The Recall Desk

Manufacturer

Bayer Healthcare

6 recalls in our database name Bayer Healthcare as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
1
Most recent
2017-02-15

Of the 6 recalls from Bayer Healthcare we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (17%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–6 of 6

  • HighFDA (Devices)·Z-0927-2017·2017-02-15

    Bayer Recalls Medrad Intego PET Infusion System Pumps

    Bayer is recalling Medrad Intego PET Infusion System pumps because the administration sets may produce particulates in radiopharmaceutical vials.

    Product
    MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures. It is also intended to provide effective rad
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0400-2017·2016-11-23

    Bayer Medrad Intego PET Infusion Pump Recall for Pressure Testing Failure

    Bayer Healthcare is recalling PET Infusion Pumps used with the Medrad Intego system because they may fail pressure testing specifications when more than one year past the manufacturing date.

    Product
    PET Infusion Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2768-2016·2016-09-14

    Bayer Certegra Workstation Recalled for Fire and Smoke Risk

    Bayer Healthcare is recalling 165 Certegra Workstations used with Medrad Stellant CT Injection Systems because they may produce smoke and sparks of fire.

    Product
    Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial Numbers The Medrad Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2244-2016·2016-07-27

    Bayer Recalls MEDRAD MRXperion MRI Injection Systems Due to Error Messages

    Bayer Healthcare is recalling 42 MEDRAD MRXperion MR Injection Systems because they display a 4205 error message when used with 3T scanners.

    Product
    Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit Usage: The MEDRAD MRXperion MR Injection System is a syringe based fluid delivery system indicated for delivery of contrast media and saline during MR applicat
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0627-2016·2016-01-20

    Bayer Recalls Medrad Source Administration Sets for Dosing Errors

    Bayer Healthcare is recalling Medrad Source Administration Sets because tubing defects may cause incorrect dose positioning during nuclear medicine procedures.

    Product
    Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2775-2015·2015-09-23

    Bayer Medrad Mark 7 Arterion Injection System Software Recall

    Bayer Healthcare is recalling 71 Medrad Mark 7 Arterion Injection Systems due to a software defect that removes purge enforcement, potentially affecting angiographic studies.

    Product
    Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Bayer HealthCare

company

Country
Germany
Founded
2003

Official website

Source: Wikidata (Q812134), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.