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K-Systems K22074Recalls & reported problems

Coopersurgical, Inc. · G85 Mini Incubator · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888937025057), received between May 24, 2023 and May 24, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Nov 15, 2024Open, Classified

    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.

    Z-0688-2025 · Root cause: Process change control · FDA record ↗

Most reported problems

Device problems

  • Material Rupture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 24, 2023Material Rupture; Material Rupture

    IN AN ATTEMPT TO GET THE GAS FLOW RUNNING, PURGE WAS PRESSED, AND THE BOTTLE LID BLEW OFF. THE REGULATOR WAS AT OVER 1 BAR, WHEREAS THE MANUAL STATES IT SHOULD BE LESS THAN 0.5 BAR. THEN, WHILE REMOVING THE INLET TUBE, THE WELDED BOTTLE JOIN BROKE OFF. 1216677-2023-00086 G85 MINI INCUBATOR K22074 (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16991858 ↗

Other Accessory, Assisted Reproduction, Exempt devices

All Accessory, Assisted Reproduction, Exempt devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.