RecallRadar

FDA Device recall Z-0292-2019

IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306

On 2018-11-07 the FDA classified a Class II recall of IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306 by Cmp Industries, citing foreign material in product.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0292-2019
ClassificationClass II
Statusterminated
Initiated2018-09-12
Published2018-11-07
Last updated2026-09-13 11:54 UTC
CompanyCmp Industries
DistributionUS

Product

IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards

Reason

Foreign material in product

Identifiers

code_infoLot Number: 85623 , 85827

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0292-2019%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.