SunMed Holdings, LLC
Complete recall history across all FDA and CPSC categories — 18 total recalls
SunMed Holdings, LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (18)
FDA medical device enforcement actions by SunMed Holdings, LLC
| Date | Product | Reason | Class |
|---|---|---|---|
| Dec 15, 2025 | Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape... | Product contains potentially harmful dosing errors for Vecuronium, Flumazenil... | Class I |
| Dec 15, 2025 | Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Mode... | Product contains potentially harmful dosing errors for Vecuronium, Flumazenil... | Class I |
| Dec 15, 2025 | Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer ... | Product contains potentially harmful dosing errors for Vecuronium, Flumazenil... | Class I |
| Dec 15, 2025 | Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape... | Product contains potentially harmful dosing errors for Vecuronium, Flumazenil... | Class I |
| May 15, 2025 | Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700... | The impacted tape was manufactured with incorrect information on the tape. In... | Class I |
| May 1, 2025 | Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Mano... | Affected lots were manufactured with B/V Filter incorrectly attached to the w... | Class I |
| Oct 11, 2023 | Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multipl... | A backwards leak present in the integrated manometer of the patient valve all... | Class II |
| Oct 11, 2023 | Curaplex manual resuscitators with integrated manometer, multiple accessory c... | A backwards leak present in the integrated manometer of the patient valve all... | Class II |
| Oct 11, 2023 | Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple... | A backwards leak present in the integrated manometer of the patient valve all... | Class II |
| Oct 11, 2023 | Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple ... | A backwards leak present in the integrated manometer of the patient valve all... | Class II |
| Oct 11, 2023 | Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multipl... | A backwards leak present in the integrated manometer of the patient valve all... | Class II |
| Oct 11, 2023 | Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, mult... | A backwards leak present in the integrated manometer of the patient valve all... | Class II |
| Oct 11, 2023 | Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multi... | A backwards leak present in the integrated manometer of the patient valve all... | Class II |
| Oct 11, 2023 | Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, m... | A backwards leak present in the integrated manometer of the patient valve all... | Class II |
| Oct 11, 2023 | Medline manual resuscitators with integrated manometer, multiple accessory co... | A backwards leak present in the integrated manometer of the patient valve all... | Class II |
| Dec 22, 2022 | AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size ... | There is an orogastric (OG) tube size discrepancy between the labeling in the... | Class II |
| Dec 22, 2022 | Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size RE... | There is an orogastric (OG) tube size discrepancy between the labeling in the... | Class II |
| Sep 8, 2022 | 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 cont... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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