Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1355-2021 — At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801)

U.S. FDA — Device Enforcement · United States · 2020-12-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1355-2021
Date of alert
2020-12-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Tenderneeds Fertility LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
636391205825
Reported risk: Device was distributed without a proper marketing authorization.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.