Recall events
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Event 87581
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
10 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 10
At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801)
Z-1355-2021
Recall number Z-1355-2021
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.
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-1355-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4801]
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.
Distribution pattern World-wide 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[32691]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 10
At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903)
Z-1356-2021
Recall number Z-1356-2021
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.
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-1356-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58259]
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.
Distribution pattern World-wide 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[32683]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 10
At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870)
Z-1357-2021
Recall number Z-1357-2021
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.
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-1357-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33410]
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.
Distribution pattern World-wide 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[34443]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 10
Deluxe At Home Pro Series Insemination Kit (SKU 644042787958)
Z-1358-2021
Recall number Z-1358-2021
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.
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-1358-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[22298]
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.
Distribution pattern World-wide 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[33963]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 10
Deluxe At Home Artificial Insemination Kit (SKU 636391205832)
Z-1359-2021
Recall number Z-1359-2021
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.
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-1359-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33418]
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.
Distribution pattern World-wide 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[34049]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 10
Premium At Home Pro Series Insemination Kit (SKU 644042787927)
Z-1360-2021
Recall number Z-1360-2021
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.
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-1360-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16427]
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.
Distribution pattern World-wide 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[34416]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 10
Professional Artificial Intrauterine Insemination Kit (SKU 636391205986)
Z-1361-2021
Recall number Z-1361-2021
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.
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-1361-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[28442]
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.
Distribution pattern World-wide 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[32137]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 10
Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013)
Z-1362-2021
Recall number Z-1362-2021
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.
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-1362-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[28445]
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.
Distribution pattern World-wide 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[32695]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 10
Pro Series Fertility Device (SKU 644042788139)
Z-1363-2021
Recall number Z-1363-2021
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.
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-1363-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58281]
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.
Distribution pattern World-wide 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[34938]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1364-2021
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.
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-1364-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51727]
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.
Distribution pattern World-wide 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[34462]
FDA event record
· Exact recall-number query on openFDA
