RecallRadar

FDA Device recall Z-2797-2015

Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures

On 2015-09-30 the FDA classified a Class II recall of Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures by Bien Air Dental, citing possible loosening of the dental tool, which may lead to potential swallowing of the tool.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2797-2015
ClassificationClass II
Statusterminated
Initiated2015-08-27
Published2015-09-30
Last updated2026-09-13 11:53 UTC
CompanyBien Air Dental
DistributionFL

Product

Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures

Reason

Possible loosening of the dental tool, which may lead to potential swallowing of the tool.

Identifiers

code_info
Catalog numbers: 1600939-001 and 1600938-001 Serial numbers concerned: - Ref: 1600939-001: Serial numbers included in…Catalog numbers: 1600939-001 and 1600938-001 Serial numbers concerned: - Ref: 1600939-001: Serial numbers included in the following range: 15B0001 up to 15F0011 - Ref: 1600938-001: Serial numbers included in the following range: 15B0007 up to 15F0027

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-2797-2015%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.