Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported March 18, 2026
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4.0.2 / 10884521856134 The Vital Sync" Informatics Manager is software that is intend
Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Covidien LLC recalled HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Numb… - a moderate-severity action.
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Numb… was recalled by Covidien LLC in March 18, 2026. Reason: Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not ala…. Check the official notice for the remedy. Verify recall #Z-1557-2026 with the FDA Devices before acting.
The recall
Covidien LLC issued this moderate-severity FDA Devices recall-Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not ala….
- Moderate
- severity level
- Class II
- classification
- March 18, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1557-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1557-2026) was formally reported on March 18, 2026, with the manufacturer initiating the action on January 30, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. Covidien LLC is listed as the recalling firm, operating out of Boulder, CO. Federal records list the affected scope as 78 systems.
The documented reason for this recall is: Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system. Distribution data in the federal record shows the product reached: Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, FL, GA, IL, IN, KY, LA, MI, MN, MS, NC, NY, OH, OK, OR, SC, TN, TX, and VA. The country of Spain.. 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
78 systems
Related Recalls
6
3 from same agency
Product description
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4.0.2 / 10884521856134 The Vital Sync" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS).
Reason for recall
Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1557-2026 |
| Date reported | March 18, 2026 |
| Date initiated | January 30, 2026 |
| Recalling firm | Covidien LLC |
| Firm location | Boulder, CO |
| Affected scope | 78 systems |
| Distribution | Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, FL, GA, IL, IN, KY, LA, MI, MN, MS, NC, NY, OH, OK, OR, SC, TN, TX, and VA. The country of Spain. |
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-1557-2026) 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? ▼
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4.0.2 / 10884521856134 The Vital Sync" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS).. Recalled by Covidien LLC. Units affected: 78 systems.
Why was this product recalled? ▼
Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 18, 2026. Severity: Moderate. Recall number: Z-1557-2026.
Where was the recalled product distributed? ▼
Distribution: Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, FL, GA, IL, IN, KY, LA, MI, MN, MS, NC, NY, OH, OK, OR, SC, TN, TX, and VA. The country of Spain..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1557-2026) 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 March 18, 2026. 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.