PlainRecalls

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.

Reported: July 2, 2025 Initiated: May 15, 2025 #Z-1904-2025 9900 eaches units

SunMed Holdings, LLC issued this FDA Devices recall on July 2, 2025. Classified as Critical severity (Class I). Approximately 9900 eaches units are affected. The recall was issued because: The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

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 indicate 9900 eaches units are affected.

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.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Critical

Units Affected

9900 eaches

Related Recalls

6

6 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.

Details

Recalling Firm
SunMed Holdings, LLC
Units Affected
9900 eaches
Distribution
US distribution nationwide. International distribution to Canada.
Location
Grand Rapids, MI

Recall Profile

Structured summary of the FDA Devices recall record
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
Units affected 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.

Scale of Impact

9900 eaches units affected — limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units)
Large-scale (100K – 1M units)
Massive (≥1M units)

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

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.

Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as critical severity, meaning the product carries a reasonable probability of serious adverse health consequences or death. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

Compare this recall with Endo-Model Replacement Plateau; Item Number: 15-0027/11; →

Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
  • Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

All federal data sources used on this page

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).