Bio-Detek recalls

Bio-Detek has 9 recalls on record with the FDA and USDA, the earliest in 2014 and the latest reported on 10 Jul 2019. The most frequent reason is sterility.

Total recalls9since 2014

Last 12 months0reported

Class I00% of total

Ongoing0latest 10 Jul 2019

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 9 100%Class III 0 0%

Why bio-detek is recalled

Sterility778%
Other Reasons222%

Product types

Pacemakers & Defibrillators889%
Other Medical Devices111%

By year

2019111%
2014889%

All bio-detek recalls, newest first

9 total

Reported	Class	Recall	Company	Reason	Where
10 Jul 2019Device	CLASS II	ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers recalled by Bio-Detek	Bio-Detek	Other	Nationwide
15 Oct 2014Device	CLASS II	ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single recalled	Bio-Detek	Sterility	Nationwide
15 Oct 2014Device	CLASS II	ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) recalled	Bio-Detek	Sterility	Nationwide
15 Oct 2014Device	CLASS II	ZOLL Pro-padz Sterile Adult Multi-Function Electrodes recalled	Bio-Detek	Sterility	Nationwide
15 Oct 2014Device	CLASS II	ZOLL Pro-padz Sterile Adult Multi-Function Electrodes recalled	Bio-Detek	Sterility	Nationwide
24 Sep 2014Device	CLASS II	ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) recalled	Bio-Detek	Sterility	Nationwide
24 Sep 2014Device	CLASS II	ZOLL Pro-padz Sterile Adult Multi-Function Electrodes recalled	Bio-Detek	Sterility	Nationwide
24 Sep 2014Device	CLASS II	ZOLL Pro-padz Sterile Adult Multi-Function Electrodes recalled	Bio-Detek	Sterility	Nationwide
10 Sep 2014Device	CLASS II	Medsolutions4U Multi-Function Electrodes to be used recalled	Bio-Detek	Other	RI

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.