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Cook Medical Incorporated

Cook Medical Incorporated Recalls

All product recalls associated with Cook Medical Incorporated.

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Recall Summary

Total Recalls

1000

Past Year

891

Class I (Serious)

124

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 4321–4340 of 17593 recalls

Celect PlatinumVena Cava Filter (Cook) – instructions update (2022)

IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events

Low

FDAFeb 14, 2022Nationwide• Cook Medical Incorporated

Gunther Tulip Vena Cava Filter (Cook) – instructions update (2022)

IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events

Low

FDAFeb 14, 2022Nationwide• Cook Medical Incorporated

CombiDiagnost R90 1.1 (Philips Medical) – Patient Data Overlap (2022)

While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.

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Moderate

FDAFeb 11, 2022Nationwide• PHILIPS MEDICAL SYSTEMS

RayStation/RayPlan (RaySearch) – dose calculation error (2022)

Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system.

Moderate

FDAFeb 11, 2022Nationwide• RaySearch America Inc

CombiDiagnost R90 1.0 (Philips Medical) – Patient Data Overlap (2022)

Moderate

FDAFeb 11, 2022Nationwide• PHILIPS MEDICAL SYSTEMS

HCG Injection (Revive Rx) – Bacterial Contamination (2022)

Non-sterility; bacterial contamination identified as Paenibacillus lautus.

Class IHigh

FDAFeb 11, 2022Nationwide• Revive Rx LLC dba Revive Rx Pharmacy

Perfect Sleeper Mattresses (Serta) – Flammability Risk (2022)

Fire/Burn Risk

This recall involves Serta Perfect Sleeper-branded mattresses. The white single-sided mattresses have navy blue side panels and were sold in twin, twin XL, full, queen, king and California king sizes. They were manufactured from July 15, 2021 through August 6, 2021. The date of manufacture in DD/MM/YY, the model number and "Prototype ID: L1" can be found on a white tag sewn into the head of the mattress. The following model numbers are included in this recall: 500102413 500105863 500108763 500702313 500102513 500106563 500109563 500952763 500102863 500106663 500302913 500953063 500102963 500106763 500304013 500960143 500103063 500107263 500701113 500960243 500103163 500107463 500702013 500960443 500702313

High

CPSCFeb 10, 2022Nationwide• SSB Manufacturing Company, of Doraville, Ga.

Diazepam Oral Solution (Lannett) – Impurity Specification Failure (2022)

Failed Impurities/Degradation Specifications: Out of specification results for related substances.

Class IIModerate

FDAFeb 9, 2022Nationwide• Lannett Company, Inc.

Fresh Enoki Mushrooms (Concord Farms) – listeria contamination (2022)

Listeria

California Department of Public Health sampled product and found it to contain Listeria monocytogenes.

Class IHigh

FDAFeb 9, 2022CA, NV• Concord Farms, Inc.

Saladitos (American Gourmet) – high lead levels (2022)

California Department of Public Health sampled product and found it to contain high levels of lead.

Class IIModerate

FDAFeb 7, 2022CA• American Gourmet

TCL1 Breakapart Probe (Cytocell) – Unexpected Locus Signal (2022)

May show unexpected locus specific signals in addition to those at 14q32.

Moderate

FDAFeb 4, 2022MN• Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom

Cardiovascular Procedure Kit (Terumo) – Packaging Damage (2022)

Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.

Low

FDAFeb 3, 2022Nationwide• Terumo Cardiovascular Systems Corp

Mevion Proton Therapy System (Mevion) – Hand Pendant Malfunction (2022)

Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle or other objects in the treatment room.

Moderate

FDAFeb 1, 2022Nationwide• Mevion Medical Systems, Inc.

Ice Cream Products (Royal Ice Cream) – Listeria Risk (2022)

Listeria

Product may be contaminated with Listeria monocytogenes.

Class IHigh

FDAFeb 1, 2022AZ, CT, FL +18 more• The Royal Ice Cream Company Inc.

INFX-8000V (Canon Medical) – Fluoroscopic Dose Rate (2022)

The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.

Low

FDAJan 31, 2022Nationwide• Canon Medical System, USA, INC.

STANDARD Q COVID-19 Ag Home Test (SD Biosensor) – Unauthorized Import (2022)

Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or authorized for distribution within the U.S.

Low

FDAJan 31, 2022Nationwide• SD Biosensor, Inc. 1556 Beon-Gil, Yeongtong C4th & 5th Floor Digital Empire

Tempus LS (Remote Diagnostic) – Unauthorized Distribution (2022)

Distribution of Defibrillators that are not approved or cleared for distribution US Market.

Low

FDAJan 28, 2022Nationwide• Remote Diagnostic Technologies Ltd. PAVILION C2, ASHWOOD PARK ASHWOOD WAY Basingstoke United Kingdom

MiniMed Insulin Pump (Medtronic) – Incorrect Pre-Programming (2022)

New or replacement insulin pumps are not pre-programmed with basal rates or other verified settings (bolus wizard settings, sensor settings, etc.), which must be set up and saved on pumps prior to use. Patients who do not realize this will receive no basal insulin, which can lead to insulin under-delivery. Insulin under-delivery can cause severe hyperglycemia, which may lead to diabetic ketoacidosis. Current device labeling does not clearly identify that these insulin pumps are capable of functioning with the default basal setting of 0.0 units/hr for all 24 hours and that no error message will appear if the default basal setting remains active. Furthermore, the labeling for the affected devices does not highlight that saving the basal settings requires multiple steps and failure to complete all steps will not save the new basal settings, nor that the steps required to set and save a basal profile and other parameters which are used as part of the bolus calculator function are different.

High

FDAJan 27, 2022AL, AK, AZ +49 more• Medtronic MiniMed

Over-the-Counter Drugs (Geri-Care) – Packaging Issue (2022)

This recall involves bottles of Geri-Care Brand over-the-counter acetaminophen and aspirin. The acetaminophen is 500mg with 1,000 tablets in the bottle. The aspirin was sold in 81mg with 300 and 1,000 tablets in the bottle and 325mg with 250 and 1,000 tablets in the bottle. Product Count Extra Strength Acetaminophen 500mg Tablets 1,000 Regular Strength Enteric Coated Aspirin 325mg Tablets 250 Regular Strength Enteric Coated Aspirin 325mg Tablets 1,000 Adult Low Dose Enteric Coated Aspirin 81mg Tablets 300 Adult Low Dose Enteric Coated Aspirin 81mg Tablets 1,000

High

CPSCJan 26, 2022Nationwide• Geri-Care Pharmaceuticals, of Brooklyn, New York

Polymyxin B Injection (AuroMedics) – Particulate Contamination (2022)

Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot

Class IHigh

FDAJan 26, 2022Nationwide• AuroMedics Pharma LLC