Manufacturer

Cooper Surgical, Inc.

13 recalls in our database name Cooper Surgical, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 13
Critical: 0
Severe: 1
Most recent: 2013-04-10

Of the 13 recalls from Cooper Surgical, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (8%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–13 of 13

ModerateFDA (Devices)·Z-1053-2013·2013-04-10
Cooper Surgical Recalls LEEP RediKit Due to Incorrect Anesthetic Labeling
Cooper Surgical is recalling LEEP RediKit products because the tray lid label incorrectly lists Xylocaine, while the kit actually contains Polocaine.
Product
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 anaestheti
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1018-2013·2013-04-03
Cooper Surgical Recalls Omniflex Diaphragms Due to Packaging Labeling Error
Cooper Surgical is recalling 80 Omniflex Diaphragms because the incorrect size was printed on the outer packaging.
Product
Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.
Category
Medical Device
Distribution
15 states
LowFDA (Devices)·Z-1012-2013·2013-04-03
Cooper Surgical Cube Pessary Recalled Due to Mislabeled Outer Packaging
Cooper Surgical is recalling 20 units of Cube Pessaries because the outer packaging may not reflect the actual product size.
Product
Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number: MXKPECH00 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.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1006-2013·2013-04-03
Cooper Surgical Incontinence Dish Pessary Recalled for Mislabeled Outer Packaging
Cooper Surgical is recalling 45 units of Incontinence Dish pessaries because the outer package may not reflect the actual product size.
Product
Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. Milex Part Number: MXKPCONDS00 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.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1008-2013·2013-04-03
Cooper Surgical Incontinence Pessary Recalled for Mislabeled Outer Packaging
Cooper Surgical is recalling 31 units of Incontinence Dish Folding Pessaries because the outer packaging may not reflect the actual product size.
Product
Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXPCOND00 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.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1010-2013·2013-04-03
Cooper Surgical Gellhorn Pessary Recalled for Mislabeled Outer Packaging
Cooper Surgical is recalling Gellhorn Flexible Pessaries because the outer packaging may not accurately reflect the size of the product inside.
Product
Cooper Surgical Gellhorn Flexible Pessary 3", 76mm. Milex Part Number: MXPGE3- 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.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1011-2013·2013-04-03
Cooper Surgical Cube Pessary Recalled for Mislabeled Outer Packaging
Cooper Surgical is recalling 70 units of Cube Pessaries because the outer packaging may not reflect the actual size of the product inside.
Product
Cooper Surgical Cube Pessary 1 5/8"", 41mm. Milex Part Number: MXKPEC04 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.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1007-2013·2013-04-03
Cooper Surgical Incontinence Dish Folding Pessary Mislabeled Size Recall
Cooper Surgical is recalling Incontinence Dish Folding Pessaries because the outer package may not reflect the actual product size.
Product
Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXKPCOND00 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.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1004-2013·2013-04-03
Cooper Surgical Incontinence Ring Pessary Recalled for Mislabeled Outer Packaging
Cooper Surgical is recalling 80 units of Incontinence Ring Flexible Pessaries because the outer packaging may not reflect the actual product size.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1009-2013·2013-04-03
Cooper Surgical Gellhorn Pessary Recalled for Mislabeled Outer Packaging
Cooper Surgical is recalling Gellhorn Flexible Pessaries because the outer packaging may not reflect the actual size of the device inside.
Product
Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm. Milex Part Number: MXPGE2-3/4 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.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1005-2013·2013-04-03
Cooper Surgical Incontinence Dish Pessary Recalled for Mislabeled Outer Packaging
Cooper Surgical is recalling 18 units of Incontinence Dish pessaries because the outer package may not reflect the actual product size.
Product
Cooper Surgical Incontinence Dish w/ Support Pessary #5, 80mm. Milex :Part Number: MXPCONDS05 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.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0439-2013·2012-12-05
Cooper Surgical RUMI Arch Uterine Manipulator Handle Recalled for Steel Rod Protrusion
Cooper Surgical is recalling RUMI Arch handles because excessive pressure may cause an internal steel rod to protrude through the shaft.
Product
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 surg
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0440-2013·2012-12-05
Cooper Surgical Recalls Advincula Arch Uterine Manipulator Handles
Cooper Surgical is recalling Advincula Arch handles because the internal steel rod may protrude through the shaft, posing a risk of injury during surgery.
Product
Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 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
Category
Medical Device
Distribution
Distributed nationwide