CLASS I ONGOING Device recall · Reported 4 Feb 2026 · FDA Enforcement Report
Broselow Domestic Complete ALS Organizer recalled by SunMed Holdings
SunMed Holdings is recalling Broselow Domestic Complete ALS Organizer, 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
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-1116-2026
- 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 Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS 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.
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) 0004312284 0004314503 0004333110 UDI-DI Each-10889483589151
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 98208This product is part of a recall event; the main page for the event is Broselow Pediatric Emergency Rainbow Tape recalled by SunMed Holdings.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Broselow Pediatric Emergency Rainbow Tape recalled by SunMed Holdings | SunMed Holdings | Device Malfunction | Nationwide | |
| CLASS I | Broselow" Filled Broselow Organizer recalled by SunMed Holdings | SunMed Holdings | Device Malfunction | Nationwide | |
| 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 |
|---|---|---|---|---|---|
| Device | CLASS I | Broselow Pediatric Emergency Rainbow Tape recalled by SunMed Holdings | SunMed Holdings | Device Malfunction | Nationwide |
| Device | CLASS I | Broselow" Filled Broselow Organizer recalled by SunMed Holdings | SunMed Holdings | Device Malfunction | Nationwide |
| Device | CLASS I | Broselow Pediatric Emergency Rainbow Tape recalled by SunMed Holdings | SunMed Holdings | Device Malfunction | Nationwide |
| Device | CLASS I | Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife) recalled | SunMed Holdings | Other | Nationwide |
| Device | CLASS I | Adult Manual Resuscitator with Medium Adult Mask recalled | SunMed Holdings | Device Malfunction | Nationwide |
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| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Upgrade to MR recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Tandem t:slim mobile application t:slim Mobile Application, iOS recalled | Tandem Diabetes Care | Device Malfunction | Nationwide |
| Device | CLASS II | Ingenia Elition S and Ingenia Elition recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |