American Surgical Company: Medical Device Recall in 2016 - (Recall #: Z-1738-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

American Surgical Ultracot 5 mm x 13 mm (Glassine) Ref Number: 23-02G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Product Classification:

Class II

Date Initiated: March 31, 2016

Date Posted: June 1, 2016

Recall Number: Z-1738-2016

Event ID: 73734

Reason for Recall:

Product packaging defective compromising sterility

Status: Terminated

Product Quantity: 15 boxes

Code Information:

Lot numbers: 2015/09 AY 2015/11 AA 2015/12 BB

Distribution Pattern:

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated