CooperSurgical, Inc recalls
Every recall we track for CooperSurgical, Inc — 61 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them. 4 are rated “stop using now”.
Recalls per year, by danger level
Recalls from CooperSurgical, Inc fell by more than half in 2025 (3, down from 11 in 2024). 7% rated “stop using now”.
All FDA recall records for CooperSurgical, Inc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 1 | 0 | 1 |
| 2018 | 0 | 0 | 4 | 0 | 4 |
| 2019 | 3 | 4 | 5 | 0 | 12 |
| 2020 | 0 | 0 | 3 | 1 | 4 |
| 2021 | 0 | 6 | 4 | 1 | 11 |
| 2022 | 1 | 3 | 5 | 1 | 10 |
| 2023 | 0 | 0 | 3 | 0 | 3 |
| 2024 | 0 | 2 | 9 | 0 | 11 |
| 2025 | 0 | 0 | 3 | 0 | 3 |
| 2026 (to date) | 0 | 1 | 0 | 1 | 2 |
What to do if you have a recalled CooperSurgical, Inc product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All CooperSurgical, Inc recalls
38 shown- Use cautionMedical device
CooperSurgical, Inc. recalls INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box.
CooperSurgical recalls 4 model neonatal CPAP replacement sets with Stay-Flex tubing that may become loose, reducing CPAP pressure and oxygenation. Affected units have specific model numbers and lot codes.
CooperSurgicalAug 11, 2026 - Lower riskMedical device
CooperSurgical, Inc. recalls Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
CooperSurgical recalls Endosee System Convenience Kit with IV Tube (model ES-TRAY-IV) due to non-sterile iodine pouches labeled as sterile. Affected units include specific lot numbers and model.
CooperSurgicalJun 11, 2025 - Lower riskMedical device
CooperSurgical, Inc. recalls Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product
CooperSurgical recalls K-Systems G85 Mini Incubators with model K22074 that may overheat during assisted reproduction procedures, causing potential temperature control issues.
K-SystemsNov 15, 2024 - Lower riskMedical device
CooperSurgical, Inc. recalls Stainless Steel Sims Uterine Sound, Part Number 64-601
CooperSurgical recalls stainless steel Sims Uterine Sound (part 64-6:601) due to incorrect laser marking during manufacturing. Affected units may have wrong part numbers and should be checked.
CooperSurgicalJul 31, 2024 - Lower riskMedical device
CooperSurgical, Inc. recalls Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D
CooperSurgical recalls Origio Sperm Wash Medium Pack of Five 60ml bottles due to potential low sodium pyruvate concentration affecting gamete development. No remedy specified in the recall notice.
CooperSurgicalFeb 16, 2024 - Lower riskMedical device
CooperSurgical, Inc. recalls global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use:
CooperSurgical recalls three embryo culture bottle models (20mL, 50mL, 100mL) after reports of impaired embryo development. Affected units may need replacement to prevent issues during early embryonic growth.
CooperSurgicalDec 20, 2023 - Lower riskMedical device
CooperSurgical, Inc. recalls Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled:
CooperSurgical recalls CloseSure System XL kits with incorrect component descriptions on Tyvek lid. Affected kits may have missing parts; contact for replacement.
CooperSurgicalAug 29, 2023 - Lower riskMedical device
CooperSurgical, Inc. recalls Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference
CooperSurgical recalls 60mL Global Total LP embryo culture medium that may lack required protein for embryo development. Affected units have specific lot numbers and reference codes.
CooperSurgicalFeb 13, 2023 - Lower riskMedical device
CooperSurgical, Inc. recalls BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for
CooperSurgical recalls BIOPSY MEDIUM 10ML (Lot 220506-006557) due to potential embryo degradation from incorrect medium. Affected units may cause embryo damage during IVF procedures.
CooperSurgicalDec 15, 2022 - Stop using nowMedical device
CooperSurgical, Inc. recalls NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
CooperSurgical recalls NEO-fit Neonatal Endotracheal Tube Grip (Part 42-2540) due to loose metal clips that have been ingested by patients or caused throat lacerations.
CooperSurgicalOct 20, 2022 - Lower riskMedical device
CooperSurgical, Inc. recalls Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
CooperSurgical recalls humidifier bottles and syringe filter kits for BT37 Mark II incubators due to potential sterile barrier breaches causing embryo contamination. Affected units include specific lot numbers.
CooperSurgicalAug 12, 2022 - Lower riskMedical device
CooperSurgical, Inc. recalls LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
CooperSurgical recalls LifeGlobal Fast Freeze Thawing Kit Model GFT5-055 due to Spanish instructions incorrectly stating 5-minute air thaw instead of 5 seconds. This could lead to improper freezing.
CooperSurgicalJun 13, 2022 - Lower riskMedical device
CooperSurgical, Inc. recalls VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of
CooperSurgical recalls VITRIGUARD carrier clear cryopreservation storage devices with model 43782001 due to potential compromised barrier seals that could introduce contamination.
CooperSurgicalApr 1, 2022 - Use cautionMedical device
CooperSurgical, Inc. recalls Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or
CooperSurgical recalls H/S ELLIPTOSPHERE CATH : Incorrect bonding material may cause detachment, delaying procedures. Affected units have model 61-3005 and specific serial numbers.
CooperSurgicalMar 31, 2022 - UnratedDrug
CooperSurgical, Inc recalls PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white
CooperSurgical recalls PARAGARD T380A intrauterine copper contraceptives due to non-sterility risk. One unit per carton with insertion tube and white rod is affected. No remedy specified in official notice.
CooperSurgicalFeb 4, 2022 - Use cautionMedical device
CooperSurgical, Inc. recalls Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
CooperSurgical recalls Quantum 2000 Electrosurgical Generators with part number 909075 due to potential coagulation failure during surgery, requiring medical intervention for bleeding.
CooperSurgicalSep 29, 2021 - Lower riskMedical device
CooperSurgical, Inc. recalls Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use
CooperSurgical recalls Oxygen Sensor Model K54019-2 used in G185 & G210 Incubators and G603 Work Chambers. Sensors may display incorrect oxygen levels, risking embryo loss during storage.
CooperSurgicalJun 30, 2021 - Lower riskMedical device
CooperSurgical, Inc. recalls CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodes,
CooperSurgical recalls 10mm x 10mm Square Wallach Loop Electrodes (P/N 909131) that were incorrectly packaged with round electrodes. This packaging error may lead to incorrect use during medical procedures.
CooperSurgicalApr 30, 2021 - Lower riskMedical device
CooperSurgical, Inc. recalls The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade
CooperSurgical recalls Koh Cup 3.5cm model (P/N 34131-04) due to incorrect packaging. This model is not the required 3.0cm size and may cause improper use during vaginal procedures.
CooperSurgicalApr 23, 2021 - Lower riskMedical device
CooperSurgical, Inc. recalls Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem Pessary, REF MXKPGSS2-1/4, 2-1/4"
CooperSurgical recalls Milex Gellhorn Flexible pessaries with incorrect stem length that may cause improper fit or displacement. Affected models include specific reference numbers and lots.
CooperSurgicalJan 21, 2021 - UnratedMedical device
CooperSurgical, Inc. recalls MediCult Vitrification Cooling Media, Model Number 12284001F
CooperSurgical recalls MediCult Vitrification Cooling Media Model 12284001F due to label printing error showing wrong product type. Affected units sold in 2023 with specific lot number.
CooperSurgicalSep 8, 2020 - Lower riskMedical device
CooperSurgical, Inc. recalls COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176
CooperSurgical recalls Os Finder Cervical Dilators (Part 1176) due to mislabeling. Products may show incorrect part numbers on packaging. Consumers should check labels and contact the company for details.
CooperSurgicalJun 3, 2020 - Lower riskMedical device
CooperSurgical, Inc. recalls CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
CooperSurgical recalls sterile cervical dilator sets with potentially compromised pouch seals. Affected units from specific lot number may pose infection risk if used improperly.
CooperSurgicalApr 9, 2020 - Lower riskMedical device
CooperSurgical, Inc. recalls Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical
Cooper Surgical recalls 10-unit boxes of Wallace Artificial Insemination Catheters (Model AIC18JP) due to incorrect 5-year expiry date instead of 3-year safety expiry. This affects fertility treatments and requires immediate verification.
Cooper SurgicalFeb 28, 2020 - Lower riskMedical device
CooperSurgical, Inc. recalls ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula
Cooper Surgical recalls Endosee Cannula (ESPX5) with potential unsealed pouches in two lots. Affected units may have pouches that could leak, causing contamination. Stop using and contact for replacement.
Cooper SurgicalDec 13, 2019 - Use cautionMedical device
CooperSurgical, Inc. recalls Quantam 2000 Electrosurgical Generator, Part number 909075-05W.
CooperSurgical recalls Quantam 2000 Electrosurgical Generators with specific part numbers and serial ranges due to potential failure to cut, coagulate, or blend during procedures when foot pedal is used.
CooperSurgicalOct 16, 2019 - Lower riskMedical device
CooperSurgical, Inc. recalls Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI
CooperSurgical recalls Embryology Heated Plate models 6-70-807, 6-70-807-A, and 6-70-807-B due to touchpad malfunction after cleaning. This affects IVF lab equipment used for embryo temperature control.
CooperSurgicalSep 5, 2019 - Lower riskMedical device
CooperSurgical, Inc. recalls LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.
CooperSurgical recalls LEEP Return Patient Pads with reversed expiration dates on outer boxes. This could lead to expired pads being used in procedures. Affected lots: 201809125 and 2: 201809135.
CooperSurgicalAug 19, 2019 - Use cautionMedical device
CooperSurgical, Inc. recalls TransWarmer Warming Infant Transport Mattress, Model no. 20421 Product Usage: The TransWarmer¿ Warming Infant Transport
CooperSurgical recalls TransWarmer Warming Infant Transport Mattress Model 20421 due to risk of skin burns if used with incubators. Some units lack updated safety instructions.
CooperSurgicalJul 8, 2019 - Lower riskMedical device
CooperSurgical, Inc. recalls LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120
CooperSurgical recalls LEEP Precision Integrated System 120V and Generator models LP-10-120 and LP-20-120 due to potential failure of cut, coagulate, or blend functions when using the foot pedal.
CooperSurgicalJun 18, 2019 - Stop using nowMedical device
CooperSurgical, Inc. recalls Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm; Part No. AD750SC-KE30 The Advincula Delineator Uterine
CooperSurgical recalls Advincula Delineator size 3.0 cm soft cups due to potential cracking from excessive compressions, which could cause lacerations during uterine procedures.
CooperSurgicalJun 14, 2019 - Stop using nowMedical device
CooperSurgical, Inc. recalls LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V
CooperSurgical recalls LEEP Precision Integrated System 120V models with potentially incorrect fuses that could lead to fire. Affected units were sold starting in 2018. Consumers should contact CooperSurgical for details.
CooperSurgicalApr 23, 2019 - Lower riskMedical device
CooperSurgical, Inc. recalls ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0
CooperSurgical recalls ICSI MicroPipettes with part number MICC001-30-B1.0 due to missing 30-degree bend. Affected units sold in 2023.
CooperSurgicalMar 27, 2019 - Lower riskMedical device
CooperSurgical, Inc. recalls Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part
CooperSurgical recalls Retractor System Elastic Stays (parts 3314-lG, 3316-lG, 3550-lG) due to possible compromised sterile pouch seals increasing infection risk. Affected lots include 244660, 245964, 250426, 251395, 244667, 244883, 244884, 245603, 245973, 246138, and 248871.
CooperSurgicalSep 4, 2018 - Lower riskMedical device
CooperSurgical, Inc. recalls Colpo-Pneumo Occluder, Part CPO-6
CooperSurgical recalls Colpo-Pneumo Occluder Part CPO-6 with specific lot numbers due to potential infection risk from compromised sterile pouch seals. Affected patients should contact the manufacturer for guidance.
CooperSurgicalSep 4, 2018 - Lower riskMedical device
CooperSurgical, Inc. recalls 5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count); Model Number 900-840 Product Usage:
CooperSurgical recalls 5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar (Model 90: 223333) due to incorrect packaging. This may cause improper surgical use. Affected users should contact CooperSurgical for details.
CooperSurgicalMar 12, 2018 - Lower riskMedical device
CooperSurgical, Inc. recalls Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151
CooperSurgical recalls Fischer Cone Biopsy Excisor Medium (5/Box) model 900-151 due to incorrect packaging. Consumers should check product details to determine if affected.
CooperSurgicalMar 12, 2018 - Lower riskMedical device
CooperSurgical, Inc. recalls Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use
CooperSurgical recalls 2 MHz Waterproof OB probes due to being incorrectly labeled as 3 MHz. This may cause inaccurate fetal heart rate readings during obstetrical exams.
CooperSurgicalOct 6, 2017
CooperSurgical, Inc recall questions
How many recalls has CooperSurgical, Inc had?
61 recalls from CooperSurgical, Inc are on record with U.S. safety agencies, from 2017–2026 (60 medical device, 1 drug).
What is the most recent CooperSurgical, Inc recall?
CooperSurgical, Inc. recalls INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box., dated Aug 11, 2026. Every CooperSurgical, Inc recall is listed on this page, newest first.
What should I do if I have a recalled CooperSurgical, Inc product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new CooperSurgical, Inc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.