--- title: "SunMed Holdings, LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search SunMed Holdings, LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/sunmed-holdings-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # SunMed Holdings, LLC recall records **17** reported ongoing 18 records in this archive. Latest source date Dec 15, 2025. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Dec 15, 2025 FDA device enforcement ### [Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Version: Not Applicable Product Description: The Broselow Tap...](https://isitonrecall.com/recall/fda-device-z-1114-2026-brand-name-broselow-product-name-broselow-pediatric-emergency-rainbow-tape-model-catalog-number-7700/) Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Class I Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore. [Official source for Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1114-2026%22) Dec 15, 2025 FDA device enforcement ### [Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applicable Product Description: The Broselow Tape...](https://isitonrecall.com/recall/fda-device-z-1115-2026-brand-name-broselow-product-name-broselow-pediatric-emergency-rainbow-tape-model-catalog-number-7700/) Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Class I Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore. [Official source for Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1115-2026%22) Dec 15, 2025 FDA device enforcement ### [Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Version: Not Applicable Product Description: The Broselow Tape...](https://isitonrecall.com/recall/fda-device-z-1116-2026-brand-name-broselow-product-name-broselow-domestic-complete-als-organizer-model-catalog-number-7730a/) Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Class I Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore. [Official source for Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number:...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1116-2026%22) Dec 15, 2025 FDA device enforcement ### [Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software Version: Not Applicable Product Description: The Broselow Tape is ...](https://isitonrecall.com/recall/fda-device-z-1117-2026-brand-name-broselow-product-name-broselow-filled-broselow-organizer-model-catalog-number-7730ials-so/) Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Class I Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore. [Official source for Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1117-2026%22) May 15, 2025 FDA device enforcement ### [Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version The Broselow Tape is a length- and...](https://isitonrecall.com/recall/fda-device-z-1904-2025-broselow-pediatric-emergency-rainbow-tape-distribution-by-airlife-ref-7700rea-airlife-brand-2025-edi/) 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 patient with an excessive dose of joules... Class I Reported ongoing Distribution: US distribution nationwide. International distribution to Canada. [Official source for Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1904-2025%22) May 1, 2025 FDA device enforcement ### [Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F](https://isitonrecall.com/recall/fda-device-z-1814-2025-adult-manual-resuscitator-with-medium-adult-mask-bag-reservoir-filter-manometer-and-7-ft-oxygen-tubi/) 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 resuscitation, which may lead to life ... Class I Reported ongoing Distribution: US Nationwide distribution via Medline. [Official source for Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxyge...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1814-2025%22) Oct 11, 2023 FDA device enforcement ### [Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include: 1. AirFlow Adult Resuscitator REF #s: AF1140MB-M5, AF11...](https://isitonrecall.com/recall/fda-device-z-0361-2024-ventlab-llc-airflow-manual-resuscitator-devices-with-integrated-manometer-multiple-accessory-configu/) A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. Class II Reported ongoing Distribution: US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV. [Official source for Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory co...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0361-2024%22) Oct 11, 2023 FDA device enforcement ### [Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. BreathTech Adult Resuscitator REF #s: BT5107F & BT5104P;...](https://isitonrecall.com/recall/fda-device-z-0362-2024-ventlab-llc-breathtech-manual-resuscitators-with-integrated-manometer-multiple-accessory-configurati/) A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. Class II Reported ongoing Distribution: US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV. [Official source for Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory config...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0362-2024%22) Oct 11, 2023 FDA device enforcement ### [Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Horizon Adult Resuscitator REF #s: 9122HZ, HZI9000, HZI9108...](https://isitonrecall.com/recall/fda-device-z-0363-2024-ventlab-llc-horizon-manual-resuscitators-with-integrated-manometer-multiple-accessory-configurations/) A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. Class II Reported ongoing Distribution: US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV. [Official source for Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configura...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0363-2024%22) Oct 11, 2023 FDA device enforcement ### [Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. RescuMed Adult Resuscitator REF #s: BVM510-F, BVMB510-10, ...](https://isitonrecall.com/recall/fda-device-z-0364-2024-ventlab-llc-rescumed-manual-resuscitators-with-integrated-manometer-multiple-accessory-configuration/) A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. Class II Reported ongoing Distribution: US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV. [Official source for Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configur...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0364-2024%22) Oct 11, 2023 FDA device enforcement ### [Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. SafeSpot Infant Resuscitator REF #s: SS3200OBPC-T, SS3204M...](https://isitonrecall.com/recall/fda-device-z-0365-2024-ventlab-llc-safespot-manual-resuscitators-with-integrated-manometer-multiple-accessory-configuration/) A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. Class II Reported ongoing Distribution: US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV. [Official source for Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configur...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0365-2024%22) Oct 11, 2023 FDA device enforcement ### [Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. STAT-Check Adult Resuscitator REF #: SC9101B; 2. STAT-Ch...](https://isitonrecall.com/recall/fda-device-z-0366-2024-ventlab-llc-stat-check-manual-resuscitators-with-integrated-manometer-multiple-accessory-configurati/) A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. Class II Reported ongoing Distribution: US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV. [Official source for Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory config...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0366-2024%22) Oct 11, 2023 FDA device enforcement ### [Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. V-Care Child Resuscitator REF #s: VN4100MB, VN4100MCFB-3, VN...](https://isitonrecall.com/recall/fda-device-z-0367-2024-ventlab-llc-v-care-manual-resuscitators-with-integrated-manometer-multiple-accessory-configurations/) A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. Class II Reported ongoing Distribution: US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV. [Official source for Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurat...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0367-2024%22) Oct 11, 2023 FDA device enforcement ### [Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex Adult Premium BVM with Bag Reservoir, Manometer, Filter, Peep ...](https://isitonrecall.com/recall/fda-device-z-0368-2024-curaplex-manual-resuscitators-with-integrated-manometer-multiple-accessory-configurations-to-include/) A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. Class II Reported ongoing Distribution: US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV. [Official source for Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to inc...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0368-2024%22) Oct 11, 2023 FDA device enforcement ### [Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resuscitator REF #s: CPRM1116FPM, CPRM1116FPM4, CPRM1116M, CPRM111...](https://isitonrecall.com/recall/fda-device-z-0369-2024-medline-manual-resuscitators-with-integrated-manometer-multiple-accessory-configurations-to-include/) A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. Class II Reported ongoing Distribution: US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV. [Official source for Medline manual resuscitators with integrated manometer, multiple accessory configurations to incl...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0369-2024%22) Dec 22, 2022 FDA device enforcement ### [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 4.0 50405](https://isitonrecall.com/recall/fda-device-z-1019-2023-air-q3-airq3-standard-ila-with-manual-cuff-inflation-and-ga-size-ref-number-0-0-50005-0-5-50055-1-0/) 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 use a smaller-diameter gastric catheter. Class II Reported ongoing Distribution: US Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA. [Official source for Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1019-2023%22) Dec 22, 2022 FDA device enforcement ### [AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5 60055 1.0 60105 1.5 60155 2.0 60205 3.0 60305 4.0 60405](https://isitonrecall.com/recall/fda-device-z-1020-2023-airq3-self-pressurizing-ila-with-automatic-cuff-inflation-and-ga-size-ref-number-0-0-60005-0-5-60055/) 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 use a smaller-diameter gastric catheter. Class II Reported ongoing Distribution: US Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA. [Official source for AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5 60...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1020-2023%22) Sep 8, 2022 FDA device enforcement ### [Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91](https://isitonrecall.com/recall/fda-device-z-1779-2022-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 contained within the kits. There is a potential for skin infection or sepsis if the patient is exposed to a non-sterilized, unused needle. Class II Reported terminated Distribution: Domestic distribution to AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX. [Official source for Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1779-2022%22) ## Reasons in these listed records - Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. - 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 patient with an excessive dose of joules, causing significan... - 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 resuscitation, which may lead to life threatening conseque... - A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. These examples come from this result page and are not a ranking of every recall reason. ## Checking SunMed Holdings, LLC ### Is there a recall on sunmed holdings, llc right now? This archive contains 18 records, including 17 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search SunMed Holdings, LLC](https://isitonrecall.com/check/?q=SunMed%20Holdings%2C%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)