CLASS II Device recall · Reported 16 Dec 2020 · FDA Enforcement Report
Mani Trocar Kit S recalled by Mani, Inc. - Kiyohara Facility
Mani, Inc. - Kiyohara Facility is recalling Mani Trocar Kit S, distributed nationwide in the US. The recall was initiated on 27 Oct 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0557-2021
- FDA event ID
- 86873
- Recalling firm
- Mani, Inc. - Kiyohara Facility, Utsunomiya, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Oct 2020
- FDA classified
- 10 Dec 2020
- Reported
- 16 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Surgical Instruments
Timeline
| 27 Oct 2020 | Recall initiated by company | |
| 10 Dec 2020 | Classified by FDA | +44 days |
| 16 Dec 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S
Where it was distributed
US Nationwide distribution in the state of MO.
Questions about this recall
Is Mani Trocar Kit S recalled?
Yes. Mani, Inc. - Kiyohara Facility recalled Mani Trocar Kit S on 27 Oct 2020. The recall is Class II and its status is Terminated. Recall number Z-0557-2021.
Why was it recalled?
Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use
Which lots are affected?
Lot Codes: V180077300, Exp Date: 2020/10 and V200009500, EXp Date: 2022/03
Where was it sold?
US Nationwide distribution in the state of MO.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mani, Inc. - Kiyohara Facility
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Mani Trocar Kit recalled by Mani, Inc. - Kiyohara Facility | Mani, Inc. - Kiyohara Facility | Sterility | MO |
| Device | CLASS II | MANI Infusion Cannula S recalled by Mani, Inc. - Kiyohara Facility | Mani, Inc. - Kiyohara Facility | Potency & Assay | Nationwide |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |