CLASS II ONGOING Device recall · Reported 6 Mar 2024 · FDA Enforcement Report
Tensive Conductive Adhesive Gel, Product recalled by Parker Laboratories
Parker Laboratories is recalling Tensive Conductive Adhesive Gel, Product, distributed in 10 states. The recall was initiated on 22 Jan 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1204-2024
- FDA event ID
- 93891
- Recalling firm
- Parker Laboratories, Fairfield, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Jan 2024
- FDA classified
- 29 Feb 2024
- Reported
- 6 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 22 Jan 2024 | Recall initiated by company | |
| 29 Feb 2024 | Classified by FDA | +38 days |
| 6 Mar 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.
Where it was distributed
US (Domestic): AZ, CA, FL, NC, NJ, NV, NY, PA, WA, WI. OUS (Foreign): Canada, France and Germany.
ArizonaCaliforniaFloridaNorth CarolinaNew JerseyNevadaNew YorkPennsylvaniaWashingtonWisconsin
Questions about this recall
Why was it recalled?
Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60.
Which lots are affected?
Product Number: 22-60; UDI/DI: (Master)20855683006337, (Inner Box) 10855683006330, (Individual Unit) 00855683006333; Lot A0623009.
Where was it sold?
US (Domestic): AZ, CA, FL, NC, NJ, NV, NY, PA, WA, WI. OUS (Foreign): Canada, France and Germany.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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