected scope as 45 kits.
The documented reason for this recall is: A packaging defect may compromise the sterile barrier. Distribution data in the federal record shows the product reached: Distribution in US - 1 consignee in Missouri. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 27,303 medical devices recalls on record
Where this recall sits in the database
Of 83,949 recalls in the database, 21,198 are high severity, 58,883 moderate, and 3,868 low. This recall is classified moderate severity.
Affected scope
45 kits
Related Recalls
6
6 from same agency
Product description
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.
Reason for recall
A packaging defect may compromise the sterile barrier.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1468-2023 |
| Date reported | May 3, 2023 |
| Date initiated | February 20, 2023 |
| Recalling firm | Mani, Inc. - Kiyohara Facility |
| Firm location | Utsunomiya, N/A |
| Affected scope | 45 kits |
| Distribution | Distribution in US - 1 consignee in Missouri |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Mani, Inc. - Kiyohara Facility. Units affected: 45 kits.
Why was this product recalled? ▼
A packaging defect may compromise the sterile barrier.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 3, 2023. Severity: Moderate. Recall number: Z-1468-2023.
Where was the recalled product distributed? ▼
Distribution: Distribution in US - 1 consignee in Missouri.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1468-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported May 3, 2023.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
Source: Federal recall agencies (FDA, CPSC, NHTSA) Aggregated federal recall feeds Recall data normalized across FDA, CPSC and NHTSA feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type).