Synaptive Medical Inc: Medical Device Recall in 2021 - (Recall #: Z-1955-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Synaptive Trackable Suction Set Standard and Malleable

Product Classification:

Class II

Date Initiated: April 23, 2021

Date Posted: July 7, 2021

Recall Number: Z-1955-2021

Event ID: 87937

Reason for Recall:

Due to visible burrs/metal filings affixed along the suction tube inner perimeter.

Status: Terminated

Product Quantity: 1291 units

Code Information:

Set and components codes: SYN-0657, SYN-0783 Consumables 3 Packs SYN-0663, SYN-0664, SYN-0665, SYN-0666, SYN-0667, SYN-0668, SYN-0759, SYN-0760, SYN-0761, SYN-0762, SYN-0763, SYN-0764, SYN-0765 and SYN-0766. Consumables Singles SYN- 0651, SYN-0652, SYN-0653, SYN-0654, SYN-0655, SYN-0656, SYN-0671,SYN-0672, SYN-0673, SYN-0674, SYN-0675, SYN-0676, SYN-0677 and SYN-0778. All lots and all serial numbers.

Distribution Pattern:

Domestic Distribution: IN, SC, MD, OR, TX ,LA, MI, NY, NV, FL, VA, CA,WI, PA and NC. International Distribution: Australia, Canada, Belgium, Netherlands, Singapore, Switzerland, Thailand, UK, Vietnam

Voluntary or Mandated:

Voluntary: Firm initiated