Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 28, 2021
AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
Devices do not meet IEC 60601-2-27 requirements as labeled.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Welch Allyn Inc Mortara recalled AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.… - a moderate-severity action.
AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.… was recalled by Welch Allyn Inc Mortara in April 28, 2021. Reason: Devices do not meet IEC 60601-2-27 requirements as labeled.. Check the official notice for the remedy. Verify recall #Z-1485-2021 with the FDA Devices before acting.
The recall
Welch Allyn Inc Mortara issued this moderate-severity FDA Devices recall-Devices do not meet IEC 60601-2-27 requirements as labeled..
- Moderate
- severity level
- 746 units
- affected scope
- Class II
- classification
- April 28, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1485-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1485-2021) was formally reported on April 28, 2021, with the manufacturer initiating the action on March 31, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Welch Allyn Inc Mortara is listed as the recalling firm, operating out of Milwaukee, WI. Federal records list the affected scope as 746 units.
The documented reason for this recall is: Devices do not meet IEC 60601-2-27 requirements as labeled. Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of CA, CO, FL, GA, IN, LA, NC, NJ, NV, NY, OH, OK, TX, UT, and VA.. 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
746 units
Related Recalls
6
3 from same agency
Product description
AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
Reason for recall
Devices do not meet IEC 60601-2-27 requirements as labeled.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1485-2021 |
| Date reported | April 28, 2021 |
| Date initiated | March 31, 2021 |
| Recalling firm | Welch Allyn Inc Mortara |
| Firm location | Milwaukee, WI |
| Affected scope | 746 units |
| Distribution | US Nationwide distribution in the states of CA, CO, FL, GA, IN, LA, NC, NJ, NV, NY, OH, OK, TX, UT, and VA. |
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-1485-2021) 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? ▼
AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.. Recalled by Welch Allyn Inc Mortara. Units affected: 746 units.
Why was this product recalled? ▼
Devices do not meet IEC 60601-2-27 requirements as labeled.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 28, 2021. Severity: Moderate. Recall number: Z-1485-2021.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of CA, CO, FL, GA, IN, LA, NC, NJ, NV, NY, OH, OK, TX, UT, and VA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1485-2021) 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 April 28, 2021. 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.