Exact FDA event identifier

Event 98208

4 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: December 15, 2025
Product types: Device
Classifications: Class I
Statuses: Ongoing
Recalling firm wording: SunMed Holdings, LLC

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA 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

Z-1114-2026

Recall number: Z-1114-2026
Initiated: December 15, 2025
Classification: Class I
Status: Ongoing
Recalling firm: SunMed Holdings, LLC
Quantity: 95300

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Code: Lot/Serial Number(s) 0004306540 0004316209 0004328895 0004329080 0004330876 0004331254 0004332994 0004338228 0004338229 0004338230 0004339717 UDI-DI Each-10889483588970 Case-30889483588974

Distribution pattern

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

device · product 2 of 4

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

Z-1115-2026

Recall number: Z-1115-2026
Initiated: December 15, 2025
Classification: Class I
Status: Ongoing
Recalling firm: SunMed Holdings, LLC
Quantity: 20583

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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

device · product 3 of 4

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

Z-1116-2026

Recall number: Z-1116-2026
Initiated: December 15, 2025
Classification: Class I
Status: Ongoing
Recalling firm: SunMed Holdings, LLC
Quantity: 384

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Code: Lot/Serial Number(s) 0004312284 0004314503 0004333110 UDI-DI Each-10889483589151

Distribution pattern

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

device · product 4 of 4

Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS 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

Z-1117-2026

Recall number: Z-1117-2026
Initiated: December 15, 2025
Classification: Class I
Status: Ongoing
Recalling firm: SunMed Holdings, LLC
Quantity: 89

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Code: Lot/Serial Number(s) 0004317699 0004333171 0004333593 UDI-DI Each-10889483589205 Case-30889483589209

Distribution pattern

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