CooperSurgical, Inc.
97 recalls on record · Latest: Jul 30, 2025
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Agency notice ledger
Federal filing book CooperSurgical, Inc. MID-BOOK · MULTI-AGENCY
#172 of 14,151 · 97 notices · 0.093% archive
- BOOK 97 notices
- RANK #172 of 14,151
- SHARE 0.093% archive
- AGENCY FDA Devices (96)
- CAT medical devices
- CATS 2 categories
- LATEST Jul 30, 2025
- PHOTO Medtronic Neuromodula…
Nearest notice-volume peer: Medtronic Neuromodulation (1 notice gap)
CooperSurgical, Inc. accounts for about 0.093% of the 104,423-notice archive on 97 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →
Where CooperSurgical, Inc. sits among 14,151 recalling firms
CooperSurgical, Inc. ranks 172nd of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.
CooperSurgical, Inc. vs all firms by recall-notice count
Where this firm's archive sits among every tracked recalling manufacturer
97 172nd of 14151 higher than 13,979 of 14,151 firms
Firms, banded by distinct federal recall-event inventory
Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13
CooperSurgical, Inc. in the notice-volume neighbourhood
Distinct federal recall events among this firm and nearest nationwide peers
- Advanced Phar…
Advanced Pharma Inc.
99 notices
- Angiodynamics…
Angiodynamics, Inc.
99 notices
- Encore Medica…
Encore Medical, LP
99 notices
- Medtronic Neu…
Medtronic Neuromodulation
98 notices
- CooperSurgica… (this)
CooperSurgical, Inc.
97 notices
- Medaus, Inc.
Medaus, Inc.
96 notices
What this shows CooperSurgical, Inc. holds about 0.093% of archive notices alongside 97 distinct filings.
How the 97 notices break down
Same federal filing book as the hero total — split by issuing agency, no new counts.
FDA Devices Moderate Jul 24, 2019
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), and/or Laparoscopic Supra-Cervical Hysterectomy (LSCH).
FDA Devices Moderate Jul 24, 2019
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), and/or Laparoscopic Supra-Cervical Hysterectomy (LSCH).
FDA Devices Moderate Jun 26, 2019
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 loop electrosurgical excision procedure (LEEP) utilizes a very thin wire in the shape of a loop heated by electrical current generated by a power supply to efficiently remove abnormal cells. The LEEP PRECISION INTEGRAT
FDA Devices Moderate May 29, 2019
ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0
FDA Devices Moderate Oct 17, 2018
Colpo-Pneumo Occluder, Part CPO-6
FDA Devices Moderate Oct 3, 2018
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 of procedures.
FDA Devices Moderate May 23, 2018
Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151
FDA Devices Moderate May 9, 2018
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 instruments and allow for maintenance of pneumoperitoneum. For uninhibited laparoscopic access, the Apple-Hunt Cannula/Trocar provides greater instrument maneuverability while maintaining an airtight seal -with no bulky
FDA Devices Moderate Mar 28, 2018
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 determining fetal viability.
FDA Devices Moderate May 17, 2017
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 rectocele associated with procidentia or prolapse. The inflatoball Pessary contains one (1) Pessary in a double-pocketed sealed clear plastic pouch, one pocket containing the Pessary and one pocket containing the Instructio
FDA Devices Low Sep 28, 2016
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
FDA Devices Low Sep 28, 2016
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 conjunction with the SAGE CSC Freezing Medium Kit (ART-8017).
FDA Devices Moderate Mar 16, 2016
Milex Arcing Diaphragm Size 95; Model Number: MXWS95
FDA Devices Low Nov 18, 2015
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.
FDA Devices Low Oct 14, 2015
CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
FDA Devices Moderate Jul 29, 2015
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 result in constriction of the vaginal and/or rectal orifice
FDA Devices Moderate Jul 29, 2015
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 FISHERBRAND GEL INFANT - HEEL WARMER BOX OF 100; PN 24646 FISHERBRAND LIQUID INFANT - HEEL WARMER- 100 PER BOX
FDA Devices Moderate Jul 1, 2015
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
FDA Devices Moderate Jun 24, 2015
MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
FDA Devices Moderate Jun 17, 2015
Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine manipulators during gynecological laproscopic procedures Model: Ally UPS
FDA Devices Moderate May 27, 2015
Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.
FDA Devices Moderate Apr 22, 2015
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
FDA Devices Moderate Apr 15, 2015
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
FDA Devices Moderate Mar 25, 2015
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
FDA Devices Moderate Mar 25, 2015
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
FDA Devices Moderate Mar 25, 2015
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
FDA Devices Moderate Mar 25, 2015
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
FDA Devices Moderate Mar 11, 2015
CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02
FDA Devices Low Dec 10, 2014
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 patients with a higher risk of cancer. The curettes must be used with a suction pump, as well as sterile tubing, and a swivel handle. The rigid plastic suction curette is sterile and disposable. The Cannula Curette is available
FDA Devices Moderate Dec 3, 2014
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.
FDA Devices Low Nov 19, 2014
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 incontinence. This treatment option is a non-invasive method assessing or resolving pelvic organ prolapse and stress incontinence issues
FDA Devices Low Nov 19, 2014
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 incontinence. This treatment option is a non-invasive method assessing or resolving pelvic organ prolapse and stress incontinence issues
FDA Devices Moderate Sep 17, 2014
CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.
FDA Devices Moderate Jun 18, 2014
Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005
FDA Devices Moderate Apr 10, 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 the procedure.
FDA Devices Low Apr 3, 2013
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.
FDA Devices Low Apr 3, 2013
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.
FDA Devices Low Apr 3, 2013
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.
FDA Devices Low Apr 3, 2013
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.
FDA Devices Moderate Apr 3, 2013
Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.
FDA Devices Low Apr 3, 2013
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.
FDA Devices Low Apr 3, 2013
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.
FDA Devices Low Apr 3, 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.
FDA Devices Low Apr 3, 2013
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.
FDA Devices Low Apr 3, 2013
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.
FDA Devices Moderate Dec 5, 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, and/or operative laparoscopy
FDA Devices Moderate Dec 5, 2012
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 of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy
CooperSurgical, Inc. carries an outsized archive share
Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.
Similar recall count
Nearest multi-notice firms by distinct-event totals (97 here — heavy-book).
Similar medical devices volume
Nearest multi-notice firms that share this firm's dominant product category.
Frequently Asked Questions
How many federal recall notices name CooperSurgical, Inc.? ▼
PlainRecalls indexes 97 distinct federal recall events naming CooperSurgical, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does CooperSurgical, Inc. sit among other recalling firms? ▼
CooperSurgical, Inc. ranks #172 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of CooperSurgical, Inc.'s notices? ▼
FDA Devices accounts for 96 of this firm's 97 indexed notices across 2 issuing agencies.
What product category dominates CooperSurgical, Inc.'s filing book? ▼
Filings for CooperSurgical, Inc. span 2 product categories, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
CooperSurgical, Inc.: 97 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.
Firm-level totals aggregate distinct federal recall events naming CooperSurgical, Inc.; individual notices remain authoritative on each linked recall page.
Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026