The Recall Desk

Manufacturer

Tenderneeds Fertility LLC

19 recalls in our database name Tenderneeds Fertility LLC as the manufacturing or recalling firm.

What the numbers show

Total
19
Critical
0
Severe
0
Most recent
2021-08-11

Of the 19 recalls from Tenderneeds Fertility LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–19 of 19

  • HighFDA (Devices)·Z-2180-2021·2021-08-11

    TenderNeeds IUI Fertility Kits Distributed Without FDA Marketing Authorization

    TenderNeeds Fertility PRO IUI home insemination kits were distributed without proper FDA marketing authorization. All lots sold before December 9, 2019, are affected.

    Product
    TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2179-2021·2021-08-11

    Sterile Home Artificial Insemination Kits Recalled for Missing FDA Marketing Authorization

    Tenderneeds Fertility LLC is recalling sterile home artificial insemination semen kits distributed worldwide prior to December 9, 2019, due to lack of required FDA marketing authorization.

    Product
    2 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 143298592960
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2182-2021·2021-08-11

    IntraCervical Insemination Kit Recalled for Lack of FDA Marketing Authorization

    Tenderneeds Fertility LLC recalled its Deluxe IntraCervical Insemination Kit worldwide because the device was distributed without FDA marketing authorization. The device was sold prior to December 9, 2019.

    Product
    Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2178-2021·2021-08-11

    Medical Device Recall: Unauthorized Fertility Insemination Kit

    All lots of the Ultimate Fertility At Home Insemination Kit sold before December 9, 2019 are recalled. The device was distributed without FDA marketing authorization.

    Product
    Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2175-2021·2021-08-11

    Fertility IUI Device Recalled for Missing FDA Marketing Authorization

    Tenderneeds Fertility LLC is recalling the Flex IUI Set with LED Lighted Speculum due to distribution without FDA marketing authorization. All units sold worldwide prior to December 9, 2019 are affected.

    Product
    Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2176-2021·2021-08-11

    Home Artificial Insemination Kit Recalled for Lack of Marketing Authorization

    Tenderneeds Fertility LLC is recalling home artificial insemination kits that were distributed without proper FDA authorization. The device was sold worldwide prior to December 9, 2019.

    Product
    Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2183-2021·2021-08-11

    Artificial insemination kits recalled for lack of FDA authorization

    Tenderneeds Fertility LLC is recalling artificial insemination kits that were distributed without proper FDA marketing authorization. All lots sold before December 9, 2019 are affected.

    Product
    2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknown
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2181-2021·2021-08-11

    Deluxe At-Home ICI Insemination Kit Recalled for Unauthorized Distribution

    Tenderneeds Fertility LLC recalls its Deluxe At-Home ICI Insemination Kit (SKU 636391205856), all lots sold before December 9, 2019, due to distribution without FDA marketing authorization.

    Product
    Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2177-2021·2021-08-11

    FDA Recalls IUI Kit and Metal Speculum for Lacking Marketing Authorization

    Tenderneeds Fertility LLC is recalling the Premium Human IUI Kit and Metal Speculum because it was distributed without required FDA marketing authorization. All products sold before December 9, 2019 are affected.

    Product
    Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU 636391205887
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1361-2021·2021-04-14

    Tenderneeds Fertility Recalls Professional Artificial Intrauterine Insemination Kit

    Tenderneeds Fertility LLC is recalling its Professional Artificial Intrauterine Insemination Kit because it was distributed without proper marketing authorization.

    Product
    Professional Artificial Intrauterine Insemination Kit (SKU 636391205986)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1359-2021·2021-04-14

    Tenderneeds Fertility LLC Recalls Deluxe At Home Artificial Insemination Kit

    Tenderneeds Fertility LLC is recalling the Deluxe At Home Artificial Insemination Kit because it was distributed without proper marketing authorization.

    Product
    Deluxe At Home Artificial Insemination Kit (SKU 636391205832)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1356-2021·2021-04-14

    Tenderneeds Insemination Device Recalled for Lack of Marketing Authorization

    Tenderneeds Fertility LLC is recalling its At Home Semi-Flex/Rigid Insemination Device because it was distributed without proper marketing authorization.

    Product
    At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1362-2021·2021-04-14

    Tenderneeds Fertility Recalls Insemination Kits Lacking Marketing Authorization

    Tenderneeds Fertility LLC is recalling Professional Clinical Artificial Intrauterine Insemination Kits because they were distributed without proper marketing authorization.

    Product
    Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1358-2021·2021-04-14

    Tenderneeds Fertility LLC Recalls Deluxe At Home Pro Series Insemination Kit

    Tenderneeds Fertility LLC is recalling the Deluxe At Home Pro Series Insemination Kit because it was distributed without proper marketing authorization.

    Product
    Deluxe At Home Pro Series Insemination Kit (SKU 644042787958)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1364-2021·2021-04-14

    Tenderneeds Fertility Recalls At-Home Insemination Set for Lack of Authorization

    Tenderneeds Fertility LLC is recalling its Professional At Home Artificial Intrauterine Insemination Set because it was distributed without proper marketing authorization.

    Product
    Professional At Home Artificial Intrauterine Insemination Set (SKU 644042787811)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1357-2021·2021-04-14

    Tenderneeds Fertility Recalls At Home Artificial Intrauterine Insemination Flex Set

    Tenderneeds Fertility LLC is recalling the At Home Artificial Intrauterine Insemination Flex Set because it was distributed without proper marketing authorization.

    Product
    At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1355-2021·2021-04-14

    Tenderneeds Fertility Recalls At Home Artificial Intrauterine Insemination Kits

    Tenderneeds Fertility LLC is recalling At Home Artificial Intrauterine Insemination Kits because they were distributed without proper marketing authorization.

    Product
    At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801)
    Category
    Medical Device
    Distribution
    0 states