Severity
Low
FDA Devices recall · Reported August 19, 2020
The UDI on the device label indicates incorrect manufacturer.
Linet Americas recalled AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontan… - a low-severity action.
AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontan… was recalled by Linet Americas in August 19, 2020. Reason: The UDI on the device label indicates incorrect manufacturer.. Check the official notice for the remedy. Verify recall #Z-2781-2020 with the FDA Devices before acting.
The recall
Linet Americas issued this low-severity FDA Devices recall-The UDI on the device label indicates incorrect manufacturer..
Sourced from official FDA Devices enforcement records. Verify recall #Z-2781-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2781-2020) was formally reported on August 19, 2020, with the manufacturer initiating the action on March 6, 2020. It is classified under Low severity (Class III), with a current status of Ongoing. Linet Americas is listed as the recalling firm, operating out of Charlotte, NC. Federal records list the affected scope as 202 devices.
The documented reason for this recall is: The UDI on the device label indicates incorrect manufacturer. Distribution data in the federal record shows the product reached: US Nationwide distribution including in the states of Arkansas, California, Delaware, Florida, Georgia, Indiana, Louisiana, Massachusetts, Minnesota, Mississippi, Missouri, New Jersey, Oklahoma, Pennsylvania, Tennessee,…. 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.
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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Low
Affected scope
202 devices
Related Recalls
6
3 from same agency
AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also as aid to search for individual positions providing relief in all delivery stages including postpartum period. Birthing bed is not intended for use as a general hospital bed.
The UDI on the device label indicates incorrect manufacturer.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Ongoing |
| Recall number | Z-2781-2020 |
| Date reported | August 19, 2020 |
| Date initiated | March 6, 2020 |
| Recalling firm | Linet Americas |
| Firm location | Charlotte, NC |
| Affected scope | 202 devices |
| Distribution | US Nationwide distribution including in the states of Arkansas, California, Delaware, Florida, Georgia, Indiana, Louisiana, Massachusetts, Minnesota, Mississippi, Missouri, New Jersey, Oklahoma, Pennsylvania, Tennessee, Texas, West Virgini… |
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.
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.
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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 August 19, 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.