Drug & Device Safety Atlas

FDA recall record · openFDA

SunMed Holdings, LLC

15 FDA recalls on record (2023–2025) — 15 device. 15 still ongoing.

6
Class I (most serious)
9
Class II
0
Class III
15
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. 9
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. 4
The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, 1
Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exha 1

Recalls

Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Ve Class I 2025-12-15 Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36 Class I 2025-05-15 Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Ve Class I 2025-12-15 Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F Class I 2025-05-01 Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software Versio Class I 2025-12-15 Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software V Class I 2025-12-15 Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resus Class II 2023-10-11 Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include Class II 2023-10-11 Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include: Class II 2023-10-11 Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations to include: Class II 2023-10-11 Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1 Class II 2023-10-11 Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Class II 2023-10-11 Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Class II 2023-10-11 Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex A Class II 2023-10-11 Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurations to include: 1 Class II 2023-10-11

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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