CLASS II ONGOING Device recall · Reported 12 Apr 2023 · FDA Enforcement Report
Global Total LP single step medium recalled by CooperSurgical
CooperSurgical is recalling Global Total LP single step medium, bicarbonate-buffered media for D1-5 embryo culture, distributed nationwide in the US. The recall was initiated on 13 Feb 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1348-2023
- FDA event ID
- 91794
- Recalling firm
- CooperSurgical, Trumbull, CT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Feb 2023
- FDA classified
- 6 Apr 2023
- Reported
- 12 Apr 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 13 Feb 2023 | Recall initiated by company | |
| 6 Apr 2023 | Classified by FDA | +52 days |
| 12 Apr 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source required for embryo culture and development.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060
Where it was distributed
Worldwide - US Nationwide distribution in the states of NY, UT and the countries of Argentina, Belgium, Bulgaria, Ecuador, France, Germany, Hong Kong, Italy, Malaysia, Mexico, Peru, Singapore, Spain, Switzerland, Thailand, Turkey, the United Kingdom.
Questions about this recall
Why was it recalled?
It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source required for embryo culture and development.
Which lots are affected?
UDI-DI: 00815965020433; LOT 221118-010694
Where was it sold?
Worldwide - US Nationwide distribution in the states of NY, UT and the countries of Argentina, Belgium, Bulgaria, Ecuador, France, Germany, Hong Kong, Italy, Malaysia, Mexico, Peru, Singapore, Spain, Switzerland, Thailand, Turkey, the United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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