FDA Devices recall · Reported November 24, 2021
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 oocyte
Due to a component in kit being labeled with the incorrect Expiration Date
Fujifilm Irvine Scientific, Inc. recalled Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification … - a moderate-severity action.
Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification … was recalled by Fujifilm Irvine Scientific, Inc. in November 24, 2021. Reason: Due to a component in kit being labeled with the incorrect Expiration Date. Check the official notice for the remedy. Verify recall #Z-0249-2022 with the FDA Devices before acting.
The recall
Fujifilm Irvine Scientific, Inc. issued this moderate-severity FDA Devices recall-Due to a component in kit being labeled with the incorrect Expiration Date.
- Moderate
- severity level
- 4K units
- affected scope
- Class II
- classification
- November 24, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0249-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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
Reason for recall
Due to a component in kit being labeled with the incorrect Expiration Date
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0249-2022 |
| Date reported | November 24, 2021 |
| Date initiated | September 8, 2021 |
| Recalling firm | Fujifilm Irvine Scientific, Inc. |
| Firm location | Santa Ana, CA |
| Affected scope | 3981 units of Vitrification Freeze Kit 90133-SO210605; 314 kits in U.S. and 3667 OUS |
| 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: Bra… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0249-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
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Similar severity · nearest report date
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Methodology · Corrections · Archive as of August 2026