CLASS II ONGOING Device recall · Reported 2 Oct 2024 · FDA Enforcement Report
Stainless Steel Sims Uterine Sound recalled by CooperSurgical
CooperSurgical is recalling Stainless Steel Sims Uterine Sound, distributed nationwide in the US. The recall was initiated on 31 Jul 2024 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-3189-2024
- FDA event ID
- 95232
- Recalling firm
- CooperSurgical, Trumbull, CT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Jul 2024
- FDA classified
- 20 Sep 2024
- Reported
- 2 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 31 Jul 2024 | Recall initiated by company | |
| 20 Sep 2024 | Classified by FDA | +51 days |
| 2 Oct 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
During the manufacturing process the devices were laser-marked with the incorrect part number.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Stainless Steel Sims Uterine Sound, Part Number 64-601
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain, Canada, Hong Kong, India, New Zealand, Qatar, Sweden.
Questions about this recall
Why was it recalled?
During the manufacturing process the devices were laser-marked with the incorrect part number.
Which lots are affected?
UDI-DI: 00888937017779; Part Numbers: 64-600
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain, Canada, Hong Kong, India, New Zealand, Qatar, Sweden.
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.
Other products in this recall event
1 other product · FDA event 95232| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Silver-Plated Copper Sims Uterine Sound recalled by CooperSurgical | CooperSurgical | Other | Nationwide |
More recalls from CooperSurgical
All 86| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS II | HSG Procedure Tray recalled by CooperSurgical | CooperSurgical | Sterility | Nationwide |
| Device | CLASS II | Endosee System Convenience Kit recalled by CooperSurgical | CooperSurgical | Sterility | Nationwide |
| Device | CLASS II | Endosee System Convenience Kit with IV Tube recalled by CooperSurgical | CooperSurgical | Sterility | Nationwide |
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