--- title: "Unomedical A/S Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Unomedical A/S recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/unomedical-a-s/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Unomedical A/S recall records **5** reported ongoing 6 records in this archive. Latest source date Jul 23, 2024. 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 23, 2024 FDA device enforcement ### [VariSoft Infusion Set, Single Use.](https://isitonrecall.com/recall/fda-device-z-3186-2024-varisoft-infusion-set-single-use/) Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set". Class II Reported ongoing Distribution: US Nationwide distribution in the state of California. [Official source for VariSoft Infusion Set, Single Use.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3186-2024%22) Mar 5, 2024 FDA device enforcement ### [Neria Soft Infusion Set, Product Code 507302, intravascular administration set](https://isitonrecall.com/recall/fda-device-z-1544-2024-neria-soft-infusion-set-product-code-507302-intravascular-administration-set/) Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) within the final pack. The IFU included is the IFU registered for the Rest of World (ROW) countries. The di... Class II Reported ongoing Distribution: US Nationwide distribution in the state of Florida. [Official source for Neria Soft Infusion Set, Product Code 507302, intravascular administration set](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1544-2024%22) Oct 11, 2023 FDA device enforcement ### [VariSoft infusion set, Model Number 1002827](https://isitonrecall.com/recall/fda-device-z-0232-2024-varisoft-infusion-set-model-number-1002827/) The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set than expected, re... Class I Reported ongoing Distribution: US Nationwide distribution in the state of CA. [Official source for VariSoft infusion set, Model Number 1002827](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0232-2024%22) Oct 11, 2023 FDA device enforcement ### [VariSoft infusion set, Model Number 1002828](https://isitonrecall.com/recall/fda-device-z-0233-2024-varisoft-infusion-set-model-number-1002828/) The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set than expected, re... Class I Reported ongoing Distribution: US Nationwide distribution in the state of CA. [Official source for VariSoft infusion set, Model Number 1002828](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0233-2024%22) Oct 11, 2023 FDA device enforcement ### [VariSoft infusion set, Model Number 1002830](https://isitonrecall.com/recall/fda-device-z-0234-2024-varisoft-infusion-set-model-number-1002830/) The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set than expected, re... Class I Reported ongoing Distribution: US Nationwide distribution in the state of CA. [Official source for VariSoft infusion set, Model Number 1002830](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0234-2024%22) Jul 21, 2022 FDA device enforcement ### [Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.](https://isitonrecall.com/recall/fda-device-z-1810-2022-autosoft-90-model-numbers-1000282-1002817-1002818-1002819-1002820-1002821-1002822-1002823-and-100282/) The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an initial insulin infusion to be fewer units than intended. Class II Reported terminated Distribution: Distribution was made to California. There was no government/military distribution. [Official source for Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1810-2022%22) ## Reasons in these listed records - Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set". - Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) within the final pack. The IFU included is the IFU registered for the Rest of World (ROW) countries. The difference between the... - The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set than expected, requiring less force t... - The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set than expected, requiring less force t... These examples come from this result page and are not a ranking of every recall reason. ## Checking Unomedical A/S ### Is there a recall on unomedical a/s right now? This archive contains 6 records, including 5 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 Unomedical A/S](https://isitonrecall.com/check/?q=Unomedical%20A%2FS) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)