--- title: "Freudenberg Medical, Llc Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Freudenberg Medical, 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/freudenberg-medical-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Freudenberg Medical, Llc recall records **2** reported ongoing 4 records in this archive. Latest source date Jun 17, 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 Jun 17, 2026 FDA device enforcement ### [Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF](https://isitonrecall.com/recall/fda-device-z-2909-2026-blom-singer-classic-indwelling-voice-prosthesis-16fr-10-mm-ref-1610-lef/) Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange. Class II Reported ongoing Distribution: US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA. [Official source for Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2909-2026%22) Jun 17, 2026 FDA device enforcement ### [Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF](https://isitonrecall.com/recall/fda-device-z-2910-2026-blom-singer-classic-indwelling-voice-prosthesis-16fr-10-mm-ref-1610-lf/) Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange. Class II Reported ongoing Distribution: US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA. [Official source for Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2910-2026%22) Feb 21, 2022 FDA device enforcement ### [Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)](https://isitonrecall.com/recall/fda-device-z-1016-2022-empower-introducer-sheath-with-hydrophilic-coating-21f-x-56cm-model-668782-100-us/) Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia Class II Reported terminated Distribution: US distribution: GA, OH Foreign distribution: Netherlands [Official source for Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1016-2022%22) Feb 21, 2022 FDA device enforcement ### [Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)](https://isitonrecall.com/recall/fda-device-z-1017-2022-empower-introducer-sheath-with-hydrophilic-coating-21f-x-56cm-model-668782-200-ous/) Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia Class II Reported terminated Distribution: US distribution: GA, OH Foreign distribution: Netherlands [Official source for Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1017-2022%22) ## Reasons in these listed records - Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange. - Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia These examples come from this result page and are not a ranking of every recall reason. ## Checking Freudenberg Medical, Llc ### Is there a recall on freudenberg medical, llc right now? This archive contains 4 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 Freudenberg Medical, Llc](https://isitonrecall.com/check/?q=Freudenberg%20Medical%2C%20Llc) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)