SunMed Holdings recalls
6 official recalls and safety alerts involving SunMed Holdings since 2022-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with SunMed Holdings or the relevant agency.
- 2026-02-04
USSunMed Holdings, LLC recalls Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applicable…
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
FDA · DeviceSunMed Holdings, LLCWorldwide distribution - US Nationwide and the countries of Canada, Hong Kong,…Official notice →- 2025-07-02
- US
SunMed Holdings, LLC recalls Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print…
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…
FDA · DeviceSunMed Holdings, LLCUS distribution nationwide. International distribution to Canada.Official notice → - 2025-06-11
- US
SunMed Holdings, LLC recalls Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
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…
- 2023-11-29
- US
SunMed Holdings, LLC recalls Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resuscitator REF #s:…
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
FDA · DeviceSunMed Holdings, LLCUS Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL,…Official notice → - 2023-02-01
- US
SunMed Holdings, LLC recalls Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 50105 1.5 50155 2.0 50205 3.0 50305…
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…
FDA · DeviceSunMed Holdings, LLCUS Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA.Official notice → - 2022-10-05
- US
SunMed Holdings, LLC recalls Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
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.
FDA · DeviceSunMed Holdings, LLCDomestic distribution to AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX.Official notice →