Skip to content
Get alerts
GovInfoNow
Unrated Medical device recall · FDA · Published September 8, 2020

CooperSurgical MediCult Vitrification Cooling Media Recall: Label Misprint Risk

CooperSurgical recalls MediCult Vitrification Cooling Media Model 12284001F due to label printing error showing wrong product type. Affected units sold in 2023 with specific lot number.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0100-2021Medical deviceCooperSurgical ›
Take action

Contact the company

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

CooperSurgical is recalling MediCult Vitrification Cooling Media Model 12284001F because the product label shows it contains an Equilibration Medium instead of Vitrification Medium. This labeling error could lead to incorrect use in medical procedures. Read more at govinfonow.com/recall/64367-coopersurgical-medicult-vitrification-cooling-media-recall-label-misprint-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/64367-coopersurgical-medicult-vitrification-cooling-media-recall-label-misprint-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0100-2021

Cite this page

“CooperSurgical MediCult Vitrification Cooling Media Recall: Label Misprint Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64367-coopersurgical-medicult-vitrification-cooling-media-recall-label-misprint-risk. Based on FDA recall #Z-0100-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0100-2021%22&limit=1).

The FDA announced on 2020-09-08 that CooperSurgical, Inc. voluntarily recalled MediCult Vitrification Cooling Media due to labeling discrepancies. The hazard involves Chinese characters on the Tyvek label indicating an Equilibration Medium instead of the Vitrification Medium.

How to tell if you have it

  • Brand: CooperSurgical
  • Product: MediCult Vitrification Cooling Media
  • Model Number: 12284001F
  • Lot Code: 20230080
  • Units Affected: 531 total boxes

The hazard

There is a discrepancy between the printing on the Product Tyvek label of the individual component packaging. The Chinese characters on the label indicates that it contains an Equilibration Medium (P/N: 12220001) rather than the Vitrification Medium (P/N: 12230001) as indicated on the remainder of the label.

Context

GovInfoNow's records show CooperSurgical, Inc. has 37 other recalls on record since 2017-10-06. Other recent recalls include a Neonatal CPAP Replacement Set recalled on 2026-08-11 for loose tubing and an Endosee System Convenience Kit recalled on 2025-06-11 for non-sterile iodine pouches. Similar product recalls include Medline Convenience Kits recalled on 2026-05-28 and Fresenius Medical Care Bicarby Dialysate recalled on 2026-05-07.

How to tell if you have this one

Check for the model number 12284001F on the product packaging. The lot number 20230080 is associated with this specific recall batch.

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

What to do — step by step

  1. Check Product Label

    Verify the model number and lot number on the packaging to confirm if it matches the recalled item.

How this recall unfolded

Recall timeline

FDA terminated this recall 4 months after the firm started it.

1. Firm started the recall: Sep 8, 202012. FDA classified it Class II: Oct 13, 202023. Published in FDA’s Enforcement Report: Oct 21, 202034. FDA terminated the recall: Jan 11, 2021420202021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

Similar recalls

Safeguard US Recalls Battle Bandages and IFAK Kits Due to Infection Risk
Safeguard US Operating LLCMiniMed Flex Insulin Pump Recall: Inaccurate Delivery Risk
Medtronic MiniMed, Inc.Medline Bariatric Rollator Recall: Detaching Wheels Risk
Medline Industries, LPCooperVision Pearle Vision 1 Day Contact Lenses: Incorrect Power Risk
CooperVision, Inc.Tandem t:slim App Recall: Pairing Issue With Abbott Sensors
Tandem Diabetes Care, Inc.

Latest medical device recalls

BMC Medical Co., Ltd. recalls BMC/REACTHEALTH Luna G3 APAP REF LG 3600
BMC Medical Co., Ltd. · July 15, 2026Medtronic MiniMed, Inc. recalls MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Medtr: MiniMed · July 13, 2026INTEGRATED MEDCRAFT LLC recalls Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway
Medcraft · July 7, 2026Pride Mobility Products Corp. recalls Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version:
Quantum Rehab · June 25, 2026ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory
ResMed · June 25, 2026Therabody, Inc recalls Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO
Therabody · June 23, 2026

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-0100-2021 (September 8, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0100-2021 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