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Bayer Healthcare Recalls
11 recalls on record · July 25, 2012 to February 15, 2017 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 15, 2017Medical DevicesFDA
Bayer Healthcare recalls MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride
Hazard: Bayer has determined that all current Source Administration Sets (SAS) used with the Medrad Intego Pet Infusion System may produce particulates in radiopharmaceutical (RP) vials when the needle is inserted.
November 23, 2016Medical DevicesFDA
Bayer Healthcare recalls PET Infusion Pump
Hazard: The Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System do not meet pressure testing specifications in an occlusion situation when the product is more than one year past manufacturing date.
September 14, 2016Medical DevicesFDA
Bayer Healthcare recalls Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Seria
Hazard: CertegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exhibit thermal events, such as: smoke and sparks of fire.
July 27, 2016Medical DevicesFDA
Bayer Healthcare recalls Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit
Hazard: Bayer Healthcare is initiating this recall due to complaints that were received from customer sites describing a 4205 error message when the injector is used with a 3T scanner.
January 20, 2016Medical DevicesFDA
Bayer Healthcare recalls Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuc
Hazard: The firm's investigation of the Medrad Intego indicates that the inner diameter of the saline tubing is out of specification and may result in the system failing to position the dose correctly during extraction, potentially leading to a low measurement of the extracted dose or to a higher dose being extracted. The occluded SAS tubing may impair the priming function and prompt an RP prime fail
September 23, 2015Medical DevicesFDA
Bayer Healthcare recalls Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be use
Hazard: Software Version SW 005.006_SH, resulted in the removal of purge enforcement from traditional New-Case, Power Up and Syringe Change use cases while the injector head is in the upright position.
September 9, 2015Medical DevicesFDA
Bayer Healthcare, LLC recalls Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control solution. Plastic bot
Hazard: If the control solution bottle is not thoroughly shaken prior to use, the control test result may be higher than the control range and may not be recognized and marked as a control test by the blood glucose meter. Also, the control solution, used as a quality control test in blood glucose meter systems, may read outside the specified range too high or too low.
November 13, 2013Medical DevicesFDA
Bayer Healthcare Llc recalls Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated He
Hazard: Test results from these lots may produce a high-bias reading (by up to 20%) that is outside of limits defined for stability and product accuracy when product is stored at room temperature four (4) to five (5) months after release.
March 6, 2013DrugsFDA
Bayer Healthcare, LLC recalls Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400 mg/Expectorant, a) 24 coated caple
Hazard: Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label.
July 25, 2012DrugsFDA
Bayer Healthcare, LLC recalls Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a) 16 ct. blister (NDC 0280-8005-16), b)24 ct
Hazard: Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton.
July 25, 2012DrugsFDA
Bayer Healthcare, LLC recalls Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, Distributed by Bayer Health C
Hazard: Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton.