Product Wiki · Recalls · U.S. FDA — Device Enforcement

Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos — recall Z-0692-2025

U.S. FDA — Device Enforcement · United States · 2024-11-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0692-2025
Date of alert: 2024-11-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: CooperSurgical, Inc.
Product category: device
Product type: Devices

Reported risk: The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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