Data Foundry

Medical device recalls 2013

Delta Vaporizer An anesthetic vaporizer is a device used to vaporize… — Class II medical device recall Z-1653-2013

Terminated recall by Penlon, Ltd., reported 2013-07-10, distributed in FL, IL, KY, MN, ND, NJ, PA, TN…. It has come to Penlon Ltd's attention of an instance where the installation and pre-use checks listed in the U

Recall numberZ-1653-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmPenlon, Ltd., Abingdon, N/A, United Kingdom
Recall initiated2013-05-14
Classified2013-07-02
Reported by FDA2013-07-10
Terminated2014-05-12
DistributedFL, IL, KY, MN, ND, NJ, PA, TN, TX, VA
Countries outside the USAU, BE, CH, CN, CZ, DE, FI, FR, MT, NL, PL, SK
Serial numbersD0312-XXXX, D1112-XXXX

Product

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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1653-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.