Z-2498-2020Class II

COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part...

Name: Z-2498-2020 COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part...
Creator: CooperSurgical, Inc.
Published: 2020-06-03
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2020-06-03 / Terminated / root cause: labeling and UDI

FDA source

CooperSurgical, Inc. began a recall of COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176 on 2020-06-03. FDA classified it as Class II and gives the reason as "Mislabeled: Printing on the top web or Tyvek lid of the individual product blister tray indicating that it contains a Pipet Current or Part Number MX140 and the display box indicating the correct Os FinderTM Cervical...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2498-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-03
Posted: 2020-07-04
Terminated: 2021-05-11
Recalling firm: CooperSurgical, Inc.
Product: COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176
Product code: LOB Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
Reason for recall: Mislabeled: Printing on the top web or Tyvek lid of the individual product blister tray indicating that it contains a Pipet Current or Part Number MX140 and the display box indicating the correct Os FinderTM Cervical Dilators, Part Number 1176. The product in the individual product package is the correct Os Finder Cervical Dilator
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Cooper Surgical issued letter dated 6/3/20/20 via Certified Mail stating reason for recall, health risk and action to take: Please discontinue use of and quarantine Products with any packaging irregularities, complete the attached Acknowledgement and Receipt Form, and return it to CooperSurgical. Once we receive the Acknowledgement Form, we will arrange for Product replacements and returns of affected Product. The replacement Products will be charged at the same price as the original order and your account will be credited back once the affected Products are returned to CooperSurgical. 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. CooperSurgical contact:: 203-601-5200 ext. 3300.
Quantity in commerce: 2,250 units (45 boxes of 50)
Distribution: Nationwide
Product codes and lots: Lot 284288 - Expiration date: 02/24/2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2498-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2498-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-04

Product code LOB

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)