FDA Classifies AirLife Broselow Pediatric Tape Recall as Class I Over Dosing Misprints

The US Food and Drug Administration has classified AirLife's removal of certain Broselow Pediatric Emergency Rainbow Tapes and Broselow ALS Organizers as a Class I recall, its most serious type, after the company found three medication-dosing errors printed on the tapes. The FDA updated its notice on February 11 to announce the classification, following an Early Alert it issued on January 16.

The Broselow tape is a color-coded, length-based tape used in pediatric emergencies. According to the FDA, a child's height corresponds to a color zone and weight range, and each zone gives pre-calculated medication doses, equipment sizes and other emergency information to cut the time needed for calculations in time-critical situations.

Three dosing errors

The recall covers all lots of Revision 3 of the tapes, reference numbers 7700REA and 7700RE, and of the full Broselow ALS Organizers, reference numbers 7730ALS and 7730IALS. The FDA said the affected version is identified with the AirLife brand, 2025 Edition, and the print version 36-23446 Rev 3.

AirLife stated that the version contains three medication-related errors, the FDA said:

• Vecuronium: in the tape's calculation basis reference section, the dose is shown as 0.1 mg/mL, a concentration, instead of the correct weight-based dose of 0.1 mg/kg. The FDA said the error can cause confusion and delays as clinicians interpret the information in an emergency.
• Flumazenil: the reference section shows 0.1 mg/kg instead of the correct 0.01 mg/kg. The color-coded sections list the correct dose, but the reference table "represents a 10-fold overdose," according to the notice.
• Ketamine: the tape lists IV/IO ketamine for pain as 1 mg/kg, while the notice gives the appropriate pediatric analgesic dose as 0.1 mg/kg, which it also describes as a 10-fold overdose.

"The clinical consequences for incorrect medication doses based on the printed information may be serious or life-threatening," the FDA said. As of November 14, AirLife had not reported any serious injuries or deaths associated with the issue, according to the notice.

Removal and earlier recall

AirLife sent customers a letter on December 15 telling them to stop using the affected tapes, identify and quarantine them, remove them from clinical service, follow its instructions for destroying them, inform clinicians, and notify any downstream customers. The FDA said it is reviewing information about the issue and will update the public as significant new information becomes available.

The FDA's recall database entry for the 7700RE tape, recall number Z-1115-2026, names SunMed Holdings, LLC, of Grand Rapids, Michigan, as the recalling firm and lists 20,583 units in commerce, with distribution across the US and to Canada, Hong Kong and Singapore.

It is the second Class I recall of Broselow tapes in less than a year. In July 2025, the FDA posted a separate notice about AirLife's removal of tapes with the print version 36-23446 Rev 2, which it said had incorrect values printed in the red, orange and grey zones, including joules for cardioversion and defibrillation and sodium bicarbonate concentration. AirLife had not reported any serious injuries or deaths in that case either, according to that notice.