Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported October 21, 2020
Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it can be used for low end to high end intensive care, in different configurations. It supports a variety of breathing modes and can be used for Neonates, Pediatric and Adults.
A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb Nebulizer module to the Servo-i device successfully.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Getinge Group Logistics America, LLC recalled Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended f… - a moderate-severity action.
Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended f… was recalled by Getinge Group Logistics America, LLC in October 21, 2020. Reason: A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb N…. Check the official notice for the remedy. Verify recall #Z-0092-2021 with the FDA Devices before acting.
The recall
Getinge Group Logistics America, LLC issued this moderate-severity FDA Devices recall-A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb N….
- Moderate
- severity level
- 431 units
- affected scope
- Class II
- classification
- October 21, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0092-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0092-2021) was formally reported on October 21, 2020, with the manufacturer initiating the action on September 17, 2020. It is classified under Moderate severity (Class II), with a current status of Ongoing. Getinge Group Logistics America, LLC is listed as the recalling firm, operating out of Wayne, NJ. Federal records list the affected scope as 431 units.
The documented reason for this recall is: A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb Nebulizer module to the Servo-i device successfully. Distribution data in the federal record shows the product reached: Domestic distribution to AZ CA GA IL MN MO NC NJ NY RI SC TX VA WI WV Foreign distributed to Bosnia and Herzegovina, Czech Republic, France, Germany, India, Indonesia, Iraq, Italy, Kenya, Republic of…. 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
431 units
Related Recalls
6
3 from same agency
Product description
Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it can be used for low end to high end intensive care, in different configurations. It supports a variety of breathing modes and can be used for Neonates, Pediatric and Adults.
Reason for recall
A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb Nebulizer module to the Servo-i device successfully.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0092-2021 |
| Date reported | October 21, 2020 |
| Date initiated | September 17, 2020 |
| Recalling firm | Getinge Group Logistics America, LLC |
| Firm location | Wayne, NJ |
| Affected scope | 431 units |
| Distribution | Domestic distribution to AZ CA GA IL MN MO NC NJ NY RI SC TX VA WI WV Foreign distributed to Bosnia and Herzegovina, Czech Republic, France, Germany, India, Indonesia, Iraq, Italy, Kenya, Republic of Korea, Lebanon, Li… |
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-0092-2021) 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? ▼
Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it can be used for low end to high end intensive care, in different configurations. It supports a variety of breathing modes and can be used for Neonates, Pediatric and Adults.. Recalled by Getinge Group Logistics America, LLC. Units affected: 431 units.
Why was this product recalled? ▼
A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb Nebulizer module to the Servo-i device successfully.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 21, 2020. Severity: Moderate. Recall number: Z-0092-2021.
Where was the recalled product distributed? ▼
Distribution: Domestic distribution to AZ CA GA IL MN MO NC NJ NY RI SC TX VA WI WV Foreign distributed to Bosnia and Herzegovina, Czech Republic, France, Germany, India, Indonesia, Iraq, Italy, Kenya, Republic of Korea, Lebanon, Libyan Arab Jamahiriya, Norway, Palestine, Peru, Qatar, Saudi Arabia,Slovakia, Sri Lanka, Sweden Thailand, Turkmenistan, Ukraine and United Arab Emirates..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0092-2021) 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 October 21, 2020. 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.