FDA Medical Device Recalls (openFDA)
Fujifilm Irvine Scientific, Inc.: Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
- Recall number
- Z-1314-2023
- Recalling firm
- Fujifilm Irvine Scientific, Inc.
- Product
- Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
- Status
- Open, Classified
- Initiated
- 2023-01-16
- Posted
- 2023-04-01
- Terminated
- not on file
- Reason
- Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.
- Root cause
- Nonconforming Material/Component
- Action
- On 01/16/2023, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that, the firm has received complaints of reduced blastocyst development, including complete degradation in some cases, during culture of human embryos. Additionally, some clinics performed Human Sperm Survival Assay (HSSA), as part of incoming confirmatory Quality Control testing, and reported low sperm motility. Customers are instructed to: 1. Immediately stop using the product; 2. Quarantine any remaining product in inventory; 3. Return or destroy the product; 4. Complete and return the enclosed MEDICAL DEVICE RETURN RESPONSE FORM; and 5. Email the completed MEDICAL DEVICE RETURN RESPONSE FORM to fisira@fujifilm.com by January 23, 2023. For questions, contact: Customer Service Manager, Medical Business: - Toll free in the US: 1.800.577.6097 - Phone: 1.949.261.7800 x457 - Email: Melissa Gomez, fisitmrequest@fujifilm.com
- Quantity
- 15,131 bottles
- Distribution
- U.S.: AZ, AR, CA, CT, DC, FL, HI, IA, ID, IL, IN, KS, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WI and WV. O.U.S.: India, Israel, Japan, Malaysia, Mexico, South Korea, South Africa, Thailand, Vietnam, Brazil, Bosnia, Argentina, Netherlands, and United Kingdom
- Lot, serial or model codes
- UDI-Di Code: 08937270029305TH Catalog Number / Lot Numbers: 9305-100ml / 0000011351, 9305-500ml / 0000011367, 9305-100ml / 0000015999, 9305-500ml / 0000016001
- 510(k) numbers
- K011938
- PMA numbers
- not on file
- Product code
- MQL
- Firm FEI
- 2022379
- Firm city
- Santa Ana
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28