FDA Device recall Z-0425-2015

Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity

FDA Device
Class II
terminated
Published 2014-12-03

On 2014-12-03 the FDA classified a Class II recall of Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity by Discus Dental, citing product sold after April 1, 2014 were inadvertently filled with hydrogen peroxide teeth whitening gel (6% concentration as dispensed) on one side of the dual barrel syringe instea….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0425-2015
Classification	Class II
Status	terminated
Initiated	2014-10-24
Published	2014-12-03
Last updated	2026-09-13 11:53 UTC
Company	Discus Dental
Distribution	US

Product

Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syringe, 4 packs, 6 packs and in teeth whitening kits

Reason

Product sold after April 1, 2014 were inadvertently filled with hydrogen peroxide teeth whitening gel (6% concentration as dispensed) on one side of the dual barrel syringe instead of the intended component (phosphate gel). Consequently, use of this product by patients may result in a neutral effect or increased sensitivity.

Identifiers

code_info	- List of Relief ACP Oral Care Gel products distributed in U.S. SKU Number Lot Number PV1602 14111008 P… - List of Relief ACP Oral Care Gel products distributed in U.S. SKU Number Lot Number PV1602 14111008 PV1602 14127009 PV1609 14141018 - List of Teeth Whitening kits containing Relief ACP Oral Care Gel products distributed in U.S. SKU Number Lot Number ZM2665 14090044 ZM2665 14097026 ZM2665 14104024 ZM2665 14106004 ZM2665 14113035 ZM2665 14121018 ZM2665 14122005 ZM2665 14134020 ZM2666 14104025 ZM2666 14105025 ZM2666 14113028 ZM2666 14118015 ZM2666 14127019 ZM2666 14134030 ZM2666 14139005 DSH1001 14113006 DHS1001 14127007 List of Teeth Whitening kits containing Relief ACP Oral Care Gel products distributed outside of U.S.: SKU Number Lot Number ZME2665 14143017 ZME2665 14143024 ZME2631

code_info

- List of Relief ACP Oral Care Gel products distributed in U.S. SKU Number Lot Number PV1602 14111008 P…

- List of Relief ACP Oral Care Gel products distributed in U.S. SKU Number Lot Number PV1602 14111008 PV1602 14127009 PV1609 14141018 - List of Teeth Whitening kits containing Relief ACP Oral Care Gel products distributed in U.S. SKU Number Lot Number ZM2665 14090044 ZM2665 14097026 ZM2665 14104024 ZM2665 14106004 ZM2665 14113035 ZM2665 14121018 ZM2665 14122005 ZM2665 14134020 ZM2666 14104025 ZM2666 14105025 ZM2666 14113028 ZM2666 14118015 ZM2666 14127019 ZM2666 14134030 ZM2666 14139005 DSH1001 14113006 DHS1001 14127007 List of Teeth Whitening kits containing Relief ACP Oral Care Gel products distributed outside of U.S.: SKU Number Lot Number ZME2665 14143017 ZME2665 14143024 ZME2631

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0425-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.