Indianola, PA, United States
Bayer Medical Care, Inc. recalls
8 recalls recorded since 2018, most recently on 31 July 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls8
Ongoing (FDA)3
Terminated or completed5
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 31 July 2026
- Reason
- Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3147-2026
- MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Ongoing Class II Medical devices
- Recall started
- 24 April 2026
- Reason
- Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the CFCV snap interface. In instances where engagement is achieved through applied force, the connection is unstable, and the stopcock may disengage before or during contrast injection, leading to procedure interruption.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DE, FL, IA, IL, IN, KS, KY, LA, MA, MD, ME, MO, NC, NY, OH, OK, PA, SC, TN, TX, VA, WI and the countries of AE, BA, BE, CA, CH, CN, DE, DK, ES, FR, GB, HK, HR, IL, KW, MT, MX, NL, RO, RU, SE, ZA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2296-2026
- Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad¿ Avanta Injection System; Catalog number: AVA 500 MPAT (Part 2 of 2); Affected material numbers: 87629007, 60729458, 86566
Ongoing Class II Medical devices
- Recall started
- 30 November 2022
- Reason
- Black specks may be present on the packaged needles
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, IN, MN, NY, OH, TX, VA and the country of China.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0910-2023
- Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number: 86566621 Intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG)
Terminated Class II Medical devices
- Recall started
- 14 September 2021
- Terminated
- 19 January 2023
- Reason
- Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR)
- Distribution
- Worldwide distribution - US Nationwide and the countries of AU, BY, DE, DK, GB, HR, NL, NZ, RU, SE, TH.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0199-2022
- The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an accessory to the MEDRAD Mark 7 Arterion Injection System. It is designed to be loaded i
Terminated Class II Medical devices
- Recall started
- 5 October 2020
- Terminated
- 19 March 2021
- Reason
- Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe.
- Distribution
- Distributed to healthcare facilities nationwide throughout the US.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0483-2021
- Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number: FLEXD-150-SCS Description: 2 - 150 mL FLEX syringes, 1 large saline spike, 1 small contrast spike, patient t-con
Terminated Class II Medical devices
- Recall started
- 14 December 2018
- Terminated
- 16 June 2020
- Reason
- If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall.
- Distribution
- The products were distributed US nationwide. The products were distributed to the following foreign countries: Algeria, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Brunei Darussalam, Canada, Chile, China, Cote D'Ivoire, Cuba, Curacao, Cyprus, Czech Republic, Denma
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0745-2019
- MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Injection System, or Medrad Mark V ProVis In
Terminated Class II Medical devices
- Recall started
- 7 September 2018
- Terminated
- 11 July 2019
- Reason
- Bayer has received reports of loose particulate in the filter when the dust cap is removed. Bayer conducted further testing confirming the dust cap may generate particulate which may potentially enter the fluid path.
- Distribution
- Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, and WI. Foreign countries: UAE, Austria, Australia, Bosnia and Herzegovina, Belgium, Bahra
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0097-2019
- Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems Product Usage: 1.2 micron filter for use with Intravenous Administration Sets
Terminated Class II Medical devices
- Recall started
- 28 June 2018
- Terminated
- 26 November 2018
- Reason
- The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the bolts. The overtightening of bolts may compromise the structural integrity of the system which could lead to the OCS disengaging from the ceiling mount and this may cause injury to the patient or the operator.
- Distribution
- The devices were distributed to the following US states: OH, TX, and WV.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2961-2018, Z-2962-2018, Z-2960-2018
- Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injector systems as a support for an injector head. , SHORT CEIL MNT, STD HORZ ARM, Catalog # OCS 115AS, Material Number 59880288
- Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765
- Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.