Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported December 31, 2025
Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.
A certain component of affected devices was not delivered within specification and contained impurities.
Draeger, Inc. recalled Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer. — a critical-severity action.
Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer. was recalled by Draeger, Inc. in December 31, 2025. Reason: A certain component of affected devices was not delivered within specification and contained impurities.. Check the official notice for the remedy. Verify recall #Z-0934-2026 with the FDA Devices before acting.
The recall
Draeger, Inc. issued this critical-severity FDA Devices recall — A certain component of affected devices was not delivered within specification and contained impurities..
- Critical
- severity level
- 188 units
- affected scope
- Class I
- classification
- December 31, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0934-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0934-2026) was formally reported on December 31, 2025, with the manufacturer initiating the action on November 24, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. Draeger, Inc. is listed as the recalling firm, operating out of Telford, PA. Federal records list the affected scope as 188 units.
The documented reason for this recall is: A certain component of affected devices was not delivered within specification and contained impurities. Distribution data in the federal record shows the product reached: Worldwide - US Nationwide distribution in the states of AK, CA, FL, IA, KS, MD, ME, MN, NY, OH, PA, RI, SD, TN, TX, UT, W and the countries of Argentina, Australia, Belgium, Brazil, Cambodia, China, Columbia, Czech Repu…. 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, 6 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 — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
188 units
Related Recalls
6
6 from same agency
Product description
Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.
Reason for recall
A certain component of affected devices was not delivered within specification and contained impurities.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0934-2026 |
| Date reported | December 31, 2025 |
| Date initiated | November 24, 2025 |
| Recalling firm | Draeger, Inc. |
| Firm location | Telford, PA |
| Affected scope | 188 units |
| Distribution | Worldwide - US Nationwide distribution in the states of AK, CA, FL, IA, KS, MD, ME, MN, NY, OH, PA, RI, SD, TN, TX, UT, W and the countries of Argentina, Australia, Belgium, Brazil, Cambodia, China, Columbia, Czech Republic, Ecuador, Egypt… |
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-0934-2026) 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.
- This is a Class I (high-risk) recall — stop using the product immediately and follow the disposal or return instructions. 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? ▼
Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.. Recalled by Draeger, Inc.. Units affected: 188 units.
Why was this product recalled? ▼
A certain component of affected devices was not delivered within specification and contained impurities.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 31, 2025. Severity: Critical. Recall number: Z-0934-2026.
Where was the recalled product distributed? ▼
Distribution: Worldwide - US Nationwide distribution in the states of AK, CA, FL, IA, KS, MD, ME, MN, NY, OH, PA, RI, SD, TN, TX, UT, W and the countries of Argentina, Australia, Belgium, Brazil, Cambodia, China, Columbia, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Hungary, Indonesia, Israel, Japan, Kenya, Mexico, Nepal, Norway, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Serbia, Singapore, Spain, Thailand, Turkey, United Kingdom, United Arab Emirates, Vietnam..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0934-2026) 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.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported December 31, 2025.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. 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 June 2026.