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 30, 2025
Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
FDA Devices Moderate Jul 30, 2025
Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
FDA Devices Moderate Jul 30, 2025
HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.
FDA Devices Moderate Dec 25, 2024
Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxid
FDA Devices Moderate Dec 25, 2024
Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide
FDA Devices Moderate Dec 25, 2024
Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbo
FDA Devices Moderate Dec 25, 2024
Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen
FDA Devices Moderate Dec 25, 2024
Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide
FDA Devices Moderate Dec 25, 2024
Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2)
FDA Devices Moderate Oct 2, 2024
Stainless Steel Sims Uterine Sound, Part Number 64-601
FDA Devices Moderate Oct 2, 2024
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D
FDA Devices Moderate Oct 2, 2024
Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A
FDA Devices Moderate Oct 2, 2024
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060A
FDA Devices Moderate Oct 2, 2024
Silver-Plated Copper Sims Uterine Sound, Part Number 64-600
FDA Devices Moderate Feb 21, 2024
global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer.
FDA Devices Moderate Feb 14, 2024
Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason CloseSure System, REF 733776, Contents: One (1) Carter-Thomason Suture Passer, One (1) 5 mm Pilot Guide, One (1) 10/12 mm Pilot Guide.
FDA Devices Moderate Dec 13, 2023
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes. Model: 61-3005
FDA Devices Moderate Dec 13, 2023
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes Model: 61-4005
FDA Devices Moderate Dec 13, 2023
CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes
FDA Devices Moderate Apr 12, 2023
Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060
FDA Devices Moderate Feb 8, 2023
BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)
FDA Devices Moderate Nov 16, 2022
NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
FDA Devices Moderate Oct 5, 2022
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
FDA Devices Moderate Oct 5, 2022
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Mark I model is no longer produced, but the legacy humidifier bottle component design can also be used with the BT37 Mark II Benchtop Incubator.
FDA Devices Moderate Jul 27, 2022
LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
FDA Devices Moderate May 25, 2022
VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.
FDA Drug Critical Feb 23, 2022
PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white rod in a Tyvek polyethylene pouch, Rx Only, Manufactured by Teva Women's Health Inc. a subsidiary of Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 51285-204-01
FDA Devices Moderate Nov 24, 2021
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
FDA Devices Moderate Nov 24, 2021
LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220
FDA Devices Moderate Nov 24, 2021
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W
FDA Devices Moderate Nov 24, 2021
LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
FDA Devices Moderate Nov 24, 2021
LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120
FDA Devices Moderate Nov 24, 2021
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05
FDA Devices Moderate Nov 24, 2021
LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120
FDA Devices Moderate Aug 25, 2021
Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500
FDA Devices Moderate Jun 16, 2021
CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodes, used for electro-excisional procedures, and for electro-fulguration procedures of the lower genital tract
FDA Devices Moderate Jun 2, 2021
The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex. Model Number(s): KCP-30-2
FDA Devices Moderate Mar 10, 2021
Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem Pessary, REF MXKPGSS2-1/4, 2-1/4" (57 mm) with Kit, 2) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-1/4, 2-1/4" (57 mm) without Kit, 3) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-3/4, 2-3/4" (70 mm)
FDA Devices Moderate Oct 21, 2020
MediCult Vitrification Cooling Media, Model Number 12284001F
FDA Devices Moderate Jul 15, 2020
COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176
FDA Devices Moderate Jun 3, 2020
CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
FDA Devices Low Apr 22, 2020
Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - Product Usage: Intended use of the product is the introduction of washed spermatozoa into the uterine cavity.
FDA Devices Moderate Jan 22, 2020
ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperSurgical Product Code: ESPX5) is a sterile, single-use cannula that is part of the Advanced Endosee System. The cannula contains a light source and a camera at the distal end, which can be used for live visualization. The camera can also capture video and images of the diagnostic area for later diagnostic analysis. The Advanced Endosee Cannulas (P/N: ESPX5) are sold in boxes o
FDA Devices Moderate Dec 11, 2019
Quantam 2000 Electrosurgical Generator, Part number 909075-05W.
FDA Devices Moderate Dec 11, 2019
Quantam 2000 Electrosurgical Generator, Part number 909075.
FDA Devices Moderate Dec 11, 2019
Quantam 2000 Electrosurgical Generator, Part number 909075-05.
FDA Devices Low Oct 9, 2019
Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are moved from one dish or tube to another, and safeguards every step of the IVF cycle. While the heated plates comprise a heated composite surface with window for a light source. The heated plates comprise
FDA Devices Low Sep 25, 2019
LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.
FDA Devices Moderate Sep 4, 2019
TransWarmer Warming Infant Transport Mattress, Model no. 20421 Product Usage: The TransWarmer¿ Warming Infant Transport Mattress is gel-filled, disposable mattress that provides heat for up to two hours when cold stress is a concern. The patented WarmGel heats up to 104 (when starting from 75 ) in 60 seconds or less. The product is sold in boxes of 6 Infant Transport Mattresses per box. The intended use of the product is to provide warmth during infant transport within the hospital or betwe
FDA Devices Moderate Jul 31, 2019
LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120
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