Smith & Nephew, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1041-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious materials. Used for chronic, acute, traumatic, subacute, and dehisced wounds/ulcers/partial thickness burns/flaps/grafts.

Product Classification:

Class II

Date Initiated: November 11, 2016

Date Posted: January 25, 2017

Recall Number: Z-1041-2017

Event ID: 75966

Reason for Recall:

Lack of 510k clearance for design modification.

Status: Ongoing

Product Quantity: 15,960 units in the US

Code Information:

Model No. 66800164; All pumps of this model are affected.

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated