Device recall

Z-2175-2021: Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001

FDA device recall · Class II · Tenderneeds Fertility LLC

Key facts

Recall number (Z-number) Z-2175-2021
Recall event 88225
Product Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001
Product code MQF
Recalling firm Tenderneeds Fertility LLC
Recall class Class II
Status Open, Classified
FEI number 3012228225

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)