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SunMed Holdings, LLC FDA Recalls
18 recalls on file across devices, 6 of them Class I and 17 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software VersioClass IDec 15, 2025Product contains potentially harmful dosing errors for Vecur |
| Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software VeClass IDec 15, 2025Product contains potentially harmful dosing errors for Vecur |
| Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software VeClass IDec 15, 2025Product contains potentially harmful dosing errors for Vecur |
| Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software VClass IDec 15, 2025Product contains potentially harmful dosing errors for Vecur |
| Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36Class IMay 15, 2025The impacted tape was manufactured with incorrect informatio |
| Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116FClass IMay 1, 2025Affected lots were manufactured with B/V Filter incorrectly |
| Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations to include: Class IIOct 11, 2023A backwards leak present in the integrated manometer of the |
| Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to includeClass IIOct 11, 2023A backwards leak present in the integrated manometer of the |
| Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1Class IIOct 11, 2023A backwards leak present in the integrated manometer of the |
| Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Class IIOct 11, 2023A backwards leak present in the integrated manometer of the |
| Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex AClass IIOct 11, 2023A backwards leak present in the integrated manometer of the |
| Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include: Class IIOct 11, 2023A backwards leak present in the integrated manometer of the |
| Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult ResusClass IIOct 11, 2023A backwards leak present in the integrated manometer of the |
| Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configurations to include: 1.Class IIOct 11, 2023A backwards leak present in the integrated manometer of the |
| Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurations to include: 1Class IIOct 11, 2023A backwards leak present in the integrated manometer of the |
| AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5 Class IIDec 22, 2022There is an orogastric (OG) tube size discrepancy between th |
| Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 Class IIDec 22, 2022There is an orogastric (OG) tube size discrepancy between th |
| Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91Class IISep 8, 2022The kits are being recalled due to a lack of sterility of a |