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CooperSurgical, Inc.

CooperSurgical, Inc. Recalls

All product recalls associated with CooperSurgical, Inc..

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 2921–2940 of 21320 recalls

Global Medium (CooperSurgical) – embryo development risk (2023)

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 blastocyst stage.

High

FDADec 20, 2023Nationwide• CooperSurgical, Inc.

Desloratadine Tablets (Lupin) – Impurity Limit Exceeded (2023)

CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.

Class IIModerate

FDADec 20, 2023Nationwide• Lupin Pharmaceuticals Inc.

Accessory Set Syringes (OriGen) – Qualification Concern (2023)

Accessory sets contain a syringes not yet qualified for the accessory's intended purpose; due to design changes to the syringe barrels and a polypropylene resin change that resulted in loss of gamma compatibility, for accessory set syringes that were gamma sterilized, which resulted in yellowed syringes.

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Moderate

FDADec 19, 2023CA, DE, FL +8 more• OriGen Biomedical, Inc.

Medfusion 3500 Pump (Smiths Medical) – software alarm issue (2023)

Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority Alarm, 2. Infusion Restarted with Incorrect Parameters, 3. Screen Lock, 4. Interruption of Bolus or Loading Dose Delivery, 5. Pump Displays Incorrect Bolus/Loading Dose, 6. Loading/Bolus Dose Below the Minimum Recommended Rate, 7. Motor Rate Error, 8. Incorrect Recall Last Settings, 9. Corrupt Configuration, 10. Auto Lock, 11. Toolbox Configuration Loading Dose Time Values. Smiths Medical corrected all issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent Medfusion software (v6.0.0) installed on your pumps.

High

FDADec 19, 2023Nationwide• Smiths Medical ASD Inc.

Medfusion Barrel Clamp (Smiths Medical) – pump component risk (2023)

Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.

Moderate

FDADec 19, 2023Nationwide• Smiths Medical ASD Inc.

Medfusion 4000 Pump (Smiths Medical) – software alarm issue (2023)

Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the following issues: 1. Delivery During Motor Not Running High Priority Alarm (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 2. Re-administered Loading Dose (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 3. Incorrect Critical Data Failure Alarm, 4. Interruption of Bolus or Loading Dose Delivery (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 5. Incorrect Total Bolus/Loading Dose Displayed (v1.1.0, v1.1.1, v1.1.2), 6. Volume Limit Before Bolus/Loading Dose Complete (v1.1.2), 7. Drug Library Lower Limit Displayed Incorrectly (v1.6.0, v1.6.1), 8. Depleted Battery Alarm (All versions previous to v1.6.5), 9. Loss of Wireless Connectivity (v1.5.0, v1.5.1, v1.6.0, v1.6.1, v1.6.4), 10. PharmGuard Server Password (v2.3, v2.4, v2.5). Smiths Medical corrected all issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent Medfusion software installed on your pumps.

High

FDADec 19, 2023Nationwide• Smiths Medical ASD Inc.

Syringe Pumps (Smiths Medical) – Barrel Clamp Guide Defect (2023)

Moderate

FDADec 19, 2023Nationwide• Smiths Medical ASD Inc.

Medfusion Syringe Pumps (Smiths Medical) – Barrel Clamp Guide Defect (2023)

Moderate

FDADec 19, 2023Nationwide• Smiths Medical ASD Inc.

EndoVive Button Kit (Boston Scientific) – measurement error (2023)

Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead to undersizing the button, which may cause embedding with erosion into the gastric wall, tissue necrosis, infection, sepsis, and associate sequelae.

High

FDADec 19, 2023Nationwide• Boston Scientific Corporation

Intellis Programmer (Medtronic) – Session Establishment Issue (2023)

Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability for the clinician to adjust stimulation parameters. In the event of this issue, the patient may receive inadequate or excessive therapy and experience non-optimal pain relief.

High

FDADec 19, 2023Nationwide• Medtronic Neuromodulation

TactiFlex Ablation Catheter (St. Jude) – System Recognition Issue (2023)

When the catheters are used with the EnSiteX EP System, the system does not correctly recognize the catheter as the appropriate product model and instead reads and displays it as a different model. This results in some features specific to the catheter do not appear on the display and the catheter image may also appear inverted.

High

FDADec 18, 2023Nationwide• St. Jude Medical, Atrial Fibrillation Division, Inc.

ACTU8 Forceps (Vortex Surgical) – Residue Contamination (2023)

Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea. The residue is associated with one lot of forceps tips which were utilized in two lots of ACTU8 Adaptive Forceps Tips occurring in 0.25% of those lots.

Moderate

FDADec 18, 2023Nationwide• Vortex Surgical Inc.

PulseSpray Infusion System (Angiodynamics) – O-Ring Seal Defect (2023)

Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.

High

FDADec 18, 2023Nationwide• Angiodynamics, Inc.

Composilite Lift Axle (Hendrickson) – Bearing Journal Problem (2023)

Hendrickson USA, L.L.C. (Hendrickson) is recalling certain COMPOSILITE EXS20 and SC20 Lift Axles. The bearing journals may not be fully seated in the steering knuckle assemblies, preventing the proper installation of the wheel end hub assemblies.

High

NHTSADec 18, 2023Nationwide• HENDRICKSON

ESG PK Cutting Forceps (Olympus) – Jaw Fracture Risk (2023)

The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.

High

FDADec 15, 2023Nationwide• Olympus Corporation of the Americas

ProxiDiagnost N90 (Philips) – Mixed Patient Images (2023)

Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patient s radiography (RAD) images when starting the next patient scan while the previous patient image export is still processing. If the issue occurs, there is a potential for incorrect patient data to be displayed in the image. Issue 2: Detector Access point: Security vulnerability specific to the Wireless Portable Detector configuration items in Philips Support Connect (PSC). Due to this vulnerability it is possible, with physical access to the system and knowledge of specific settings, to modify and export data to removable media (example: USB)

High

FDADec 15, 2023Nationwide• Philips North America

ExcelsiusGPS Cannula (Globus) – Sterility Concern (2023)

Devices may not be rendered sterile due to an internal gap that may be present on some devices causing increased difficulty cleaning prior to steam sterilization. There is an increased risk for infection, inflammation, local toxicity, systemic toxicity, sensitivity, and cross-contamination.

High

FDADec 15, 2023Nationwide• Globus Medical, Inc.

BrightView XCT Gamma Camera (Philips) – Detector Fall Risk (2023)

Laceration Risk

Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to the patient's lower limbs, as well as an interruption to normal system operation. If detector is positioned above center of gantry, there may be an interruption to normal system operation.

High

FDADec 15, 2023Nationwide• Philips North America

ProxiDiagnost Upgrade (Philips) – Mixed Patient Images (2023)

Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patients radiography (RAD) images when starting the next patient scan while the previous patient image export is still processing. If the issue occurs, there is a potential for incorrect patient data to be displayed in the image. Issue 2: Detector Access point: Security vulnerability specific to the Wireless Portable Detector configuration items in Philips Support Connect (PSC). Due to this vulnerability it is possible, with physical access to the system and knowledge of specific settings, to modify and export data to removable media (example: USB)

High

FDADec 15, 2023Nationwide• Philips North America

BrightView Gamma Camera (Philips) – Detector Fall Risk (2023)

Laceration Risk

High

FDADec 15, 2023Nationwide• Philips North America