--- title: "BALT USA, LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search BALT USA, 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/balt-usa-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # BALT USA, LLC recall records **8** reported ongoing 8 records in this archive. Latest source date Sep 25, 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 Sep 25, 2025 FDA device enforcement ### [Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Produ...](https://isitonrecall.com/recall/fda-device-z-0188-2026-brand-name-mega-ballast-distal-access-platform-product-name-mega-ballast-model-catalog-number-megabt/) Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen. Class I Reported ongoing Distribution: US distribution to states of: AL, CA, CO, CT, FL, IL, KY, MA, NY, TN, TX, and UT. [Official source for Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0188-2026%22) May 8, 2025 FDA device enforcement ### [Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI...](https://isitonrecall.com/recall/fda-device-z-1988-2025-optima-coil-system-refs-udi-di-codes-opti0156blk-00810068568875-opti0158blk-00810068568882-opti0103b/) Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification. Class II Reported ongoing Distribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IL, IN, KS, KY, MA, ME, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, O... [Official source for Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1988-2025%22) May 8, 2025 FDA device enforcement ### [Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445CPKPLT 00810068567724 PRES0103CXPPLT 00...](https://isitonrecall.com/recall/fda-device-z-1989-2025-prestige-coil-system-refs-udi-di-codes-pres0153cxpplt-00810068567311-pres1045cpkplt-00810068567663-p/) Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification. Class II Reported ongoing Distribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IL, IN, KS, KY, MA, ME, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, O... [Official source for Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 008100685676...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1989-2025%22) Jan 3, 2024 FDA device enforcement ### [Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intra...](https://isitonrecall.com/recall/fda-device-z-1041-2024-neurovascular-embolization-device-the-optima-coil-system-is-a-series-specialized-coils-that-are-inse/) Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the delivery pusher. D... Class II Reported ongoing Distribution: U.S.: AZ, CA, CO, FL, GA, HI, IL, KS, MA, ME, MO, MS, NC, NE, NH, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA, VT, WI and Puerto Rico O.U.S.: Argentina, Australia, Brazil, Canada, Ch... [Official source for Neurovascular embolization device. The Optima Coil System is a series specialized coils that are ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1041-2024%22) Jan 3, 2024 FDA device enforcement ### [The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to...](https://isitonrecall.com/recall/fda-device-z-1042-2024-the-prestige-coil-system-is-a-product-family-of-embolic-coils-with-associated-delivery-system-compon/) Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the delivery pusher. D... Class II Reported ongoing Distribution: U.S.: AZ, CA, CO, FL, GA, HI, IL, KS, MA, ME, MO, MS, NC, NE, NH, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA, VT, WI and Puerto Rico O.U.S.: Argentina, Australia, Brazil, Canada, Ch... [Official source for The Prestige Coil System is a product family of embolic coils with associated delivery system com...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1042-2024%22) Sep 7, 2022 FDA device enforcement ### [Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.](https://isitonrecall.com/recall/fda-device-z-0103-2023-optima-coil-system-model-number-opti0208css10-model-number-opti0308css10-used-in-endovascular-proced/) Product pouch label does not match up with carton label Class II Reported ongoing Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of FL, GA, NC, and PA. The countries of Dominican Republic, India and Japan. [Official source for Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular p...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0103-2023%22) Jul 26, 2022 FDA device enforcement ### [Optima Coil System Model OPTI0520CSF10. For endovascular embolization.](https://isitonrecall.com/recall/fda-device-z-1680-2022-optima-coil-system-model-opti0520csf10-for-endovascular-embolization/) Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier. Class II Reported ongoing Distribution: U.S.: AZ and FL O.U.S.: None [Official source for Optima Coil System Model OPTI0520CSF10. For endovascular embolization.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1680-2022%22) Jan 4, 2022 FDA device enforcement ### [The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil ...](https://isitonrecall.com/recall/fda-device-z-0660-2022-the-optima-coil-system-consists-of-an-implantable-embolization-coil-comprised-of-a-platinum-tungsten/) Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate manufacturing line clearance. As a result of this labeling mix-up, there is the possibility of inadvertently selecting the incorrect coil s... Class II Reported ongoing Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of FL and MD. The countries of Denmark, France, Germany, Lebanon, Netherlands, Sweden, Peru, Portugal, Sloven... [Official source for The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungs...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0660-2022%22) ## Reasons in these listed records - Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen. - Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification. - Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the delivery pusher. Due to the location o... - Product pouch label does not match up with carton label These examples come from this result page and are not a ranking of every recall reason. ## Checking BALT USA, LLC ### Is there a recall on balt usa, llc right now? This archive contains 8 records, including 8 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 BALT USA, LLC](https://isitonrecall.com/check/?q=BALT%20USA%2C%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)