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SunMed Holdings Recalls
18 recalls on record · October 5, 2022 to February 4, 2026 · Medical Devices
Recalls by year
22
23
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 4, 2026Medical DevicesFDA
SunMed Holdings, LLC recalls Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software Versio
Hazard: Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
February 4, 2026Medical DevicesFDA
SunMed Holdings, LLC recalls Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Ve
Hazard: Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
February 4, 2026Medical DevicesFDA
SunMed Holdings, LLC recalls Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Ve
Hazard: Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
February 4, 2026Medical DevicesFDA
SunMed Holdings, LLC recalls Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software V
Hazard: Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
July 2, 2025Medical DevicesFDA
SunMed Holdings, LLC recalls Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36
Hazard: The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a patient with an excessive dose of joules, causing significant harm including burns, heart damage, and cardiac arrest. Incorrect values in the Orange zone could lead to overdosing the patient with sodium bicarbonate and cause metabolic alkalosis, electrolyte imbalances, tissue damage, and worsen respiratory status. Incorrect information in the Grey may lead to underdosing the patient with sodium bicarbonate and may cause reduced myocardial contractility, decreased response to vasopressors, and increased risk of dysrhythmia.
June 11, 2025Medical DevicesFDA
SunMed Holdings, LLC recalls Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
Hazard: Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequences, including hypoxia, hypercapnia, organ failure, and death.
November 29, 2023Medical DevicesFDA
SunMed Holdings, LLC recalls Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resus
Hazard: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
November 29, 2023Medical DevicesFDA
SunMed Holdings, LLC recalls Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex A
Hazard: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
November 29, 2023Medical DevicesFDA
SunMed Holdings, LLC recalls Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1.
Hazard: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
November 29, 2023Medical DevicesFDA
SunMed Holdings, LLC recalls Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations to include:
Hazard: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
November 29, 2023Medical DevicesFDA
SunMed Holdings, LLC recalls Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1
Hazard: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
November 29, 2023Medical DevicesFDA
SunMed Holdings, LLC recalls Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurations to include: 1
Hazard: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
November 29, 2023Medical DevicesFDA
SunMed Holdings, LLC recalls Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configurations to include: 1.
Hazard: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
November 29, 2023Medical DevicesFDA
SunMed Holdings, LLC recalls Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include:
Hazard: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
November 29, 2023Medical DevicesFDA
SunMed Holdings, LLC recalls Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include
Hazard: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
February 1, 2023Medical DevicesFDA
SunMed Holdings, LLC recalls AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5
Hazard: There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastric catheter through one of the channels, the clinician may use a smaller-diameter gastric catheter.
February 1, 2023Medical DevicesFDA
SunMed Holdings, LLC recalls Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5
Hazard: There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastric catheter through one of the channels, the clinician may use a smaller-diameter gastric catheter.
October 5, 2022Medical DevicesFDA
SunMed Holdings, LLC recalls Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
Hazard: The kits are being recalled due to a lack of sterility of a spare needle contained within the kits. There is a potential for skin infection or sepsis if the patient is exposed to a non-sterilized, unused needle.