Device recall: Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001
Class II FDA enforcement event 88225. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Tenderneeds Fertility LLC started this device recall on 23 Dec 2020. The firm address in the FDA record is in Greenville, IN. FDA put the recall in Class II. FDA event 88225 has 9 product records. The first FDA enforcement report date is 11 Aug 2021. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution.
Recalling firm
Tenderneeds Fertility LLC, Greenville, IN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
9 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2175-2021 | Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001 | Unknown | Class II | Ongoing | 11 Aug 2021 |
| Z-2176-2021 | Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt | Unknown | Class II | Ongoing | 11 Aug 2021 |
| Z-2177-2021 | Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU 636391205887 | Unknown | Class II | Ongoing | 11 Aug 2021 |
| Z-2178-2021 | Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW | Unknown | Class II | Ongoing | 11 Aug 2021 |
| Z-2179-2021 | 2 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 143298592960 | Unknown | Class II | Ongoing | 11 Aug 2021 |
| Z-2180-2021 | TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771 | Unknown | Class II | Ongoing | 11 Aug 2021 |
| Z-2181-2021 | Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856 | Unknown | Class II | Ongoing | 11 Aug 2021 |
| Z-2182-2021 | Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046 | Unknown | Class II | Ongoing | 11 Aug 2021 |
| Z-2183-2021 | 2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknown | Unknown | Class II | Ongoing | 11 Aug 2021 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2020
- 916
- Share of these events in Class II
- 93%
- Product records in this event
- 9Median of the firm: 10
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 23 Dec 2020 | At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 6363912058 | Device | Class II | 10 |
Official channels
- FDA enforcement report Z-2175-2021The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 88225. https://recallregister.com/fda/ii/88225/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution.
- What quantity of product is in FDA event 88225?
- The event has 9 product records. The first record gives this quantity:
Unknown
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2020 have the same class?
- 93% of the 916 device events that started in 2020 are in Class II.