Bio-Detek Recalls ZOLL Pro-padz Sterile Adult Electrodes Due to Sterility Concerns
Bio-Detek, Inc. is recalling ZOLL Pro-padz Sterile Adult Multi-Function Electrodes because product sterility is not assured. The recall affects 41 single units distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a risk-of-harm product (sterility not assured) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Bio-Detek, Inc. is recalling ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, part number 8900-4055-40. The recall is being conducted because product sterility is not assured. These disposable, single-use electrodes are intended for use in a sterile environment by trained medical professionals in connection with ZOLL Defibrillators for adult patients.
The affected product includes 41 single units from lot numbers 1614, 1914, and 2114. The products were distributed worldwide, including in the United States, Australia, Canada, Belgium, France, and Germany. The electrodes are used for defibrillation, cardioversion, external non-invasive pacing, and monitoring.
Healthcare facilities and consumers should stop using the affected electrodes and contact Bio-Detek, Inc. for further instructions or a return. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number: 8900-4055-40 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed thr
- Manufacturer
- Bio-Detek, Inc.
- Affected units
- 41
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Numbers: 1614
- 1914
- 2114
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Bio-Detek, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Bio-Detek, Inc.
See all →- SevereBio-Detek Recalls ZOLL Pro-padz Liquid Gel Radiolucent Electrodes
FDA (Devices) · 2019-07-10
- HighZoll Pro-padz Sterile Electrodes Recalled Due to Sterility Concerns
FDA (Devices) · 2014-10-15
- HighZOLL Pro-padz Sterile Adult Electrodes Recalled Due to Sterility Concerns
FDA (Devices) · 2014-10-15
- HighZOLL Pro-padz Sterile Electrodes Recalled Due to Sterility Concerns
FDA (Devices) · 2014-10-15
- HighZOLL Pro-padz Sterile Adult Electrodes Recalled for Sterility Assurance Issues
FDA (Devices) · 2014-09-24
Same hazard · sterility failure
See all →- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22