CLASS I ONGOING Device recall · Reported 2 Jul 2025 · FDA Enforcement Report
Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife) recalled
SunMed Holdings is recalling Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife), distributed nationwide in the US. The recall was initiated on 15 May 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1904-2025
- FDA event ID
- 96891
- Recalling firm
- SunMed Holdings, Grand Rapids, MI
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 15 May 2025
- FDA classified
- 20 Jun 2025
- Reported
- 2 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 15 May 2025 | Recall initiated by company | |
| 20 Jun 2025 | Classified by FDA | +36 days |
| 2 Jul 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US distribution nationwide. International distribution to Canada.
Questions about this recall
Why was it 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 lots are affected?
UDI-DI EA: 10889483588970 CS: 30889483588974 Lot 0004316661
Where was it sold?
US distribution nationwide. International distribution to Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from SunMed Holdings
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|---|---|---|---|---|---|
| Device | CLASS I | Broselow Pediatric Emergency Rainbow Tape recalled by SunMed Holdings | SunMed Holdings | Device Malfunction | Nationwide |
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| Device | CLASS I | Broselow Pediatric Emergency Rainbow Tape recalled by SunMed Holdings | SunMed Holdings | Device Malfunction | Nationwide |
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