Recall Z-1314-2023— Fujifilm Irvine Scientific, Inc.

Name: FDA recall Z-1314-2023
Creator: U.S. Food and Drug Administration
Published: 2023-01-16

Class II · Ongoing

Class II FDA medical device recall by Fujifilm Irvine Scientific, Inc., initiated 2023-01-16. It names one FDA 510(k) clearance: K011938. Product: Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305. Reason: Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products..

Recalling firm: Fujifilm Irvine Scientific, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-01-16
Firm location: Santa Ana, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K011938 — OIL FOR EMBRYO CULTUREIrvine Scientific Sales Co., Inc.·cleared 2001-07-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305

Reason for recall

Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.

Data sourced from openFDA. This site is unofficial and independent of the FDA.