Lower risk Medical device recall · FDA · Published June 30, 2021

CooperSurgical Oxygen Sensor Model K54019-2 Recall: Inaccurate Readings May Cause Embryo

CooperSurgical recalls Oxygen Sensor Model K54019-2 used in G185 & G210 Incubators and G603 Work Chambers. Sensors may display incorrect oxygen levels, risking embryo loss during storage.

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

🇺🇸 FDA recall #Z-2307-2021Medical device CooperSurgical ›

Lower-risk recall

Units are displaying output readings that differ from the measurements taken using a Gas Analyzer. When the display is reading a target setting of 5%, an external meter is reading between 3% and 12% and the Incubator does not alarm. May result in loss of embryo during storage.

Take action

Contact the company

Recalling firmCooperSurgical, Inc.95 Corporate Dr · Trumbull, CT 06611-1350

✎ GovInfoNow plain-language explainer

CooperSurgical is recalling Oxygen Sensor Model K54019-2 used in certain incubators and work chambers. These sensors may show inaccurate oxygen readings, which could lead to embryo loss during storage if not corrected. Read more at govinfonow.com/recall/62271-coopersurgical-oxygen-sensor-model-k54019-2-recall-inaccurate-readings-may.

Source Summary by GovInfoNow · govinfonow.com/recall/62271-coopersurgical-oxygen-sensor-model-k54019-2-recall-inaccurate-readings-may · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2307-2021

Cite this page

“CooperSurgical Oxygen Sensor Model K54019-2 Recall: Inaccurate Readings May Cause Embryo.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62271-coopersurgical-oxygen-sensor-model-k54019-2-recall-inaccurate-readings-may. Based on FDA recall #Z-2307-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2307-2021%22&limit=1).

CooperSurgical, Inc. recalled Oxygen Sensor Model K54019-2 used in G185 and G210 Incubators and G603 Work Chambers due to inaccurate oxygen readings that may result in embryo loss. The Food and Drug Administration announced the Class II recall on June 30, 2021.

How to tell if you have it

Brand: CooperSurgical
Model: Oxygen Sensor Model K54019-2
Compatible Products: G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, G603 Work Chamber 230V
CooperSurgical Part Numbers: K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, 3.641.832.153
Serial Numbers: 531540 through 531749, 532001 through 532152, 540659 through 540747, 560830 through 561040, 582528, 582531, 582533, 582534
Units Affected: 421

The hazard

The oxygen sensors display output readings that differ from measurements taken using a Gas Analyzer. When the display reads a target setting of 5%, an external meter may read between 3% and 12%, and the incubator does not alarm, which may result in loss of embryo during storage.

Context

GovInfoNow's records show CooperSurgical, Inc. has issued 37 other recalls since October 6, 2017. Recent brand recalls include an Infant Nasal CPAP set on August 11, 2026, and non-sterile iodine pouches in Endosee System Kits on June 11, 2025. Other recent recalls of similar products include the NOxBOXi Nitric Oxide Delivery System (September 14, 2026) and the Baxter Blue Ventilator Adapter Module (February 18, 2026).

How to tell if you have this one

Check if your incubator or work chamber has the Oxygen Sensor Model K54019-2. Look for the serial numbers listed in the recall (e.g., 531540-531700, 532001, etc.) or part numbers like K22400-110, K59500, etc.

Brand
CooperSurgical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Sensor Serial Numbers
Identify if your incubator or work chamber has the listed serial numbers (e.g., 531540-531700, 532001, etc.) or part numbers like K22400-110, K59500.

How this recall unfolded

Recall timeline

FDA terminated this recall 17 months after the firm started it.

Jun 30, 2021Firm started the recall
Aug 16, 2021FDA classified it Class II
Aug 25, 2021Published in FDA’s Enforcement Report
Nov 21, 2022FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/62271-coopersurgical-oxygen-sensor-model-k54019-2-recall-inaccurate-readings-may">CooperSurgical Oxygen Sensor Model K54019-2 Recall: Inaccurate Readings May Cause Embryo (GovInfoNow)</a>

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-2307-2021 (June 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2307-2021 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.