CLASS II ONGOING Device recall · Reported 11 Aug 2021 · FDA Enforcement Report
Deluxe IntraCervical Insemination (ICI) Kit recalled
Tenderneeds Fertility is recalling Deluxe IntraCervical Insemination (ICI) Kit. The recall was initiated on 23 Dec 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-2182-2021
- FDA event ID
- 88225
- Recalling firm
- Tenderneeds Fertility, Greenville, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Dec 2020
- FDA classified
- 2 Aug 2021
- Reported
- 11 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 23 Dec 2020 | Recall initiated by company | |
| 2 Aug 2021 | Classified by FDA | +222 days |
| 11 Aug 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
Product as listed by the FDA
Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046
Where it was distributed
Worldwide distribution.
Questions about this recall
Why was it recalled?
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
Which lots are affected?
All lots sold prior to December 9, 2019.
Where was it sold?
Worldwide distribution.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
8 other products · FDA event 88225More recalls from Tenderneeds Fertility
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 2 X Sterile Human Home Artificial Insemination Semen Kit (Human) recalled | Tenderneeds Fertility | Other | IN |
| Device | CLASS II | PRO IUI Human Artificial Home Insemination Kits recalled | Tenderneeds Fertility | Other | IN |
| Device | CLASS II | 2 Complete ICI Human At Home Donor Artificial Insemination recalled | Tenderneeds Fertility | Other | IN |
| Device | CLASS II | Home Artificial Insemination Kit Human IUI ICI Pregnancy recalled | Tenderneeds Fertility | Other | IN |
| Device | CLASS II | Deluxe At-Home Human Artificial Intracervical recalled | Tenderneeds Fertility | Other | IN |
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| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
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| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
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