CLASS II Device recall · Reported 15 Jul 2020 · FDA Enforcement Report

Os FinderTM Cervical Dilator, Taper: to OD Length: Box recalled

CooperSurgical is recalling Coopersurgical Os FinderTM Cervical Dilator, Taper: to OD Length: Box of 50, distributed nationwide in the US. The recall was initiated on 3 Jun 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 284288 - Expiration date: 02/24/2023

Quantity recalled2,250 units (45 boxes of 50)

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-2498-2020
FDA event ID: 85787
Recalling firm: CooperSurgical, Trumbull, CT
Classification: Class II
Status: Terminated
Recall initiated: 3 Jun 2020
FDA classified: 4 Jul 2020
Reported: 15 Jul 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Surgical Instruments

Timeline

3 Jun 2020	Recall initiated by company
4 Jul 2020	Classified by FDA	+31 days
15 Jul 2020	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176

Where it was distributed

Nationwide

Questions about this recall

Is Os FinderTM Cervical Dilator, Taper: to OD Length: Box of 50 recalled?

Yes. CooperSurgical recalled Os FinderTM Cervical Dilator, Taper: to OD Length: Box of 50 on 3 Jun 2020. The recall is Class II and its status is Terminated. Recall number Z-2498-2020.

Why was it recalled?

Which lots are affected?

Lot 284288 - Expiration date: 02/24/2023

Where was it sold?

Nationwide

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from CooperSurgical

All 84

Reported	Class	Recall	Company	Reason	Where
30 Jul 2025Device	CLASS II	HSG Procedure Tray recalled by CooperSurgical	CooperSurgical	Sterility	Nationwide
30 Jul 2025Device	CLASS II	Endosee System Convenience Kit recalled by CooperSurgical	CooperSurgical	Sterility	Nationwide
30 Jul 2025Device	CLASS II	Endosee System Convenience Kit with IV Tube recalled by CooperSurgical	CooperSurgical	Sterility	Nationwide
25 Dec 2024Device	CLASS II	K-Systems R65 Trolley recalled by CooperSurgical	CooperSurgical	Temperature Abuse	14 states
25 Dec 2024Device	CLASS II	K-Systems T47 Warming Plate recalled by CooperSurgical	CooperSurgical	Temperature Abuse	14 states

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide