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.

26–50 of 84

  • HighFDA (Devices)·Z-1108-2022·2022-05-25

    VitriGuard Cryopreservation Storage Device Recalled for Sterility Risk

    CooperSurgical is recalling 2,340 VitriGuard cryopreservation devices with compromised barrier seals that may compromise sterility. The affected devices were distributed across ten U.S. states.

    Product
    VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.
    Category
    Medical Device
    Distribution
    10 states
  • SevereFDA (Drugs)·D-0643-2022·2022-02-23

    Paragard T380A Intrauterine Contraceptive Device Recall for Non-Sterility

    CooperSurgical, Inc is recalling 48,645 cartons of Paragard T380A intrauterine contraceptive devices nationwide due to non-sterility concerns. The voluntary recall affects Lot #517001 with expiration date 1/2024.

    Product
    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 51
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0259-2022·2021-11-24

    LEEP PRECISION Generator 120V Hand Switch Coagulation Function Failure

    CooperSurgical is recalling 244 LEEP PRECISION Generator 120V units because the hand switch's coagulation function may fail to operate properly, potentially requiring medical intervention to control bleeding during surgical procedures.

    Product
    LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0261-2022·2021-11-24

    Quantum 2000 Electrosurgical Generator Hand Switch Coagulation Failure

    CooperSurgical Quantum 2000 Electrosurgical Generators may fail to coagulate tissue when using the hand switch during surgery, potentially extending procedures and requiring medical intervention to control intraoperative bleeding. The Class II recall affects 193 units.

    Product
    Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0262-2022·2021-11-24

    Electrosurgical Generator Coagulation Function May Fail During Surgery

    CooperSurgical recalled 700 Quantum 2000 Electrosurgical Generators due to a hand switch coagulation function defect that may fail to operate during surgery, potentially requiring medical intervention to control intraoperative bleeding.

    Product
    Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0258-2022·2021-11-24

    LEEP PRECISION Integrated System may fail to coagulate during surgery

    CooperSurgical is recalling 75 units of the LEEP PRECISION Integrated System due to a defect where the hand switch may not activate the coagulation function, potentially causing prolonged surgery and bleeding complications.

    Product
    LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0257-2022·2021-11-24

    LEEP PRECISION Electrosurgical System Coagulation Function May Fail

    CooperSurgical's LEEP PRECISION System may fail to coagulate tissue when using the hand switch, potentially requiring medical intervention to control intraoperative bleeding during procedures.

    Product
    LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0260-2022·2021-11-24

    LEEP PRECISION Surgical Generator May Fail to Coagulate During Surgery

    CooperSurgical is recalling 75 units of the LEEP PRECISION Generator 220V because the coagulation hand switch may fail, potentially causing uncontrolled bleeding during surgery.

    Product
    LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0263-2022·2021-11-24

    FDA Class II Quantum 2000 Electrosurgical Generators Voluntary Recall

    CooperSurgical is voluntarily recalling 154 Quantum 2000 Electrosurgical Generators under FDA Class II classification. The specific reason for recall is not documented in available source information.

    Product
    Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2307-2021·2021-08-25

    Oxygen Sensors in Incubators May Display Inaccurate Readings

    CooperSurgical oxygen sensors in incubators may display inaccurate oxygen readings that do not trigger alarms when discrepancies occur. This could result in loss of embryos during storage.

    Product
    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 Standa
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1847-2021·2021-06-16

    CooperSurgical Wallach Loop Electrode recalled for incorrect packaging

    CooperSurgical has recalled its Wallach Loop Electrodes (Lot 274420) due to incorrect packaging. Packages labeled as Square Electrodes contained Round Electrodes instead, creating a risk of improper device use in surgical procedures.

    Product
    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
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1686-2021·2021-06-02

    CooperSurgical Recalls Incorrectly Packaged Ultem Koh Cup Vaginal Delineators

    CooperSurgical is recalling specific Koh Cup vaginal delineators that were incorrectly packaged with a 3.5cm cup instead of the required 3.0cm model.

    Product
    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
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1152-2021·2021-03-10

    CooperSurgical Recalls Milex Gellhorn Flexible Pessaries Due to Manufacturing Error

    CooperSurgical is recalling specific lots of Milex Gellhorn Flexible pessaries because they were manufactured with incorrect stem lengths.

    Product
    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 MXPGSS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2498-2020·2020-07-15

    CooperSurgical Recalls Mislabeled Os Finder Cervical Dilators

    CooperSurgical is recalling 2,250 Os Finder Cervical Dilators due to mislabeled blister trays. The product inside is correct, but the packaging label is incorrect.

    Product
    COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1713-2020·2020-04-22

    CooperSurgical Recalls Wallace Catheters Due to Expiration Date Error

    CooperSurgical is recalling Wallace Artificial Insemination Catheters because the expiration date was marked as 5 years instead of 3 years.

    Product
    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.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0798-2020·2020-01-22

    CooperSurgical Recalls Advanced Endosee Cannulas Due to Unsealed Pouches

    CooperSurgical is recalling 460 boxes of Advanced Endosee Cannulas because some sterile pouches may be unsealed, potentially compromising sterility.

    Product
    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
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-0602-2020·2019-12-11

    CooperSurgical Recalls Quantum 2000 Electrosurgical Generators Due to Malfunction

    CooperSurgical is recalling Quantum 2000 Electrosurgical Generators because they may stop cutting, coagulating, or blending during procedures when the foot pedal is used.

    Product
    Quantam 2000 Electrosurgical Generator, Part number 909075-05W.
    Category
    Medical Device
    Distribution
    28 states
  • LowFDA (Devices)·Z-0029-2020·2019-10-09

    CooperSurgical Embryology Heated Plate Recall Due to Touchpad Malfunction

    CooperSurgical is recalling 60 Embryology Heated Plates within the RI Witness system because the touchpad may not work properly after cleaning.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2545-2019·2019-09-25

    CooperSurgical Recalls LEEP Return Patient Pads Due to Expiration Date Errors

    CooperSurgical is recalling LEEP Return Patient Pads because the expiration dates on the outer boxes have the month and day reversed compared to the individual pouches.

    Product
    LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2364-2019·2019-09-04

    CooperSurgical Recalls TransWarmer Infant Mattresses Due to Burn Risk

    CooperSurgical is recalling TransWarmer Warming Infant Transport Mattresses because some units lack updated instructions prohibiting use with other heat devices, which could cause skin burns.

    Product
    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 (whe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2057-2019·2019-07-31

    CooperSurgical LEEP Precision System Foot Pedal Function Defect Recall

    CooperSurgical is recalling LEEP Precision Integrated Systems because the foot pedal may fail to operate the cut, coagulate, or blend functions.

    Product
    LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120
    Category
    Medical Device
    Distribution
    Distributed nationwide