Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported March 27, 2013
Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation installed with the CAS I/II Absorber. Anesthesia workstation for use in the hospital environment and locations not requiring portability.
A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may cause a condition leading to an increase in the carbon dioxide concentration within th…
Del Mar Reynolds Medical, Ltd. recalled Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CA… - a critical-severity action.
Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CA… was recalled by Del Mar Reynolds Medical, Ltd. in March 27, 2013. Reason: A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may cause a conditio…. Check the official notice for the remedy. Verify recall #Z-0968-2013 with the FDA Devices before acting.
The recall
Del Mar Reynolds Medical, Ltd. issued this critical-severity FDA Devices recall-A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may cause a conditio….
- Critical
- severity level
- Class I
- classification
- March 27, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0968-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0968-2013) was formally reported on March 27, 2013, with the manufacturer initiating the action on January 15, 2013. It is classified under Critical severity (Class I), with a current status of Terminated. Del Mar Reynolds Medical, Ltd. is listed as the recalling firm, operating out of Hertford, N/A. Federal records list the affected scope as 108 total (17 units in the US and 91 units outside the US).
The documented reason for this recall is: A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may cause a condition leading to an increase in the carbon dioxide concentration within the inspired gas being delivered to the pa… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA Nationwide including the states of New Mexico, North Carolina and the countries of Argentina, China, Mexico, and Taiwan.. 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 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
108 total (17 units in the US and 91 units outside the US)
Related Recalls
6
3 from same agency
Product description
Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation installed with the CAS I/II Absorber. Anesthesia workstation for use in the hospital environment and locations not requiring portability.
Reason for recall
A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may cause a condition leading to an increase in the carbon dioxide concentration within the inspired gas being delivered to the patient.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0968-2013 |
| Date reported | March 27, 2013 |
| Date initiated | January 15, 2013 |
| Recalling firm | Del Mar Reynolds Medical, Ltd. |
| Firm location | Hertford, N/A |
| Affected scope | 108 total (17 units in the US and 91 units outside the US) |
| Distribution | Worldwide Distribution - USA Nationwide including the states of New Mexico, North Carolina and the countries of Argentina, China, Mexico, and Taiwan. |
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-0968-2013) 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.
- 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? ▼
Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation installed with the CAS I/II Absorber. Anesthesia workstation for use in the hospital environment and locations not requiring portability.. Recalled by Del Mar Reynolds Medical, Ltd.. Units affected: 108 total (17 units in the US and 91 units outside the US).
Why was this product recalled? ▼
A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may cause a condition leading to an increase in the carbon dioxide concentration within the inspired gas being delivered to the patient.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 27, 2013. Severity: Critical. Recall number: Z-0968-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA Nationwide including the states of New Mexico, North Carolina and the countries of Argentina, China, Mexico, and Taiwan..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0968-2013) 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.
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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 March 27, 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.