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Cooper Surgical Recalls
13 recalls on record · December 5, 2012 to April 10, 2013 · Medical Devices
Recalls by year
12
13
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 10, 2013Medical DevicesFDA
Cooper Surgical, Inc. recalls LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire
Hazard: LEEP RediKit Products (for use in Loop Electrosurgical Excision Procedures) have Xylocaine (Lidocaine) HCL (2%) listed on the tray lid label but this is not included in the contents of the kit, which contained Polocaine (Mepivacaine) HCL (3%) instead (which was not listed on the tray label).
April 3, 2013Medical DevicesFDA
Cooper Surgical, Inc. recalls Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contracept
Hazard: Incorrect size was printed on the outer product packaging.
April 3, 2013Medical DevicesFDA
Cooper Surgical, Inc. recalls Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number: MXKPECH00 A pessary is a medical devic
Hazard: Pessary mislabeled outer package may not reflect the size of the product contained in the package
April 3, 2013Medical DevicesFDA
Cooper Surgical, Inc. recalls Cooper Surgical Cube Pessary 1 5/8"", 41mm. Milex Part Number: MXKPEC04 A pessary is a medical device that is inse
Hazard: Pessary mislabeled outer package may not reflect the size of the product contained in the package
April 3, 2013Medical DevicesFDA
Cooper Surgical, Inc. recalls Cooper Surgical Gellhorn Flexible Pessary 3", 76mm. Milex Part Number: MXPGE3- A pessary is a medical device that is
Hazard: Pessary mislabeled outer package may not reflect the size of the product contained in the package
April 3, 2013Medical DevicesFDA
Cooper Surgical, Inc. recalls Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm. Milex Part Number: MXPGE2-3/4 A pessary is a medical device
Hazard: Pessary mislabeled outer package may not reflect the size of the product contained in the package
April 3, 2013Medical DevicesFDA
Cooper Surgical, Inc. recalls Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXPCOND00 A pessary is a medical devi
Hazard: Pessary mislabeled outer package may not reflect the size of the product contained in the package
April 3, 2013Medical DevicesFDA
Cooper Surgical, Inc. recalls Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXKPCOND00 A pessary is a medical dev
Hazard: Pessary mislabeled outer package may not reflect the size of the product contained in the package
April 3, 2013Medical DevicesFDA
Cooper Surgical, Inc. recalls Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. Milex Part Number: MXKPCONDS00 A pessary is a medical
Hazard: Pessary mislabeled outer package may not reflect the size of the product contained in the package
April 3, 2013Medical DevicesFDA
Cooper Surgical, Inc. recalls Cooper Surgical Incontinence Dish w/ Support Pessary #5, 80mm. Milex :Part Number: MXPCONDS05 A pessary is a medical
Hazard: Pessary mislabeled outer package may not reflect the size of the product contained in the package
April 3, 2013Medical DevicesFDA
Cooper Surgical, Inc. recalls Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex Part Number: MXPCON04 A pessary is a medi
Hazard: Pessary mislabeled outer package may not reflect the size of the product contained in the package
December 5, 2012Medical DevicesFDA
Cooper Surgical, Inc. recalls Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The intended use of the RUMI Arch
Hazard: Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle
December 5, 2012Medical DevicesFDA
Cooper Surgical, Inc. recalls Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch is in a
Hazard: Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle