Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 10, 2013
Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.
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 th…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Penlon, Ltd. recalled Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic… - a moderate-severity action.
Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic… was recalled by Penlon, Ltd. in July 10, 2013. Reason: It has come to Penlon Ltd's attention of an instance where the installation and pre-use checks listed in the …. Check the official notice for the remedy. Verify recall #Z-1653-2013 with the FDA Devices before acting.
The recall
Penlon, Ltd. issued this moderate-severity FDA Devices recall-It has come to Penlon Ltd's attention of an instance where the installation and pre-use checks listed in the ….
- Moderate
- severity level
- Class II
- classification
- July 10, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1653-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1653-2013) was formally reported on July 10, 2013, with the manufacturer initiating the action on May 14, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Penlon, Ltd. is listed as the recalling firm, operating out of Abingdon, N/A. Federal records list the affected scope as 9208 (of which 576 were within the US).
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: 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,…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
9208 (of which 576 were within the US)
Related Recalls
6
3 from same agency
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1653-2013 |
| Date reported | July 10, 2013 |
| Date initiated | May 14, 2013 |
| Recalling firm | Penlon, Ltd. |
| Firm location | Abingdon, N/A |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1653-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.. Recalled by Penlon, Ltd.. Units affected: 9208 (of which 576 were within the US).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 10, 2013. Severity: Moderate. Recall number: Z-1653-2013.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1653-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 10, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.