Bien Air Dental SA: Medical Device Recall in 2015 - (Recall #: Z-2797-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 27, 2015

Date Posted: September 30, 2015

Recall Number: Z-2797-2015

Event ID: 72079

Reason for Recall:

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

Status: Terminated

Product Quantity: 112 (U.S.)

Code Information:

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

Distribution Pattern:

Worldwide Distribution - US distribution to one distributor in FL.

Voluntary or Mandated:

Voluntary: Firm initiated