Use cautionMedical device recall · FDA · Published March 31, 2022
CooperSurgical H/S ELLIPTOSPHERE CATH 5 Fr recall: Catheter may detach during procedure
CooperSurgical recalls H/S ELLIPTOSPHERE CATH : Incorrect bonding material may cause detachment, delaying procedures. Affected units have model 61-3005 and specific serial numbers.
Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure
Take action
Contact the company
📍Recalling firmCooperSurgical, Inc.95 Corporate Dr · Trumbull, CT 06611-1350
“CooperSurgical H/S ELLIPTOSPHERE CATH 5 Fr recall: Catheter may detach during procedure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60860-coopersurgical-h-s-elliptosphere-cath-5-fr-recall-catheter-may. Based on FDA recall #Z-0502-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0502-2024%22&limit=1).
CooperSurgical, Inc. recalled Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr catheters on March 31, 2022, according to the FDA. The devices may fail due to incorrect bonding material, potentially causing component detachment or leakage.
How to tell if you have it
Brand: CooperSurgical
Product: Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr
Model: 61-3005
UDI-DI: 60888937016408
SN: 312868
The hazard
The recall cites incorrect bonding material used for assembly, which may result in detachment of component parts, broken components, or leakage. This breakage may cause a delay in the procedure.
Context
GovInfoNow's records show CooperSurgical, Inc. has issued 37 other recalls since October 6, 2017. Recent similar recalls include the INCA Infant Nasal Cannulae Assy recall on August 11, 2026, and the HSG Procedure Tray Recall on June 11, 2025.
How to tell if you have this one
Check for model number 61-3005 on the catheter. Serial numbers starting with 312868 are affected. These catheters are used for hysterosalpingography procedures.
Brand
CooperSurgical
Category
Medical device
FDA recall event · 3 products
All 3 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
Nationwide Foreign: BELGIUM CANADA MALAYSIA NETHERLANDS SPAIN SWEDEN SWITZERLAND
Recall number
Product, codes & lots
Quantity
Z-0502-2024
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes. Model: 61-3005; UDI-DI: 60888937016408 SN: 312868
73 units
Z-0503-2024
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes Model: 61-4005; UDI-DI:60888937016446 S/N: 313121, 313568
169 units
Z-0504-2024
CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes; UDI-DI: 60888937016453 S/N: 309967
90 units
Based on the official FDA remedy
What to do — step by step
Check Model Number
Look for model number 61-3005 on the catheter.
Contact Manufacturer
Contact CooperSurgical for further instructions if you have the affected model.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Nationwide Foreign: BELGIUM CANADA MALAYSIA NETHERLANDS SPAIN SWEDEN SWITZERLAND” 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 20 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-0502-2024 (March 31, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0502-2024 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.