--- title: "Spectra Medical Devices, Llc Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Spectra Medical Devices, 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/spectra-medical-devices-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Spectra Medical Devices, Llc recall records **2** reported ongoing 2 records in this archive. Latest source date Jul 6, 2026. 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 Jul 6, 2026 FDA device enforcement ### [Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing...](https://isitonrecall.com/recall/fda-device-z-2873-2026-brand-name-elevaris-spectra-medical-devices-product-name-sodium-chloride-injection-0-9-usp-10ml-ampu/) Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, in... Class I Reported ongoing Distribution: Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA. [Official source for Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 1...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2873-2026%22) May 12, 2026 FDA drug enforcement ### [Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.](https://isitonrecall.com/recall/fda-drug-d-0554-2026-lidocaine-hcl-injection-usp-25x5-ml-single-dose-ampules-rx-only-distributed-by-spectra-medical-devic/) Lack of Assurance of Sterility Class II Reported ongoing Distribution: USA Nationwide [Official source for Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medic...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0554-2026%22) ## Reasons in these listed records - Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clot... - Lack of Assurance of Sterility These examples come from this result page and are not a ranking of every recall reason. ## Checking Spectra Medical Devices, Llc ### Is there a recall on spectra medical devices, llc right now? This archive contains 2 records, including 2 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 Spectra Medical Devices, Llc](https://isitonrecall.com/check/?q=Spectra%20Medical%20Devices%2C%20Llc) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)