Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported May 16, 2018
AirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing 6/cs Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/un…
Vyaire Medical recalled AirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing 6/cs Product Usag… - a critical-severity action.
AirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing 6/cs Product Usag… was recalled by Vyaire Medical in May 16, 2018. Reason: The mask component on various lots of the resuscitation devices have been identified as having the potential…. Check the official notice for the remedy. Verify recall #Z-1552-2018 with the FDA Devices before acting.
The recall
Vyaire Medical issued this critical-severity FDA Devices recall-The mask component on various lots of the resuscitation devices have been identified as having the potential….
- Critical
- severity level
- 305K units
- affected scope
- Class I
- classification
- May 16, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1552-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1552-2018) was formally reported on May 16, 2018, with the manufacturer initiating the action on April 27, 2017. It is classified under Critical severity (Class I), with a current status of Terminated. Vyaire Medical is listed as the recalling firm, operating out of Vernon Hills, IL. Federal records list the affected scope as 305,136 units, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mas… Distribution data in the federal record shows the product reached: Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.. 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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
305,136 units
Related Recalls
6
6 from same agency
Product description
AirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing 6/cs Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
Reason for recall
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1552-2018 |
| Date reported | May 16, 2018 |
| Date initiated | April 27, 2017 |
| Recalling firm | Vyaire Medical |
| Firm location | Vernon Hills, IL |
| Affected scope | 305,136 units |
| Distribution | Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe. |
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-1552-2018) 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? ▼
AirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing 6/cs Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.. Recalled by Vyaire Medical. Units affected: 305,136 units.
Why was this product recalled? ▼
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 16, 2018. Severity: Critical. Recall number: Z-1552-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1552-2018) 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.
Nationwide recalls with similar severity or category timing
Two federal-filing-derived peer sets for this notice, both outside the same recalling firm and filing state so the neighborhoods are not firm or geographic containment.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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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 May 16, 2018. 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 August 2026.