Class II — Penlon, Ltd.
| Recalling firm | PENLON LTD. |
|---|---|
| Registered facility | PENLON LTD. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 9208 (of which 576 were within the US) |
| Distribution | 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. |
| Initiated | 2013-05-14 |
| Classified | 2013-07-02 |
| Terminated | 2014-05-12 |
| Recall number | Z-1653-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Penlon, Ltd. (Z-1653-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65286/
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