K-SystemsRecalls & reported problems across all models
Coopersurgical, Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
5 open recalls name at least one K-Systems model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 5
We found 6 models of K-Systems by Coopersurgical, Inc. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between May 24, 2023 and Dec 16, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).
5 FDA recall records name at least one of these models by its device identifier, 5 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
K-Systems recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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-0691-2025 · Root cause: Process change control · Recall details · FDA record ↗
- 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-0690-2025 · Root cause: Process change control · Recall details · FDA record ↗
- 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-0689-2025 · Root cause: Process change control · Recall details · FDA record ↗
- 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 · Recall details · FDA record ↗
- 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-0687-2025 · Root cause: Process change control · Recall details · FDA record ↗
Most reported K-Systems problems
Device problems
- Electrical /Electronic Property Problem1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
K-Systems models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- K-Systems K22074Accessory, Assisted Reproduction, Exempt1 recall1 report
- K-Systems K24012Accessory, Assisted Reproduction, Exempt1 recall0 reports
- K-Systems K22065Accessory, Assisted Reproduction, Exempt1 recall0 reports
- K-Systems K23055Accessory, Assisted Reproduction, Exempt1 recall0 reports
- K-Systems K23054Accessory, Assisted Reproduction, Exempt1 recall0 reports
- K-Systems 6.131.812.121Accessory, Assisted Reproduction, Exempt1 report
Recent K-Systems adverse event reports
The 2 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE WORKSTATION WAS INSTALLED ON (B)(6) 2025. DURING INSTALLATION TEST, THE EQUIPMENT FUNCTIONED PROPERLY. ON (B)(6), THE CUSTOMER CONTACTED THE DISTRIBUTOR BECAUSE THE LEFT WORK AREA STOPPED HEATING AND THAT THERE WAS A BURNING SMELL. UPON INSPECTION, TWO SCREWS ON TWO SOLID-STATE RELAYS WERE LOOSE, WITH ONE OF THEM CAUSING SPARKS AND A BURNING SMELL, DANGEROUSLY CLOSE TO ELECTRICAL WIRING. SERVICE TEAM TIGHTENED THE SCREWS AND UNIT IS FUNCTIONING PROPERLY. NO HARM OR PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION AVAILABLE. (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23816252 ↗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 Coopersurgical, Inc. products
All Coopersurgical, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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