Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 10, 2016
Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest population of patients on the Astral device is COPD patients primarily using the device at night with some daytime use for recovery breathing. While it is possible that there may be scenarios where critically dependent patients may encounter this scenario, the likelihood of this leading to harm is negligible because critically dependent patients will have
Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Resmed Corporation recalled Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non… - a moderate-severity action.
Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non… was recalled by Resmed Corporation in February 10, 2016. Reason: Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue.. Check the official notice for the remedy. Verify recall #Z-0746-2016 with the FDA Devices before acting.
The recall
Resmed Corporation issued this moderate-severity FDA Devices recall-Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue..
- Moderate
- severity level
- 15K units
- affected scope
- Class II
- classification
- February 10, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0746-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0746-2016) was formally reported on February 10, 2016, with the manufacturer initiating the action on January 13, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Resmed Corporation is listed as the recalling firm, operating out of San Diego, CA. Federal records list the affected scope as 14,736.
The documented reason for this recall is: Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue. Distribution data in the federal record shows the product reached: Worldwide Distribution - US including VA, FL, MO, CA, LA, TX, NJ, NH, NC, WV, MI, ID, OK, MI, MN, UT, CT, IL, AZ, UT, KY, MT, PA, RI, TN, DE, NE, LA, NY, SC, WY, IN, VA, GA, CO and Internationally to CA, CO, and AR.. 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
14,736
Related Recalls
6
3 from same agency
Product description
Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest population of patients on the Astral device is COPD patients primarily using the device at night with some daytime use for recovery breathing. While it is possible that there may be scenarios where critically dependent patients may encounter this scenario, the likelihood of this leading to harm is negligible because critically dependent patients will have a form of backup ventilation as standard of care.
Reason for recall
Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0746-2016 |
| Date reported | February 10, 2016 |
| Date initiated | January 13, 2016 |
| Recalling firm | Resmed Corporation |
| Firm location | San Diego, CA |
| Affected scope | 14,736 |
| Distribution | Worldwide Distribution - US including VA, FL, MO, CA, LA, TX, NJ, NH, NC, WV, MI, ID, OK, MI, MN, UT, CT, IL, AZ, UT, KY, MT, PA, RI, TN, DE, NE, LA, NY, SC, WY, IN, VA, GA, CO and Internationally to CA, CO, and AR. |
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-0746-2016) 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? ▼
Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest population of patients on the Astral device is COPD patients primarily using the device at night with some daytime use for recovery breathing. While it is possible that there may be scenarios where critically dependent patients may encounter this scenario, the likelihood of this leading to harm is negligible because critically dependent patients will have a form of backup ventilation as standard of care.. Recalled by Resmed Corporation. Units affected: 14,736.
Why was this product recalled? ▼
Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 10, 2016. Severity: Moderate. Recall number: Z-0746-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US including VA, FL, MO, CA, LA, TX, NJ, NH, NC, WV, MI, ID, OK, MI, MN, UT, CT, IL, AZ, UT, KY, MT, PA, RI, TN, DE, NE, LA, NY, SC, WY, IN, VA, GA, CO and Internationally to CA, CO, and AR..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0746-2016) 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 February 10, 2016. 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.