Recall events
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Event 88225
Event summary
Timeline bucket December 23, 2020
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording Tenderneeds Fertility LLC
Dossier provenance
Source snapshots represented here
openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Complete imported group
Every recalled product in this event
9 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 9
Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001
Z-2175-2021
Recall number Z-2175-2021
Initiated December 23, 2020
Classification Class II
Status Ongoing
Quantity Unknown
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2175-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15221]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
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.
Code information All lots sold prior to December 9, 2019.
Distribution pattern Worldwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[11401]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 9
Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt
Z-2176-2021
Recall number Z-2176-2021
Initiated December 23, 2020
Classification Class II
Status Ongoing
Quantity Unknown
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2176-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15215]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
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.
Code information All lots sold prior to December 9, 2019.
Distribution pattern Worldwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[13329]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 9
Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU 636391205887
Z-2177-2021
Recall number Z-2177-2021
Initiated December 23, 2020
Classification Class II
Status Ongoing
Quantity Unknown
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2177-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58172]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
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.
Code information All lots sold prior to December 9, 2019.
Distribution pattern Worldwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[12263]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 9
Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW
Z-2178-2021
Recall number Z-2178-2021
Initiated December 23, 2020
Classification Class II
Status Ongoing
Quantity Unknown
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2178-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[52077]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
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.
Code information All lots sold prior to December 9, 2019.
Distribution pattern Worldwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[13333]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 9
2 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 143298592960
Z-2179-2021
Recall number Z-2179-2021
Initiated December 23, 2020
Classification Class II
Status Ongoing
Quantity Unknown
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2179-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58170]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
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.
Code information All lots sold prior to December 9, 2019.
Distribution pattern Worldwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[10977]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 9
TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771
Z-2180-2021
Recall number Z-2180-2021
Initiated December 23, 2020
Classification Class II
Status Ongoing
Quantity Unknown
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2180-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[52072]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
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.
Code information All lots sold prior to December 9, 2019.
Distribution pattern Worldwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[12802]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 9
Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856
Z-2181-2021
Recall number Z-2181-2021
Initiated December 23, 2020
Classification Class II
Status Ongoing
Quantity Unknown
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2181-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21757]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
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.
Code information All lots sold prior to December 9, 2019.
Distribution pattern Worldwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[12261]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 9
Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046
Z-2182-2021
Recall number Z-2182-2021
Initiated December 23, 2020
Classification Class II
Status Ongoing
Quantity Unknown
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2182-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[52073]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
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.
Code information All lots sold prior to December 9, 2019.
Distribution pattern Worldwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[12216]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 9
2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknown
Z-2183-2021
Recall number Z-2183-2021
Initiated December 23, 2020
Classification Class II
Status Ongoing
Quantity Unknown
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2183-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33510]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
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.
Code information All lots sold prior to December 9, 2019.
Distribution pattern Worldwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[13670]
FDA event record
· Exact recall-number query on openFDA
