CooperSurgical, Inc. recalls
58 recalls in our records from 2014 to 2026: 57 FDA medical devices, 1 FDA drugs.
Recalls with full detail pages
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CooperSurgical, Inc. medical device recall: Inca
Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure,…
Earlier and other recalls
These link to the official agency notice.
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CooperSurgical, Inc. medical device recall: HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is… Official notice ↗
The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches…
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CooperSurgical, Inc. medical device recall: Brand Name: K-Systems Product Name: G73 Dry Bath Incubator… Official notice ↗
The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the…
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CooperSurgical, Inc. medical device recall: Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for… Official notice ↗
Low concentration of sodium pyruvate in the wash could compromise gamete development
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CooperSurgical, Inc. medical device recall: Silver-Plated Copper Sims Uterine Sound Official notice ↗
During the manufacturing process the devices were laser-marked with the incorrect part number.
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CooperSurgical, Inc. medical device recall: global Medium Official notice ↗
The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the…
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CooperSurgical, Inc. medical device recall: Box as labeled: Regard Official notice ↗
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
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CooperSurgical, Inc. medical device recall: Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering… Official notice ↗
Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may…
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CooperSurgical, Inc. medical device recall: Global Total LP single step medium Official notice ↗
It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the…
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CooperSurgical, Inc. medical device recall: Biopsy Medium 10Ml Official notice ↗
The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the embryo.
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CooperSurgical, Inc. medical device recall: NEO-fit Neonatal Endotracheal Tube Grip Official notice ↗
Firm has received 11 complaints involving a loose or detached metal clips, including 3 cases where the metal clip was ingested by the patient, and 3 cases where the…
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CooperSurgical, Inc. medical device recall: Humidifier bottle and syringe filter kit Official notice ↗
There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Damage…
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CooperSurgical, Inc. medical device recall: LifeGlobal Fast Freeze Thawing Kit Official notice ↗
There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rather than…
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CooperSurgical, Inc. medical device recall: Vitriguard Official notice ↗
Products in this lot may have compromised barrier seals, introducing a risk to sterility.
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CooperSurgical, Inc drug recall: Paragard T380A Official notice ↗
Non-sterility
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CooperSurgical, Inc. medical device recall: LEEP PRECISION Integrated System Official notice ↗
Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical…
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CooperSurgical, Inc. medical device recall: Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and… Official notice ↗
Units are displaying output readings that differ from the measurements taken using a Gas Analyzer. When the display is reading a target setting of 5%, an external meter…
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CooperSurgical, Inc. medical device recall: CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131.… Official notice ↗
The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled as a Square Electrode.
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CooperSurgical, Inc. medical device recall: The Ultem Polymeric Resin Koh Cup is a non- sterile Official notice ↗
The affected Koh Cup were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead of a 3.0cm Ultem Koh cup, P/N 34131-03 as required.
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CooperSurgical, Inc. medical device recall: Milex Gellhorn Flexible under the following labels: 1) Gellhorn… Official notice ↗
The affected Milex Gellhorn pessaries were incorrectly manufactured with a long stem (2.170 ), instead of a short stem (1.670 or 1.960 nominal height) as required. The…
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CooperSurgical, Inc. medical device recall: MediCult Vitrification Cooling Media Official notice ↗
There is a discrepancy between the printing on the Product Tyvek label of the individual component packaging. The Chinese characters on the label indicates that it…
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CooperSurgical, Inc. medical device recall: COOPERSURGICAL Os FinderTM Cervical Dilator Official notice ↗
Mislabeled: Printing on the top web or Tyvek lid of the individual product blister tray indicating that it contains a Pipet Current or Part Number MX140 and the display…
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CooperSurgical, Inc. medical device recall: CooperSurgical Dilator/Sound Set Official notice ↗
The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.
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CooperSurgical, Inc. medical device recall: Wallace Artificial Insemination Catheter Official notice ↗
Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years.
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CooperSurgical, Inc. medical device recall: ADVANCED ENDOSEE System CANNULA Official notice ↗
Potential for unsealed pouches in two (2) lots of the Endosee Advance Cannula (P/N: ESPX5).
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CooperSurgical, Inc. medical device recall: Quantam 2000 Electrosurgical Generator Official notice ↗
Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a procedure…
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CooperSurgical, Inc. medical device recall: Embryology Heated Plate within the RI Witness Official notice ↗
The touchpad may not work properly after cleaning.
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CooperSurgical, Inc. medical device recall: LEEP Return Patient Pads Official notice ↗
Discrepancy between the correct expiration dates on the individual pouches inside the boxes and incorrect expiration dates on the outer boxes, where the month and day…
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CooperSurgical, Inc. medical device recall: TransWarmer Warming Infant Transport Mattress Official notice ↗
The firm updated the IFU in April 2019 to clarify that use of the TRANSWARMER Mattress with other heat producing devices, such as an incubator, is prohibited and could…
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CooperSurgical, Inc. medical device recall: LEEP Precision Integrated System 120V & LEEP Precision Generator Official notice ↗
The products' cut, coagulate, or blend function may not operate with the use of the Foot Pedal.
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CooperSurgical, Inc. medical device recall: Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm Official notice ↗
The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious…
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CooperSurgical, Inc. medical device recall: LEEP Precision Integrated System 120V Official notice ↗
2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appropriate 3.15A slow blow fuses.
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CooperSurgical, Inc. medical device recall: ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0 Official notice ↗
ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent
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CooperSurgical, Inc. medical device recall: Colpo-Pneumo Occluder Official notice ↗
The seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
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CooperSurgical, Inc. medical device recall: Retractor System Elastic Stays Official notice ↗
There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
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CooperSurgical, Inc. medical device recall: Fischer Cone Biopsy Excisor Official notice ↗
Products have been packaged with an incorrect product size.
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CooperSurgical, Inc. medical device recall: 5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended… Official notice ↗
Products have been packaged with the wrong Trocar length type.
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CooperSurgical, Inc. medical device recall: Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical… Official notice ↗
The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe
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CooperSurgical, Inc. medical device recall: CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual… Official notice ↗
The current secondary packaging, a box, incorrectly states that the product is latex free. The product is made with 100% latex. The label on the package that contains…
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CooperSurgical, Inc. medical device recall: Sage In-Vitro Fertilization- CSC Official notice ↗
Products contain international package insert and not the correct USA package insert
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CooperSurgical, Inc. medical device recall: Milex Arcing Diaphragm Size 95 Official notice ↗
The products have been identified to contain an incorrect size Diaphragm.
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CooperSurgical, Inc. medical device recall: Milex Pessary Kit Official notice ↗
The products have been identified to have incorrect size prints on the MILEX PESSARY KIT packaging. While the Pessary pouch is marked with correct size, an incorrect…
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CooperSurgical, Inc. medical device recall: CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for… Official notice ↗
Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%)
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CooperSurgical, Inc. medical device recall: Infant Heel Warmer and Infant Gel Warmer Official notice ↗
Product marketed without a 510(k)
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CooperSurgical, Inc. medical device recall: Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product… Official notice ↗
Incorrect expiration date on outer carton kit label
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CooperSurgical, Inc. medical device recall: McKesson Medi-Pak Vaginal Speculum Official notice ↗
Small sized specula were incorrectly packaged in printed bags for the medium sized speculum
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CooperSurgical, Inc. medical device recall: MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80 Official notice ↗
A diaphragm size 80 labeled box was incorrectly packaged with a size 85.
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CooperSurgical, Inc. medical device recall: Ally Uterine Positioning System Official notice ↗
Design of device may expose user to injury to fingers or body parts
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CooperSurgical, Inc. medical device recall: Carter-Thomason II Port Closure System Official notice ↗
The pad printing around the suture entry holes on the 15mm Suture Guide included in the kit may not have been appropriately manufactured resulting in the pad printing…
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CooperSurgical, Inc. medical device recall: WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number… Official notice ↗
Internal gas line may malfunction causing the line to burst under pressure.
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CooperSurgical, Inc. medical device recall: CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N… Official notice ↗
Trans Warmer Infant and Transport Mattress not labeled with exp.date may not meet specification
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CooperSurgical, Inc. medical device recall: CooperSurgical Infant Heel Gel Warmers Official notice ↗
Products without expiration date have the remote potential for minor burn
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CooperSurgical, Inc. medical device recall: CooperSurgical PESSARY KIT-CUBE#2 Official notice ↗
Incorrect size printed on the Milex Pessary Kit packaging label
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CooperSurgical, Inc. medical device recall: Cooper Surgical CANNULA-CURETTE 12MM Official notice ↗
The product has been identified to contain an incorrect curette type.
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CooperSurgical, Inc. medical device recall: CooperSurgical LEEP RADIUS LOOP ELECTRODE Official notice ↗
Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode
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CooperSurgical, Inc. medical device recall: CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1… Official notice ↗
Incorrect expiration date printed on the MILEX PESSARY KIT packaging
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CooperSurgical, Inc. medical device recall: CooperSurgical H/S CATHETER Official notice ↗
Unsealed pouches.
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CooperSurgical, Inc. medical device recall: Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for… Official notice ↗
Sterility of the device may be compromised due to unsealed pouch
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.