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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 4701–4720 of 21320 recalls

Biopsy Medium (CooperSurgical) – Incorrect Medium Risk (2022)

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.

Moderate

FDADec 15, 2022GA• CooperSurgical, Inc.

SPiN Thoracic Navigation System (Olympus) – Imaging Quality (2022)

A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-7100 or INS-7130) with the SYS-4000 system due to an incorrect DVI cable supplied may result in prolonged procedure/surgery due to additional time to troubleshoot the device

Moderate

FDADec 13, 2022FL, GA, IN +8 more• Olympus Corporation of the Americas

Epoc Host 2 (Siemens) – Quality Control Pressure (2022)

pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure

Moderate

FDA

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Page 236 of 1066Next

Dec 12, 2022

Nationwide

• Siemens Healthcare Diagnostics Inc

Cobas Infinity Central Lab (Roche) – Order Rejection Issue (2022)

A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA) could occur where the order received from the Laboratory Information System (LIS) is created with an Internal ID rather than the External ID sent from the LIS. The erroneous event occurs under rare circumstances where the date in the sample's barcode does not match the order date sent from the LIS, and can lead to the order being mismatched to an another patient's sample ID rather than the subject patient's sample ID. The software bug impacts multiple cobas infinity central lab software (versions 2.5.x , 3.01.x, 3.02.x, and 3.03.x) and occurs when the afflicted software has been configured with specific pre-conditions.

Moderate

FDADec 12, 2022Nationwide• Roche Diagnostics Operations, Inc.

Perfusion Tubing Packs (Medtronic) – Temperature Adapter (2022)

An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.

Moderate

FDADec 12, 2022Nationwide• Medtronic Perfusion Systems

Affinity Fusion Oxygenator (Medtronic) – Temperature Adapter (2022)

Moderate

FDADec 12, 2022Nationwide• Medtronic Perfusion Systems

Pepper Collection Gift Set (Something SA) – mold contamination (2022)

Due to presence of mold (Aspergillus brasiliensis) and Ochratoxin A.

Class IIModerate

FDADec 12, 2022Nationwide• Something South African LLC

Rifampin Capsules (Lupin) – Impurity Specifications (2022)

Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.

Class IIModerate

FDADec 12, 2022Nationwide• Lupin Pharmaceuticals Inc.

Neuroquell Plus Homeopathic Drug (Atlantic) – cGMP Issues (2022)

cGMP Deviations

Class IIModerate

FDADec 12, 2022Nationwide• Atlantic Management Resources Ltd.

ProSirona Homeopathic Formula (Atlantic) – cGMP Issues (2022)

cGMP Deviations

Class IIModerate

FDADec 12, 2022Nationwide• Atlantic Management Resources Ltd.

Neuroquell Homeopathic Drug (Atlantic) – cGMP Issues (2022)

cGMP Deviations

Class IIModerate

FDADec 12, 2022Nationwide• Atlantic Management Resources Ltd.

Menastil Homeopathic Formula (Atlantic) – cGMP Issues (2022)

cGMP Deviations

Class IIModerate

FDADec 12, 2022Nationwide• Atlantic Management Resources Ltd.

AXIOM Luminos Agile (Siemens) – Footrest Detachment (2022)

There is potential for the footrest to detach from the patient table during use.

Moderate

FDADec 9, 2022Nationwide• Siemens Medical Solutions USA, Inc

Luminos Max Systems (Siemens) – Footrest Detachment (2022)

There is potential for the footrest to detach from the patient table during use. Device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric, adult, and bariatric patients. These devices are not for mammography examinations.

Moderate

FDADec 9, 2022Nationwide• Siemens Medical Solutions USA, Inc

CADD Administration Set (Smiths Medical) – Delivery Issues (2022)

There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms

High

FDADec 9, 2022Nationwide• Smiths Medical ASD Inc.

AXIOM Luminos Systems (Siemens) – Footrest Detachment (2022)

There is potential for the footrest to detach from the patient table during use.

Moderate

FDADec 9, 2022Nationwide• Siemens Medical Solutions USA, Inc

Cordless Window Shades Battery Packs (Dooya) – Fire Hazard (2022)

Fire/Burn Risk

This recall involves external lithium-ion battery packs used to power cordless window blinds. The recalled battery packs are white and are approximately10.5 inches long by approximately 1 inch in diameter. The recalled battery packs weigh about 10 ounces. The recalled battery packs have numerical codes on the white label on the side of the product. The following models and production lots are included in the recall. The model and production lots are printed on the battery. Retailer/Brands Model Name Marks on Label for Affected Batch 3 Day Blinds Alta PN 62203000 "2550mAh" with no PO# & "2550mAh" with PO# Range: 231866, 223081, 225204, 226910, 4200007528, 4200007887, 4200007888 Budget Blinds Blinds.com Blinds to Go The Shade Store Other Brands May Be Affected. Please check your product label MT03-0305-069003 "2550mAh"

High

CPSCDec 8, 2022Nationwide• Dooya Mechanic & Electronic Tech Co., of Ningbo, China

IC Bus CESB (IC Bus) – Torque Arm Fasteners (2022)

Navistar, Inc. (Navistar) is recalling certain 2023 IC RE, IC EV, and 2023-2024 IC CE school buses. The fasteners that connect the transverse torque arm to the rear axle housing may have been tightened incorrectly, which can allow the rear axle to shift side to side.

Very High

NHTSADec 8, 2022Nationwide• IC BUS

RadiaLux Lighted Retractor (Medtronic) – Sterile Seal Defect (2022)

Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.

Moderate

FDADec 8, 2022Nationwide• Medtronic Navigation, Inc.

Michelin X Tire (Michelin) – Tire Markings (2022)

Michelin North America, Inc. (Michelin) is recalling certain X, XWX, Pilote X, XVS, TRX, MXV, XAS, TB 15, XDX, ZX, VHC, TB 5, XM+, and PB 20 specialty tires, sold for use on certain vintage and antique vehicles. Please see the attached products listing for a complete list of all affected tires and sizes. The DOT certification symbol is missing from the tire sidewalls. As such, these tires fail to comply with the requirements of Federal Motor Vehicle Safety Standard numbers 109, "New Pneumatic and Certain Specialty Tires," and 139, "New Pneumatic Radial Tires for Light Vehicles."

Low

NHTSADec 8, 2022Nationwide• MICHELIN