Penlon Delta Anesthetic Vaporizer Recalled for Manual Clarity Improvements
Penlon Ltd is recalling Delta Vaporizers to update the User Manual with clearer installation and pre-use check instructions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a documentation issue (unclear manual instructions) rather than a direct device defect or reported injury, fitting the 'Moderate' criteria for minor labeling/documentation issues.
Plain-English summary
Penlon Ltd is recalling the Delta Vaporizer, a medical device used to vaporize liquid anesthetic and deliver a controlled amount of vapor to patients. The recall was initiated after the manufacturer identified an instance where the installation and pre-use checks listed in the User Manual may not have been followed prior to clinical use.
To address this, Penlon Ltd has updated the Installation and daily Pre-Use Check sections of the User Manual to ensure the instructions are explicit and clear. The recall covers 9,208 units, of which 576 were distributed within the United States. Affected units are traced by serial numbers D0312-XXXX to D1112-XXXX.
The product was distributed worldwide, including in the US states of Florida, Kentucky, Pennsylvania, North Dakota, Minnesota, Illinois, New Jersey, Texas, Tennessee, and Virginia, as well as in several international locations. Users should refer to the updated User Manual for the revised instructions.
The recalled product
- 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.
- Manufacturer
- Penlon, Ltd.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All
- recalled products are traced by serial numbers D0312-XXXX to D1112-XXXX.
Distribution
Related recalls
Same hazard · documentation issue
See all →- LowHeartSine Defibrillators Recalled for Missing Maintenance Supplement
FDA (Devices) · 2026-10-07
- SevereBMC Medical Luna G3 APAP Devices Recalled for Retroactive Rework Reporting
FDA (Devices) · 2026-08-26
- LowFARASTAR Cardiac Ablation Generator Recall for Missing Catheter Information
FDA (Devices) · 2026-07-29
- ModerateFARASTAR Ablation Generator EU Medical Device Recall for Labeling Discrepancy
FDA (Devices) · 2026-07-29
- LowPenner bathing spa models recalled for lacking a unique device identifier
FDA (Devices) · 2026-03-18
Similar recalls
- HighVapor-Clean Anesthetic Filter Recalled Due to Manufacturing Leakage Defect
FDA (Devices) · 2023-05-24
- CriticalAtlan A350 anesthesia workstations recalled after mechanical ventilation failures were reported
FDA (Devices) · 2025-10-08
- HighGE Healthcare Recalls Tec 6 Anesthesia Vaporizers Due to Leak Detection Issue
FDA (Devices) · 2013-09-18
- ModerateGE Healthcare Recalls 28 Datex-Ohmeda TEC 7 Anesthesia Vaporizers
FDA (Devices) · 2018-04-04
- CriticalAtlan A350XL anesthesia workstations recalled after piston ventilator failures during use
FDA (Devices) · 2025-10-08
- HighDraeger D-Vapor Anesthesia Vaporizers Recalled for Anesthetic Agent Release
FDA (Devices) · 2016-06-01