Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported July 2, 2025
Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.
The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
SunMed Holdings, LLC recalled Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirL… - a critical-severity action.
Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirL… was recalled by SunMed Holdings, LLC in July 2, 2025. Reason: The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in th…. Check the official notice for the remedy. Verify recall #Z-1904-2025 with the FDA Devices before acting.
The recall
SunMed Holdings, LLC issued this critical-severity FDA Devices recall-The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in th….
- Critical
- severity level
- Class I
- classification
- July 2, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1904-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1904-2025) was formally reported on July 2, 2025, with the manufacturer initiating the action on May 15, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. SunMed Holdings, LLC is listed as the recalling firm, operating out of Grand Rapids, MI. Federal records list the affected scope as 9900 eaches.
The documented reason for this recall is: The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a pa… Distribution data in the federal record shows the product reached: US distribution nationwide. International distribution to Canada.. 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 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
9900 eaches
Related Recalls
6
3 from same agency
Product description
Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.
Reason for recall
The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a patient with an excessive dose of joules, causing significant harm including burns, heart damage, and cardiac arrest. Incorrect values in the Orange zone could lead to overdosing the patient with sodium bicarbonate and cause metabolic alkalosis, electrolyte imbalances, tissue damage, and worsen respiratory status. Incorrect information in the Grey may lead to underdosing the patient with sodium bicarbonate and may cause reduced myocardial contractility, decreased response to vasopressors, and increased risk of dysrhythmia.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1904-2025 |
| Date reported | July 2, 2025 |
| Date initiated | May 15, 2025 |
| Recalling firm | SunMed Holdings, LLC |
| Firm location | Grand Rapids, MI |
| Affected scope | 9900 eaches |
| Distribution | US distribution nationwide. International distribution to Canada. |
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-1904-2025) 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? ▼
Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.. Recalled by SunMed Holdings, LLC. Units affected: 9900 eaches.
Why was this product recalled? ▼
The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a patient with an excessive dose of joules, causing significant harm including burns, heart damage, and cardiac arrest. Incorrect values in the Orange zone could lead to overdosing the patient with sodium bicarbonate and cause metabolic alkalosis, electrolyte imbalances, tissue damage, and worsen respiratory status. Incorrect information in the Grey may lead to underdosing the patient with sodium bicarbonate and may cause reduced myocardial contractility, decreased response to vasopressors, and increased risk of dysrhythmia.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 2, 2025. Severity: Critical. Recall number: Z-1904-2025.
Where was the recalled product distributed? ▼
Distribution: US distribution nationwide. International distribution to Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1904-2025) 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 July 2, 2025. 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.