FDA Devices Verify with FDA Devices → Moderate Class II Ongoing

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

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on November 24, 2021. Severity: Moderate. Recall number: Z-0249-2022.

Q: Where was the recalled product distributed?

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..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-0249-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Reviewed byPlainRecalls Editorial, Product Recalls Editorial Team · June 6, 2026

Reported: November 24, 2021 Initiated: September 8, 2021 #Z-0249-2022 3981 units of Vitrification Freeze Kit 90133-SO210605; 314 kits in U.S. and 3667 OUS units

Fujifilm Irvine Scientific, Inc. issued this FDA Devices recall on November 24, 2021. Classified as Moderate severity (Class II). Approximately 3981 units of Vitrification Freeze Kit 90133-SO210605; 314 kits in U.S. and 3667 OUS units are affected. The recall was issued because: Due to a component in kit being labeled with the incorrect Expiration Date. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Devices action (record #Z-0249-2022) was formally reported on November 24, 2021, with the manufacturer initiating the action on September 8, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Fujifilm Irvine Scientific, Inc. is listed as the recalling firm, operating out of Santa Ana, CA. Federal records indicate 3981 units of Vitrification Freeze Kit 90133-SO210605; 314 kits in U.S. and 3667 OUS units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Due to a component in kit being labeled with the incorrect Expiration Date Distribution data in the federal record shows the product reached: 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) …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 5 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity

Moderate

Units Affected

3981 units of Vitrification Freeze Kit 90133-SO210605; 314 kits in U.S. and 3667 OUS

Related Recalls

6 from same agency

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

Details

Recalling Firm: Fujifilm Irvine Scientific, Inc.
Units Affected: 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: Brazil, EU, Canada, India, South Korea, and Singapore.
Location: Santa Ana, CA

Recall Profile

Structured summary of the FDA Devices recall record
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.
Units affected	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.

Scale of Impact

3981 units of Vitrification Freeze Kit 90133-SO210605; 314 kits in U.S. and 3667 OUS units affected — million-unit bracket.

Regional (<10K units) —

Multi-state (10K – 100K units) —

Large-scale (100K – 1M units) —

Massive (≥1M units) ✓ This recall

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Due to a component in kit being labeled with the incorrect Expiration Date

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on November 24, 2021. Severity: Moderate. Recall number: Z-0249-2022.

Where was the recalled product distributed? ▼

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..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-0249-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Related Safety Data

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Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Read our methodology — how this data is sourced, computed, and verified.

All federal data sources used on this page

U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Accessed 2026-06-06 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).