Manufacturer

CooperSurgical, Inc.

84 recalls in our database name CooperSurgical, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 84
Critical: 0
Severe: 4
Most recent: 2025-07-30

Of the 84 recalls from CooperSurgical, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (5%) are Severe.

Which agencies issued them

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.

76–84 of 84

HighFDA (Devices)·Z-1300-2015·2015-03-25
CooperSurgical Recalls MediChoice Infant Heel Warmers for Burn Risk
CooperSurgical is recalling MediChoice Infant Heel Warmers because products without expiration dates have a remote potential for minor burns.
Product
MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid Infant Heel Warmer, Item # 1643069912 Single Use and Disposable. Distributed by: Owens & Minor. To provide gentle heat to increase blood flow and enhance infant blood sample collection
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1301-2015·2015-03-25
CooperSurgical Recalls NovaPlus Infant Heel Warmers Due to Burn Risk
CooperSurgical is recalling NovaPlus infant heel warmers because products without expiration dates may cause minor burns.
Product
NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal Warmer. Item #V6393 Single Use and Disposable To provide gentle heat to increase blood flow and enhance infant blood sample collection
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1239-2015·2015-03-11
CooperSurgical Pessary Kit Recalled for Incorrect Size Labeling
CooperSurgical is recalling 95 units of Pessary Kit-CUBE#2 because the packaging label displays the incorrect size.
Product
CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0488-2015·2014-12-10
CooperSurgical Cannula-Curette Recalled for Incorrect Curette Type
CooperSurgical is recalling 30 units of the Cannula-Curette 12MM (Lot 147234) because the product contains an incorrect curette type.
Product
Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION CANNULA-CURETTE device is used to remove tissue from within the uterine cavity on an outpatient basis. The primary uses for this device are for endometrial sampling especially of those patient
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0484-2015·2014-12-03
CooperSurgical LEEP Loop Electrode Recalled for Outer Box Mislabeling
CooperSurgical is recalling LEEP Radius Loop Electrodes because the outer box is mislabeled with the wrong part number.
Product
CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0207-2015·2014-11-19
CooperSurgical MILEX Pessary Kits Recalled for Incorrect Expiration Date
CooperSurgical is recalling 17 MILEX Pessary Kits because the packaging displays an incorrect expiration date.
Product
CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01 Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used to manage a number of gynecologic issues including pelvic support defects and stress urinary inc
Category
Medical Device
Distribution
13 states
LowFDA (Devices)·Z-0208-2015·2014-11-19
CooperSurgical MILEX Pessary Kits Recalled for Incorrect Expiration Date
CooperSurgical is recalling 6 units of MILEX Pessary Kits due to incorrect expiration dates printed on the packaging.
Product
CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Model: MXKPHS01 Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used to manage a number of gynecologic issues including pelvic support defects and stress urinary
Category
Medical Device
Distribution
13 states
ModerateFDA (Devices)·Z-2570-2014·2014-09-17
CooperSurgical H/S Catheter Recalled Due to Unsealed Pouches
CooperSurgical is recalling 1,400 H/S Catheters intended for hysterosonography because some pouches were unsealed.
Product
CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-1782-2014·2014-06-18
Cooper Surgical Tampa Catheter Recalled for Potential Sterility Compromise
CooperSurgical is recalling 1,180 units of the Tampa Catheter because unsealed pouches may compromise the device's sterility.
Product
Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005
Category
Medical Device
Distribution
Distributed nationwide