The Recall Desk

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.

51–75 of 84

  • SevereFDA (Devices)·Z-1978-2019·2019-07-24

    CooperSurgical Recalls Advincula Delineator Uterine Manipulator Due to Potential Cracking

    CooperSurgical is recalling 213 units of the Advincula Delineator Uterine Manipulator because the soft cup may crack during use, posing a risk of lacerations.

    Product
    Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm; Part No. AD750SC-KE30 The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH)
    Category
    Medical Device
    Distribution
    14 states
  • SevereFDA (Devices)·Z-1977-2019·2019-07-24

    FDA Recalls Advincula Delineator Uterine Manipulator Due to Cracking Risk

    CooperSurgical is recalling 213 units of the Advincula Delineator Uterine Manipulator because the soft cup may crack during use, posing a risk of lacerations.

    Product
    Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH)
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1840-2019·2019-06-26

    LEEP Precision Integrated System Recalled for Incorrect Fuse Installation

    CooperSurgical is recalling 19 LEEP Precision Integrated Systems because incorrect fuses may have been installed in the generator.

    Product
    LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION Cart, LEEP PRECISION Generator, and the LEEP PRECISION Smoke Evacuator for loop electrosurgical excision procedures. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1367-2019·2019-05-29

    CooperSurgical Recalls ICSI Micropipettes Due to Missing Bend

    CooperSurgical is recalling 480 ICSI Micropipettes because the required thirty-degree bend is absent. The affected units were distributed in Denmark, Italy, and Sweden.

    Product
    ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3278-2018·2018-10-03

    CooperSurgical Retractor System Elastic Stays Recalled for Potential Seal Compromise

    CooperSurgical is recalling 18,000 units of Retractor System Elastic Stays because the sterile pouch seal may be compromised, increasing the risk of infection.

    Product
    Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing retraction to achieve and maintain optimal visualization throughout a variety o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1584-2018·2018-05-09

    CooperSurgical Recalls 5 mm Apple-Hunt Secondary Cannulas Due to Packaging Error

    CooperSurgical, Inc. is recalling 520 units of 5 mm Apple-Hunt Secondary Cannulas because they were packaged with the wrong trocar length type.

    Product
    5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count); Model Number 900-840 Product Usage: The Apple-Hunt Secondary Cannulas are indicated for use in laparoscopic surgical procedures to provide a pathway for the introduction of endoscopic surgical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1131-2018·2018-03-28

    CooperSurgical 2 MHz Waterproof OB Probe Recalled for Mislabeling

    CooperSurgical is recalling 13 units of 2 MHz Waterproof OB probes because they were incorrectly labeled as 3 MHz probes.

    Product
    Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and department for late term obstetrical examination associated with larger women. The product detects fetal heart beats as an aid for determinin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2054-2017·2017-05-17

    CooperSurgical lnflatoball Pessary Recalled for Incorrect Latex-Free Labeling

    CooperSurgical is recalling lnflatoball Latex Rubber Pessaries because the secondary packaging incorrectly states the product is latex-free, despite being made of 100% latex.

    Product
    CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit. Product Usage: The lnflatoball Pessary is a single-patient use pessary manufactured from natural latex rubber and is used for treating cystocele and/or rec
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2850-2016·2016-09-28

    Sage CSC Freezing Medium Recalled for Incorrect USA Package Insert

    CooperSurgical is recalling Sage CSC Freezing Medium because it shipped with an international package insert instead of the correct USA version.

    Product
    Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017 SAGE In Vitro Fertilization, Inc. A CooperSurgical Company 95 Corporate Drive Trumbull, CT 06611 USA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2851-2016·2016-09-28

    CooperSurgical Recalls Sage CSC Thawing Medium Due to Incorrect Package Insert

    CooperSurgical, Inc. is recalling 4 units of Sage CSC Thawing Medium because the products contain an international package insert instead of the correct USA package insert.

    Product
    Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number: ART-8018 Intended for use in freezing embryos. This product is intended for thawing of embryos frozen with ART-8017, CSC Freezing Medium. This kit is designed to be used in c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1054-2016·2016-03-16

    CooperSurgical Recalls Milex Arcing Diaphragms Due to Incorrect Size

    CooperSurgical, Inc. is recalling two units of Milex Arcing Diaphragms (Model MXWS95) because they contain an incorrect size diaphragm.

    Product
    Milex Arcing Diaphragm Size 95; Model Number: MXWS95
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-0253-2016·2015-11-18

    CooperSurgical Recalls MILEX Pessary Kits Due to Incorrect Packaging Labels

    CooperSurgical is recalling 144 MILEX Pessary Kits because the outer packaging displays incorrect size prints, although the pessary pouch itself is correctly marked.

    Product
    MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 Product Usage: The Coopersurgical MILEX SILICONE PESSARY is used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0105-2016·2015-10-14

    CooperSurgical LEEP REDIKIT Recalled for Incorrect Lidocaine Concentration Labeling

    CooperSurgical is recalling LEEP REDIKIT surgical kits because the labels list 2% Lidocaine HCl, but the kits contain 1% Lidocaine HCl vials.

    Product
    CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-2098-2015·2015-07-29

    CooperSurgical Recalls Milex Vaginal-Hymenal Silicone Dilators Due to Labeling Error

    CooperSurgical is recalling 40 kits of Milex Vaginal-Hymenal Silicone Dilators because the outer carton labels contain an incorrect expiration date.

    Product
    Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex Vaginal-Hymenal Silicone Dilators are used for progressive vaginal dilation therapy involving the treatment of vaginismus (muscular spasm of the vagina) and conditions that re
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2147-2015·2015-07-29

    CooperSurgical Recalls Infant Heel Warmers for Lack of FDA Clearance

    CooperSurgical is recalling infant heel warmers sold under CooperSurgical and Fisher brands because they were marketed without FDA 510(k) clearance.

    Product
    Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : CooperSurgical PN 20418 WARMGEL INFANT HEEL WARMER - PRISM BOX OF 100; PN 24401 LIQUID INFANT HEEL WARMER - PRISM BOX OF 100; and Fisher Brand. PN 24647 FISHER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1824-2015·2015-07-01

    CooperSurgical Recalls Vaginal Speculums Due to Incorrect Packaging

    CooperSurgical is recalling 9,400 McKesson Medi-Pak Vaginal Speculums because small-sized speculums were incorrectly packaged in bags labeled for medium-sized speculums.

    Product
    McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1814-2015·2015-06-24

    CooperSurgical Recalls MILEX OMNIFLEX Diaphragms Due to Packaging Error

    CooperSurgical is recalling 200 units of MILEX OMNIFLEX Diaphragms because size 80 boxes were incorrectly packaged with size 85 diaphragms.

    Product
    MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1727-2015·2015-06-17

    CooperSurgical Ally Uterine Positioning System Recalled for Injury Risk

    CooperSurgical is recalling five Ally Uterine Positioning System units because the design may expose users to injury to fingers or body parts.

    Product
    Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine manipulators during gynecological laproscopic procedures Model: Ally UPS
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Devices)·Z-1630-2015·2015-05-27

    CooperSurgical Recalls Carter-Thomason II Port Closure System Due to Printing Defect

    CooperSurgical is recalling 430 units of the Carter-Thomason II Port Closure System because pad printing on the suture guide may flake off.

    Product
    Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1450-2015·2015-04-22

    CooperSurgical Recalls Wallach LL 100 Cryosurgical Units Due to Gas Line Burst Risk

    CooperSurgical is recalling 255 Wallach LL 100 cryosurgical units because an internal gas line may malfunction and burst under pressure.

    Product
    WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1397-2015·2015-04-15

    CooperSurgical Infant Transport Mattress Recalled for Missing Expiration Date

    CooperSurgical is recalling TransWarmer Infant Transport Mattresses because they lack expiration dates, potentially failing to meet specifications.

    Product
    CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421 Private label: NovaPlus TransWarmer Infant Heat Therapy Mattress with WarmGel. P/N V6390 Provides warmth during transport of infant within the hospital or between hospitals
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1299-2015·2015-03-25

    Fisher Brand Infant Heel Warmers Recalled for Burn Risk

    CooperSurgical is recalling Fisher Brand Gel and Liquid Infant Heel Warmers because products without expiration dates pose a remote potential for minor burns.

    Product
    Fisher Brand Gel Infant Heel Gel Warmers, Cat. No.: 22-024647 Fisher Brand Liquid Infant Heel Warmer, Cat. No: 22-024646 To provide gentle heat to increase blood flow and enhance infant blood sample collection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1298-2015·2015-03-25

    CooperSurgical Infant Heel Gel Warmers Recalled for Burn Risk

    CooperSurgical is recalling Infant Heel Gel Warmers and The Infant Heel Warmer because products without expiration dates have a remote potential for minor burns.

    Product
    CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P/N 2440 To provide gentle heat to increase blood flow and enhance infant blood sample collection
    Category
    Medical Device
    Distribution
    Distributed nationwide