PlainRecalls

CooperSurgical, Inc

Compiled from official public sources by the editorial team.

84 recalls on record · Latest: Jul 30, 2025

CooperSurgical, Inc Recall Insight

CooperSurgical, Inc appears on 84 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.083% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Jul 30, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 1 critical, 46 moderate, and 3 lower-severity recalls. Affected-unit counts are disclosed on 49 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 2 distinct product categories, with issuing agencies dominated by FDA Devices (49), FDA Drug (1). The date window on this page runs from Jul 31, 2019 to Jul 30, 2025.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

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-po…

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-pow…

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 electri…

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 intend…

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-pow…

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 d…

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 zyg…

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 CloseS…

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 …

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 dete…

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 Hystero…

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 produ…

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 pou…

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 …

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…

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 nat…

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) Gellhor…

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 - …

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…

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 Iden…

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, …

FDA Devices Moderate Jul 31, 2019

LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare CooperSurgical, Inc with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.