CLASS I ONGOING Device recall · Reported 4 Feb 2026 · FDA Enforcement Report

Broselow Pediatric Emergency Rainbow Tape recalled by SunMed Holdings

SunMed Holdings is recalling Broselow Pediatric Emergency Rainbow Tape, distributed nationwide in the US. The recall was initiated on 15 Dec 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot Code: Lot/Serial Number(s) 0004325583 0004329077 0004329078 0004329079 0004331255 0004333368 0004335537 0004338439 0004340824 UDI-DI Each-10889483588963 Case-30889483588967

Quantity recalled20583

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-1115-2026
FDA event ID: 98208
Recalling firm: SunMed Holdings, Grand Rapids, MI
Classification: Class I
Status: Ongoing
Recall initiated: 15 Dec 2025
FDA classified: 28 Jan 2026
Reported: 4 Feb 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

15 Dec 2025	Recall initiated by company
28 Jan 2026	Classified by FDA	+44 days
4 Feb 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.

Nationwide

Questions about this recall

Why was it recalled?

Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.

Which lots are affected?

Lot Code: Lot/Serial Number(s) 0004325583 0004329077 0004329078 0004329079 0004331255 0004333368 0004335537 0004338439 0004340824 UDI-DI Each-10889483588963 Case-30889483588967

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.

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.

Other products in this recall event

3 other products · FDA event 98208

Reported	Class	Recall	Company	Reason	Where
4 Feb 2026	CLASS I	Broselow Domestic Complete ALS Organizer recalled by SunMed Holdings	SunMed Holdings	Device Malfunction	Nationwide
4 Feb 2026	CLASS I	Broselow" Filled Broselow Organizer recalled by SunMed Holdings	SunMed Holdings	Device Malfunction	Nationwide
4 Feb 2026	CLASS I	Broselow Pediatric Emergency Rainbow Tape recalled by SunMed Holdings	SunMed Holdings	Device Malfunction	Nationwide

More recalls from SunMed Holdings

All 18

Reported	Class	Recall	Company	Reason	Where
4 Feb 2026Device	CLASS I	Broselow Pediatric Emergency Rainbow Tape recalled by SunMed Holdings	SunMed Holdings	Device Malfunction	Nationwide
4 Feb 2026Device	CLASS I	Broselow" Filled Broselow Organizer recalled by SunMed Holdings	SunMed Holdings	Device Malfunction	Nationwide
4 Feb 2026Device	CLASS I	Broselow Domestic Complete ALS Organizer recalled by SunMed Holdings	SunMed Holdings	Device Malfunction	Nationwide
2 Jul 2025Device	CLASS I	Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife) recalled	SunMed Holdings	Other	Nationwide
11 Jun 2025Device	CLASS I	Adult Manual Resuscitator with Medium Adult Mask recalled	SunMed Holdings	Device Malfunction	Nationwide

Other Medical Software recalls

All 903

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Philips Brilliance recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips IQon Spectral CT recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Ingenuity CT recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Brilliance CT 64: Brilliance CT 64 Channel recalled	Philips North America	Device Malfunction	MA
8 Sep 2026Device	ANNOUNCED	BMC Luna G3 APAP recalled by BMC MedicalBMC	BMC Medical	Device Malfunction	Nationwide