FDA Medical Device Recalls (openFDA)
Bio-Signal Group Corp.: HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrodes.
- Recall number
- Z-0705-2020
- Recalling firm
- Bio-Signal Group Corp.
- Product
- HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrodes.
- Status
- Terminated
- Initiated
- 2019-10-29
- Posted
- 2019-12-18
- Terminated
- 2021-09-07
- Reason
- Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)
- Root cause
- Process control
- Action
- Bio-Signal issued Email notification on 10/29/2019 advising reason for recall, health risk and action to take: Distributors - Actions to be taken: 1)Please immediately cease distribution of the affected product. 2)Please examine your inventory for the affected product, quarantine the affected product and complete the attached response form to Bio-Signal Group by email to: recall@biosignalgroup.com 3)If you have further distributed this product to: "Domestic customers: please notify your customers at once and request that they contact Bio-Signal Group directly at 978-429-8756 (Monday Friday, 8:30 AM to 5:00 PM EDT) or by email at recall@biosignalgroup.com for further instructions. "International customers: please notify your customers at once and request that they quarantine and dispose the affected product and respond with the attached response to yourself. You can elect to send them replacements or credit. Customers - Actions to be taken: 1)Please immediately cease use of the affected product lot numbers in the above table. 2) If you still have any of the affected lots in your inventory, we are requesting that you immediately quarantine those products and return them to Bio-Signal Group. If you will not return any product please inform Bio-Signal Group that there are none to return. 3) To initiate return of product, please fill out the attached response form and send to Bio-Signal Group by email to: recall@biosignalgroup.com, and we will provide you with a return authorization code and return shipping labels. Our customer representative number is 978-429-8756. EXPANDED RECALL: Biosignal initated telephone calls, emails on 12/31/9 with consignees on to quarantine inventory of the following: 1710-03 4oz tubes with 3 tubes in each box, lot 31160 and 1700-24 Single use cups in boxes of 24 cups, lot numbers: 31320, 31365. A formal Recall Amended Urgent Medical Device Notification issued to customers on 2/xx/20 stating background of recall and r
- Quantity
- 45,375 individual cups Expanded:1314 boxes (24/box)
- Distribution
- US Nationwide distribution in the states of CA, KY, MA, NM, PA, WI.
- Lot, serial or model codes
- Lot # s 29879, 29958, 30656 Expanded: Lot # 31320 and Lot #31365
- 510(k) numbers
- ["K970694"]
- PMA numbers
- not on file
- Product code
- KOY
- Firm FEI
- 3006315274
- Firm city
- Acton
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28