Fujifilm Vit Kit-Freeze Recall: Incorrect Expiration Date Label
Fujifilm Irvine Scientific recalls Vit Kit-Freeze due to incorrect expiration date labeling on kit components. This affects cryopreservation media for assisted reproductive procedures. Contact for remedy details.
Lower-risk recall
Due to a component in kit being labeled with the incorrect Expiration Date
Contact the company
What happened, in plain English
Fujifilm Irvine Scientific recalls Vit Kit-Freeze, a cryopreservation kit for human oocytes and embryos, because one component has an incorrect expiration date label. This could lead to improper use of the kit if the expiration date is misread, though the risk is low since the kit is for medical procedures. Read more at govinfonow.com/recall/61820-fujifilm-vit-kit-freeze-recall-incorrect-expiration-date-label.
Source Summary by GovInfoNow · govinfonow.com/recall/61820-fujifilm-vit-kit-freeze-recall-incorrect-expiration-date-label · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0249-2022
Cite this page
“Fujifilm Vit Kit-Freeze Recall: Incorrect Expiration Date Label.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61820-fujifilm-vit-kit-freeze-recall-incorrect-expiration-date-label. Based on FDA recall #Z-0249-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0249-2022%22&limit=1).
Why it’s dangerous
The kit contains a component labeled with the wrong expiration date. If the expiration date is misread, it could lead to using the kit after it has expired, potentially causing improper freezing or thawing of embryos or oocytes. However, the risk is low because the kit is used in medical procedures with specific protocols.
Who’s affected
People using Vit Kit-Freeze for assisted reproductive procedures, such as fertility treatments, are most at risk if they rely on the incorrect expiration date label. This affects medical professionals and clinics handling the kit.
How to tell if you have this one
Check for the product name 'Vit Kit-Freeze' with catalog number 90133-SO. The kit includes 9x1 mL of Vitrification Solution and Equilibration Solution. Look for lot numbers starting with 90132210403 or UDI # 00893727002811.
- Brand
Fujifilm Irvine- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide Distribution: U.S. (nationwide) to states of: AL, AK, AZ, CA, CT, DE, FL, ID, IL, IN, ND, NC, NV, NY, NJ, NE, OH, OK, OR, PA, SC, SD, MA, MS, MI, MO, MD, MN, TN, TX, UT, VA, VT, WI, WV and OUS (international) to countries of: Brazil, EU, Canada, India, South Korea, and Singapore.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0248-2022 | Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. This kit is designed for use with CryoTip (Catalog #40709), and Vitrification Thaw Kit (Vit Kit-Thaw) for optimal recovery of specimens. Vitrification Freeze kit (which includes the VS Vitrification Solution) are cryopreservation media intended for use in the vitrification of oocytes (MII) and pronuclear (PN) zygotes, cleavage stage embryos, and blastocyst stage embryos. Catalog numbers: 90133-DCOS Vitrification Freeze kit, contained 9x1 mL. Vitrification solution, VS, Catalog #90132. Product form: Liquid. Equilibration Solution-ES is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 7.5% (v/v) of each DMSO and ethylene glycol and 20% (v/v) Dextran Serum Supplement (DSS). Vitrification Solution-VS is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 15% (v/v) of each DMSO and ethylene glycol, 20% (v/v) DSS and 0.5 M sucrose. DSS is a protein supplement consisting of 50 mg/mL therapeutic grade Human Serum Albumin (HSA) and 20 mg/mL Dextran. DSS is used at 20% (v/v) in Vit Kit-Freeze for a final concentration of 10 mg/mL HSA and 4 mg/mL Dextran. These two solutions are to be used in sequence according to the step-wise microdrop vitrification protocol. Vitrification Solution-VS Aseptically filtered. Test results reported on C of A Vit Kit -Freeze (Vitrification Freeze Kit) with Gentamycin and DSS Contains 9 x 1 mL Equilibration Solution- ES; 9 X 1 mL Vitrification Solution-VS ...90133-DCOS...RX Only...Sterile ...20YY-MM-DD; Catalog number: 90133-DSOC Kit- Vitrification Freeze kit: Which contained VS Vitrification solution, Lot/Unit numbers: 90132210403; UDI # 00893727002811; 9 x1 mL Vitrification Solution, VS, Catalog #0132 and 9x1mL. Equilibration Solution, ES Catalog 90131 | 677 units or kits of 90133-DSOC210605 (9 x 1ml per kit); 595 kits in U.S. and 82 kits OUS |
| Z-0249-2022 | Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. This kit is designed for use with CryoTip (Catalog #40709), and Vitrification Thaw Kit (Vit Kit-Thaw) for optimal recovery of specimens. Vitrification Freeze kit (which includes the VS Vitrification Solution) are cryopreservation media intended for use in the vitrification of oocytes (MII) and pronuclear (PN) zygotes, cleavage stage embryos, and blastocyst stage embryos. Catalog numbers: 90133-SO Vitrification Freeze kit, contained 9x1 mL. Vitrification solution, VS, Catalog #90132. Product form: Liquid. Equilibration Solution-ES is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 7.5% (v/v) of each DMSO and ethylene glycol and 20% (v/v) Dextran Serum Supplement (DSS). Vitrification Solution-VS is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 15% (v/v) of each DMSO and ethylene glycol, 20% (v/v) DSS and 0.5 M sucrose. DSS is a protein supplement consisting of 50 mg/mL therapeutic grade Human Serum Albumin (HSA) and 20 mg/mL Dextran. DSS is used at 20% (v/v) in Vit Kit-Freeze for a final concentration of 10 mg/mL HSA and 4 mg/mL Dextran. These two solutions are to be used in sequence according to the step-wise microdrop vitrification protocol. Vitrification Solution-VS Aseptically filtered. Test results reported on C of A Vit Kit -Freeze (Vitrification Freeze Kit) with Gentamycin and DSS Contains 2 x 1 mL Equilibration Solution- ES; 2 X 1 mL Vitrification Solution-VS ...90133-DCOS...RX Only...Sterile ...20YY-MM-DD; Catalog number: 90133-SO Vitrification Freeze kit Lot/Unit numbers: 90132210403; UDI # 00893727002811 Product code MLQ | 3981 units of Vitrification Freeze Kit 90133-SO210605; 314 kits in U.S. and 3667 OUS |
What to do — step by step
Check Expiration Date Label
Verify the expiration date on the kit's component label to ensure it matches the correct date.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 35 states.
FDA distribution: “Worldwide Distribution: U.S. (nationwide) to states of: AL, AK, AZ, CA, CT, DE, FL, ID, IL, IN, ND, NC, NV, NY, NJ, NE, OH, OK, OR, PA, SC, SD, MA, MS, MI, MO, MD, MN, TN, TX, UT, VA, VT, WI, WV and OUS (international) to countries of:…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, California, Connecticut, Delaware, Florida, Idaho, Illinois, Indiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0249-2022 (September 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0249-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.