Lower riskMedical device recall · FDA · Published July 31, 2024
CooperSurgical Stainless Steel Sims Uterine Sound Recalled for Incorrect Part Number
CooperSurgical recalls stainless steel Sims Uterine Sound (part 64-6:601) due to incorrect laser marking during manufacturing. Affected units may have wrong part numbers and should be checked.
“CooperSurgical Stainless Steel Sims Uterine Sound Recalled for Incorrect Part Number.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54376-coopersurgical-stainless-steel-sims-uterine-sound-recalled-for-incorrect-part. Based on FDA recall #Z-3189-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3189-2024%22&limit=1).
CooperSurgical, Inc. recalled Stainless Steel Sims Uterine Sounds with part number 64-601 due to incorrect laser marking of the part number during manufacturing, the FDA said on July 31, 2024.
How to tell if you have it
Brand: CooperSurgical
Product: Stainless Steel Sims Uterine Sound
Part Number: 64-601
UDI-DI: 00888937017779
Part Numbers: 64-600
Quantity: 657 units
The hazard
The devices were laser-marked with the incorrect part number during the manufacturing process, according to the FDA.
Context
GovInfoNow's records show CooperSurgical, Inc. has 37 other recalls on record since Oct. 6, 2017. Other recent recalls of similar products include INCA Infant Nasal CPAP (Aug. 11, 2026), Endosee System Convenience Kit with IV Tube (June 11, 2025), and K-Systems R65 Trolley (Nov. 15, 2024).
How to tell if you have this one
Check for the part number 64-601 on the device. The UDI-DI code 00888937017779 is also associated with this model. This product was sold with part numbers 64-600 and 64-601.
Brand
CooperSurgical
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain, Canada, Hong Kong, India, New Zealand, Qatar, Sweden.
Recall number
Product, codes & lots
Quantity
Z-3188-2024
Silver-Plated Copper Sims Uterine Sound, Part Number 64-600; UDI-DI: 00888937017762; Part Numbers: 64-600
468 units
Z-3189-2024
Stainless Steel Sims Uterine Sound, Part Number 64-601; UDI-DI: 00888937017779; Part Numbers: 64-600
657 units
Based on the official FDA remedy
What to do — step by step
Check Part Number
Verify the part number on the device; affected units have part number 64-601.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain, Canada, Hong Kong, India, New Zealand, Qatar, Sweden.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-3189-2024 (July 31, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3189-2024 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.