Cooper Surgical, Inc.

FDA recalling firm · 4 enforcement events · 13 product records · 2012–2013 · CT

Cooper Surgical, Inc. has 4 FDA enforcement events on this register (13 product records) between 2012 and 2013: 4 device; the busiest year was 2013 with 3.

0% of its events are Class I; the most common class is Class II (3). 0 events are listed as ongoing; the recalling firm's address is in CT.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
26 Feb 2013	LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and Xylocaine with Epinephrine contained in the LEEP RediKit are local anaesthetic which the physician may choose from during…	Device	Class II	1	Terminated
26 Feb 2013	Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.	Device	Class II	1	Terminated
26 Feb 2013	Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex Part Number: MXPCON04 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.	Device	Class III	9	Terminated
31 Oct 2012	Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation,…	Device	Class II	2	Terminated

By type and class

Device4

Class II3

Class III1

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Cooper Surgical, Inc. by year initiated.

Questions and answers

How many FDA recalls has Cooper Surgical, Inc. had?

4 enforcement events (13 product records) on this register, 2012–2013: 4 device.

Are any Cooper Surgical, Inc. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Cooper Surgical, Inc. recalls?

3 Class II, 1 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.