Medivators, Inc.

FDA recalling firm · 3 enforcement events · 9 product records · 2015–2021 · MN

Medivators, Inc. has 3 FDA enforcement events on this register (9 product records) between 2015 and 2021: 3 device; the busiest year was 2015 with 1.

0% of its events are Class I; the most common class is Class II (3). 0 events are listed as ongoing; the recalling firm's address is in MN.

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
20 Apr 2021	Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.	Device	Class II	1	Terminated
9 Oct 2019	Medivators Endo Smartcap Endoscope Tubing. REF100145. Packaged as Contents 1, 10, 50, and found in BMP-C145. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes. Sterile EO - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply…	Device	Class II	7	Terminated
3 Aug 2015	Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is employed.	Device	Class II	1	Terminated

By type and class

Device3

Class II3

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

Events by year

Enforcement events for Medivators, Inc. by year initiated.

Questions and answers

How many FDA recalls has Medivators, Inc. had?

3 enforcement events (9 product records) on this register, 2015–2021: 3 device.

Are any Medivators, Inc. recalls ongoing?

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

What class are Medivators, Inc. recalls?

3 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.