Penlon, Ltd.: Medical Device Recall in 2013 - (Recall #: Z-1653-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.

Product Classification:

Class II

Date Initiated: May 14, 2013

Date Posted: July 10, 2013

Recall Number: Z-1653-2013

Event ID: 65286

Reason for Recall:

It has come to Penlon Ltd's attention of an instance where the installation and pre-use checks listed in the User Manual may not have been followed prior to the clinical use of the vaporizer. Penlon Ltd has updated the Installation and daily Pre-Use Check sections of the User Manual to ensure that the instructions are explicit and clear.

Status: Terminated

Product Quantity: 9208 (of which 576 were within the US)

Code Information:

All; recalled products are traced by serial numbers D0312-XXXX to D1112-XXXX.

Distribution Pattern:

Worldwide Distribution - USA including FL, KY, PA, ND, MN, IL, NJ, TX, TN, and VA. Internationally to Belgium, China, Czech Republic, France, Germany, Switzerland, Australia, Finland, Holland, Lithunia, Malta, Poland, and Slovakia.

Voluntary or Mandated:

Voluntary: Firm initiated