Bio-Detek, Inc.

FDA recalling firm · 4 enforcement events · 9 product records · 2013–2019 · RI

Bio-Detek, Inc. has 4 FDA enforcement events on this register (9 product records) between 2013 and 2019: 4 device; the busiest year was 2014 with 2.

0% of its events are Class I; the most common class is Class II (4). 0 events are listed as ongoing; the recalling firm's address is in RI.

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
28 May 2019	ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)	Device	Class II	1	Terminated
16 Sep 2014	ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO…	Device	Class II	4	Terminated
26 Aug 2014	ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per International/ National Standards, EN ISO 11137- 2:2012…	Device	Class II	3	Terminated
12 Mar 2013	Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15, 20, 500 and are indicated for Defibrillation, Cardioversion, Pacing, and Monitoring Part Number: 2033	Device	Class II	1	Terminated

By type and class

Device4

Class II4

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

Events by year

Enforcement events for Bio-Detek, Inc. by year initiated.

Questions and answers

How many FDA recalls has Bio-Detek, Inc. had?

4 enforcement events (9 product records) on this register, 2013–2019: 4 device.

Are any Bio-Detek, Inc. recalls ongoing?

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

What class are Bio-Detek, Inc. recalls?

4 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.