--- title: "Diversatek Healthcare Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Diversatek Healthcare recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/diversatek-healthcare/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Diversatek Healthcare recall records **6** reported ongoing 7 records in this archive. Latest source date Mar 18, 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 Mar 18, 2026 FDA device enforcement ### [Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08](https://isitonrecall.com/recall/fda-device-z-1938-2026-diversatek-healthcare-viper-3-stage-fixed-wire-balloon-dilator-6mm-7mm-8mm-ref-1204-08/) The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage. Class II Reported ongoing Distribution: US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium [Official source for Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1938-2026%22) Mar 18, 2026 FDA device enforcement ### [Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15](https://isitonrecall.com/recall/fda-device-z-1939-2026-diversatek-healthcare-viper-3-stage-wire-guided-balloon-dilator-12mm-13-5mm-15mm-ref-1205-15/) The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage. Class II Reported ongoing Distribution: US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium [Official source for Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1939-2026%22) Mar 18, 2026 FDA device enforcement ### [Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18](https://isitonrecall.com/recall/fda-device-z-1940-2026-diversatek-healthcare-viper-3-stage-wire-guided-balloon-dilator-15mm-16-5mm-18mm-ref-1205-18/) The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage. Class II Reported ongoing Distribution: US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium [Official source for Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1940-2026%22) Mar 18, 2026 FDA device enforcement ### [Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20](https://isitonrecall.com/recall/fda-device-z-1941-2026-diversatek-healthcare-viper-3-stage-wire-guided-balloon-dilator-18mm-19mm-20mm-ref-1205-20/) The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage. Class II Reported ongoing Distribution: US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium [Official source for Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1941-2026%22) Jun 4, 2025 FDA device enforcement ### [Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10](https://isitonrecall.com/recall/fda-device-z-2324-2025-zvu-anorectal-manometry-procedure-kit-ref-hram-proc-10/) Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit components display the correct expiration date. Class III Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea. [Official source for Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2324-2025%22) Jul 25, 2023 FDA device enforcement ### [ZVU Functional GI Software, REF: ZVU-3](https://isitonrecall.com/recall/fda-device-z-2521-2023-zvu-functional-gi-software-ref-zvu-3/) GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0. Class III Reported ongoing Distribution: worldwide - US Nationwide distribution in the states of NJ, MN, TN, WA, KY, OR, FL, GA, NY, TX, CO, KS and the countries of Japan, Saudi Arabia. [Official source for ZVU Functional GI Software, REF: ZVU-3](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2521-2023%22) Oct 29, 2021 FDA device enforcement ### [Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve severed polyps, tissue samples, food bolus, and foreign bodi...](https://isitonrecall.com/recall/fda-device-z-1771-2022-diversatek-health-m-catch-retrieval-nets-part-number-ref-1175-01-quantity-5-ea-u-used-to-endoscopica/) M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2021 and 10-22-2021, may contain incorrect inner polybag labeling. The outer package labeling is correct. Class II Reported terminated Distribution: US Nationwide distribution. [Official source for Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endo...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1771-2022%22) ## Reasons in these listed records - The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage. - Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit components display the correct expiration date. - GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0. - M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2021 and 10-22-2021, may contain incorrect inner polybag labeling. The outer package labeling is correct. These examples come from this result page and are not a ranking of every recall reason. ## Checking Diversatek Healthcare ### Is there a recall on diversatek healthcare right now? This archive contains 7 records, including 6 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 Diversatek Healthcare](https://isitonrecall.com/check/?q=Diversatek%20Healthcare) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)