Z-0502-2024Class II

Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or...

Name: Z-0502-2024 Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or...
Creator: CooperSurgical, Inc.
Published: 2022-03-31
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2022-03-31 / Open, Classified / root cause: design

FDA source

CooperSurgical, Inc. began a recall of Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine... on 2022-03-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0502-2024
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-31
Posted: 2023-12-06
Recalling firm: CooperSurgical, Inc.
Product: 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
Product code: LKF Cannula, Manipulator/Injector, Uterine
Reason for recall: 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
Root cause tag: design
FDA root cause: Component design/selection
Action: CooperSurgical issued Urgent Medical Device Safety Notice dated March 22, 2023 via UPS Certified Delivery Mail. Letter states reason for recall, health risk and action to take:Our records indicate that you may have purchased the affected Product from CooperSurgical. Please inspect stock and complete the attached Acknowledgement and Receipt Form. Once completed please return the form to CooperSurgical to acknowledge receipt of the notice. If you do not have affected Product in inventory, please use the same enclosed Form to indicate that and return it to CooperSurgical so that we may document receipt of this Recall Notice. A corrective action has been initiated to ensure this failure does not reoccur. We sincerely apologize for any inconvenience caused by this notice. CooperSurgical is committed to high quality, safe and effective products. Please feel free to reach us at 203-601-5200 ext. 3300 or via email at [email protected].
Quantity in commerce: 73 units
Distribution: Nationwide Foreign: BELGIUM CANADA MALAYSIA NETHERLANDS SPAIN SWEDEN SWITZERLAND
Product codes and lots: UDI-DI: 60888937016408 SN: 312868

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0502-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0502-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-06
Z-0503-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-06
Z-0504-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-06

Product code LKF

K961752Class IIH/s Catheter Set(61-3005, 61-3007, 61-3605, 61-3607)Ackrad Laboratories / cleared 1996-08-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)