SunMed 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.
Read the official notice →- Date
- 2026-02-04
- Country
- United States
- Brand
- SunMed Holdings
- Product
- Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applicable…
- Classification
- Class I
- Units
- Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More SunMed Holdings recalls
- 2025-07-02
USSunMed 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
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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
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FDA · DeviceSunMed Holdings, LLCUS Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL,…Official notice → - 2023-02-01
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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
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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.
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Elekta, Inc. recalls Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version:…
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Sato Pharmaceutical Co., Ltd recalls INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato…
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