Food, drugs, devices › CooperSurgical, Inc.

Device recall: CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21

FDA enforcement event 85544 · Class II · initiated 9 Apr 2020 · status Terminated · terminated 11 May 2021

DeviceVoluntary: Firm initiated1 product recordTrumbull, CT

FDA enforcement event 85544 is a device recall by CooperSurgical, Inc. of Trumbull, CT, initiated 9 Apr 2020 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.

Status: Terminated, terminated 11 May 2021. Initiation: voluntary: firm initiated. CooperSurgical, Inc. has 57 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

CooperSurgical, Inc., Trumbull, CT.

Reason for recall

"The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators."

Distribution

"Distribution to North America including the following states: AZ, CA, CT, DC, DE, FL, GA, IA, IN, MA, MI, MN, MO, NC, NH, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-2112-2020	CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21	1740 units/174 boxes	Class II	Terminated	3 Jun 2020

Context

93%of 2020 device events are Class II916 events that year

1product record in this eventfirm median: 1

57events on this register for the firm

Other enforcement events for CooperSurgical, Inc.

Initiated	Product (first record)	Type	Class	Records
11 Jun 2025	HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterograph	Device	Class II	3
15 Nov 2024	Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electric	Device	Class II	6
31 Jul 2024	Silver-Plated Copper Sims Uterine Sound, Part Number 64-600	Device	Class II	2
16 Feb 2024	Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A	Device	Class II	3
20 Dec 2023	global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Cult	Device	Class II	1
29 Aug 2023	Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Re	Device	Class II	1
13 Feb 2023	Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Num	Device	Class II	1
15 Dec 2022	BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantati	Device	Class II	1
20 Oct 2022	NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540	Device	Class II	1
12 Aug 2022	Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Mark I	Device	Class II	2

All 57 events for CooperSurgical, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Distribution to North America including the following states: AZ, CA, CT, DC, DE, FL, GA, IA, IN, MA, MI, MN, MO, NC, NH, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 11 May 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.