Bayer Medical Care, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2962-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765

Product Classification:

Class II

Date Initiated: June 28, 2018

Date Posted: September 12, 2018

Recall Number: Z-2962-2018

Event ID: 80727

Reason for Recall:

The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the bolts. The overtightening of bolts may compromise the structural integrity of the system which could lead to the OCS disengaging from the ceiling mount and this may cause injury to the patient or the operator.

Status: Terminated

Product Quantity: 4

Code Information:

Serial Numbers: 917/21956, 516/21035, 817/21916, 817/21910

Distribution Pattern:

The devices were distributed to the following US states: OH, TX, and WV.

Voluntary or Mandated:

Voluntary: Firm initiated