Skip to content
Lower risk Medical device recall · FDA · Published April 1, 2022

CooperSurgical VitriGuard Cryopreservation Device Recall: Compromised Sterility Risk

CooperSurgical recalls VITRIGUARD carrier clear cryopreservation storage devices with model 43782001 due to potential compromised barrier seals that could introduce contamination.

🇺🇸 FDA recall #Z-1108-2022Medical deviceCooperSurgical ›
Take action

Contact the company

Recalling firmCooperSurgical, Inc.95 Corporate Dr · Trumbull, CT 06611-1350
✎ GovInfoNow plain-language explainer

CooperSurgical is recalling VITRIGUARD cryopreservation storage devices with model number 43782001 because they may have faulty barrier seals that could allow contamination. This affects medical devices used for storing biological samples at low temperatures. Read more at govinfonow.com/recall/60857-coopersurgical-vitriguard-cryopreservation-device-recall-compromised-sterility-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/60857-coopersurgical-vitriguard-cryopreservation-device-recall-compromised-sterility-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1108-2022

Cite this page

“CooperSurgical VitriGuard Cryopreservation Device Recall: Compromised Sterility Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60857-coopersurgical-vitriguard-cryopreservation-device-recall-compromised-sterility-risk. Based on FDA recall #Z-1108-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1108-2022%22&limit=1).

The FDA announced on April 1, 2022, that CooperSurgical, Inc. is recalling the VitriGuard device (Model No. 43782001) due to compromised barrier seals that risk sterility. Owners should contact the company for a remedy.

How to tell if you have it

  • Brand: CooperSurgical
  • Product: VITRIGUARD, CARRIER, CLEAR; Model No. 43782001
  • Lot: 264453
  • GTIN for UDI on Pouch: 00888937014792
  • GTIN for UDI on Box: 20888937014796

The hazard

Products in this lot may have compromised barrier seals, introducing a risk to sterility.

Context

GovInfoNow's records show CooperSurgical, Inc. has 37 other recalls on record since October 6, 2017. Other recent recalls of similar products include Boston Scientific Intracept Access Instruments Recall (April 22, 2026), Covidien EndoStitch Polysorb Loading Unit Recall (April 15, 2026), and Medtronic DLP Retrograde Cannula Recall (April 21, 2026).

How to tell if you have this one

Check for the model number 43782001 on the VITRIGUARD carrier clear device. The lot number 264453 is also associated with this recall.

  • Brand
    CooperSurgical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Model

    Look for the model number 43782001 on the VITRIGUARD carrier clear device.

Where it went and when

Where it was distributed

Distributed in 10 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: yesORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: yesMOKentucky: not listedKYWest Virginia: yesWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “Domestic distribution to AZ, CA, FL, IL, MI, MO, NY, OR, TX, and WV. No foreign distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Florida, Illinois, Michigan, Missouri, New York, Oregon, Texas, West Virginia.

Recall timeline

FDA published this recall 54 days after the firm started it.

1. Firm started the recall: Apr 1, 202212. FDA classified it Class II: May 17, 202223. Published in FDA’s Enforcement Report: May 25, 202232022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is this device safe to use?

The recall indicates a potential risk of compromised sterility, so it is not recommended for use until the manufacturer provides a remedy.

Similar recalls

Latest medical device recalls

Keep exploring

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-1108-2022 (April 1, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1108-2022 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA