Bayer Healthcare

FDA recalling firm · 6 enforcement events · 6 product records · 2015–2016 · PA

Bayer Healthcare has 6 FDA enforcement events on this register (6 product records) between 2015 and 2016: 6 device; the busiest year was 2016 with 4.

0% of its events are Class I; the most common class is Class II (6). 0 events are listed as ongoing; the recalling firm's address is in PA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
7 Nov 2016	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 radiation shielding to medical personnel…	Device	Class II	1	Terminated
30 Sep 2016	PET Infusion Pump	Device	Class II	1	Terminated
2 Aug 2016	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 studies in computed tomography (CT) applications	Device	Class II	1	Terminated
9 Jun 2016	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 applications. It is intended to be used for the…	Device	Class II	1	Terminated
30 Nov 2015	Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.	Device	Class II	1	Terminated
4 Aug 2015	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.	Device	Class II	1	Terminated

By type and class

Device6

Class II6

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Bayer Healthcare by year initiated.

Questions and answers

How many FDA recalls has Bayer Healthcare had?

6 enforcement events (6 product records) on this register, 2015–2016: 6 device.

Are any Bayer Healthcare recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Bayer Healthcare recalls?

6 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.