Medical DeviceFeb 4, 2026
Broselow Pediatric Emergency Rainbow Tape recall — FDA Z-1115-2026
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Class IFDA: OngoingSunMed Holdings, LLC
Recall history in this database
Classification mix: Class II: 12, Class I: 6.
Medical DeviceFeb 4, 2026
Broselow Domestic Complete ALS Organizer recall — FDA Z-1116-2026
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Class IFDA: OngoingSunMed Holdings, LLC
Medical DeviceFeb 4, 2026
Broselow recall — FDA Z-1117-2026
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Class IFDA: OngoingSunMed Holdings, LLC
Medical DeviceFeb 4, 2026
Broselow Pediatric Emergency Rainbow Tape recall — FDA Z-1114-2026
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Class IFDA: OngoingSunMed Holdings, LLC
Medical DeviceJul 2, 2025
SunMed Holdings Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife) recall — FDA Z-1904-2025
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…
Class IFDA: OngoingSunMed Holdings, LLC
Medical DeviceJun 11, 2025
SunMed Holdings Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter recall — FDA Z-1814-2025
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…
Class IFDA: OngoingSunMed Holdings, LLC
Medical DeviceNov 29, 2023
SunMed Holdings Medline manual resuscitators with integrated manometer, multiple accessory recall — FDA Z-0369-2024
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Class IIFDA: OngoingSunMed Holdings, LLC
Medical DeviceNov 29, 2023
SunMed Holdings Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer recall — FDA Z-0361-2024
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Class IIFDA: OngoingSunMed Holdings, LLC
Medical DeviceNov 29, 2023
SunMed Holdings Ventlab, LLC BreathTech manual resuscitators with integrated manometer recall — FDA Z-0362-2024
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Class IIFDA: OngoingSunMed Holdings, LLC
Medical DeviceNov 29, 2023
SunMed Holdings Ventlab, LLC STAT-Check manual resuscitators with integrated manometer recall — FDA Z-0366-2024
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Class IIFDA: OngoingSunMed Holdings, LLC
Medical DeviceNov 29, 2023
SunMed Holdings Ventlab, LLC SafeSpot manual resuscitators with integrated manometer recall — FDA Z-0365-2024
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Class IIFDA: OngoingSunMed Holdings, LLC
Medical DeviceNov 29, 2023
SunMed Holdings Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple recall — FDA Z-0367-2024
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Class IIFDA: OngoingSunMed Holdings, LLC
Medical DeviceNov 29, 2023
SunMed Holdings Ventlab, LLC Horizon manual resuscitators with integrated manometer recall — FDA Z-0363-2024
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Class IIFDA: OngoingSunMed Holdings, LLC
Medical DeviceNov 29, 2023
SunMed Holdings Curaplex manual resuscitators with integrated manometer, multiple accessory recall — FDA Z-0368-2024
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Class IIFDA: OngoingSunMed Holdings, LLC
Medical DeviceNov 29, 2023
SunMed Holdings Ventlab, LLC RescuMed manual resuscitators with integrated manometer recall — FDA Z-0364-2024
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Class IIFDA: OngoingSunMed Holdings, LLC
Medical DeviceFeb 1, 2023
SunMed Holdings Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number recall — FDA Z-1019-2023
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…
Class IIFDA: OngoingSunMed Holdings, LLC
Medical DeviceFeb 1, 2023
SunMed Holdings AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF recall — FDA Z-1020-2023
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…
Class IIFDA: OngoingSunMed Holdings, LLC
Medical DeviceOct 5, 2022
SunMed Holdings Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91 recall — FDA Z-1779-2022
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…
Class IIFDA: TerminatedSunMed Holdings, LLC
Understanding this recall history
This page summarizes recall records in which the official source identifies SunMed Holdings, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.