--- title: "Stradis Medical, LLC dba Stradis Healthcare Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Stradis Medical, LLC dba Stradis 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/stradis-medical-llc-dba-stradis-healthcare/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Stradis Medical, LLC dba Stradis Healthcare recall records **86** reported ongoing 87 records in this archive. Latest source date Nov 2, 2022. 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 Nov 2, 2022 FDA device enforcement ### [STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431](https://isitonrecall.com/recall/fda-device-z-0481-2023-stradis-healthcare-weckcell-eye-spears-item-numbers-a-9430-b-9431/) Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US nationwide distribution, and Canada. [Official source for STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0481-2023%22) Nov 2, 2022 FDA device enforcement ### [ACE Surgical Supply, 17539 CUSTOM KIT STERILE Item No.003-3880, oral surgery tray](https://isitonrecall.com/recall/fda-device-z-0482-2023-ace-surgical-supply-17539-custom-kit-sterile-item-no-003-3880-oral-surgery-tray/) Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US nationwide distribution, and Canada. [Official source for ACE Surgical Supply, 17539 CUSTOM KIT STERILE Item No.003-3880, oral surgery tray](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0482-2023%22) Nov 2, 2022 FDA device enforcement ### [STRADIS HEALTHCARE, Perio Surgery, Item No. 20177RPSS](https://isitonrecall.com/recall/fda-device-z-0483-2023-stradis-healthcare-perio-surgery-item-no-20177rpss/) Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US nationwide distribution, and Canada. [Official source for STRADIS HEALTHCARE, Perio Surgery, Item No. 20177RPSS](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0483-2023%22) Nov 2, 2022 FDA device enforcement ### [BASIC IMPLANT PACK, Item No. 40310SBI, oral surgery tray](https://isitonrecall.com/recall/fda-device-z-0484-2023-basic-implant-pack-item-no-40310sbi-oral-surgery-tray/) Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US nationwide distribution, and Canada. [Official source for BASIC IMPLANT PACK, Item No. 40310SBI, oral surgery tray](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0484-2023%22) Nov 2, 2022 FDA device enforcement ### [STRADIS HEALTHCARE, Surg Pack, Item No.40450SMS, dental](https://isitonrecall.com/recall/fda-device-z-0485-2023-stradis-healthcare-surg-pack-item-no-40450sms-dental/) Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US nationwide distribution, and Canada. [Official source for STRADIS HEALTHCARE, Surg Pack, Item No.40450SMS, dental](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0485-2023%22) Nov 2, 2022 FDA device enforcement ### [STRADIS HEALTHCARE, Surgical Pk, Item No.40510TWS, oral surgery tray](https://isitonrecall.com/recall/fda-device-z-0486-2023-stradis-healthcare-surgical-pk-item-no-40510tws-oral-surgery-tray/) Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US nationwide distribution, and Canada. [Official source for STRADIS HEALTHCARE, Surgical Pk, Item No.40510TWS, oral surgery tray](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0486-2023%22) Nov 2, 2022 FDA device enforcement ### [STRADIS HEALTHCARE, Surg, Item No.40551TMS. oral surgery tray](https://isitonrecall.com/recall/fda-device-z-0487-2023-stradis-healthcare-surg-item-no-40551tms-oral-surgery-tray/) Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US nationwide distribution, and Canada. [Official source for STRADIS HEALTHCARE, Surg, Item No.40551TMS. oral surgery tray](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0487-2023%22) Nov 2, 2022 FDA device enforcement ### [STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray](https://isitonrecall.com/recall/fda-device-z-0488-2023-stradis-healthcare-basic-implant-pack-item-no-40561bip-oral-surgery-tray/) Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US nationwide distribution, and Canada. [Official source for STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0488-2023%22) Nov 2, 2022 FDA device enforcement ### [STRADIS HEALTHCARE, Surgical Pk, Item No.40649ECS, dental](https://isitonrecall.com/recall/fda-device-z-0489-2023-stradis-healthcare-surgical-pk-item-no-40649ecs-dental/) Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US nationwide distribution, and Canada. [Official source for STRADIS HEALTHCARE, Surgical Pk, Item No.40649ECS, dental](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0489-2023%22) Nov 2, 2022 FDA device enforcement ### [STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray](https://isitonrecall.com/recall/fda-device-z-0490-2023-stradis-healthcare-surg-pk-item-no-40714ies-oral-surgery-tray/) Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US nationwide distribution, and Canada. [Official source for STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0490-2023%22) Nov 2, 2022 FDA device enforcement ### [STRADIS HEALTHCARE, pack Item No.40788SMS, oral surgery tray](https://isitonrecall.com/recall/fda-device-z-0491-2023-stradis-healthcare-pack-item-no-40788sms-oral-surgery-tray/) Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US nationwide distribution, and Canada. [Official source for STRADIS HEALTHCARE, pack Item No.40788SMS, oral surgery tray](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0491-2023%22) Nov 2, 2022 FDA device enforcement ### [Surgical room, SURGICAL PACK, Item No.40996WLS, oral surgery tray](https://isitonrecall.com/recall/fda-device-z-0492-2023-surgical-room-surgical-pack-item-no-40996wls-oral-surgery-tray/) Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US nationwide distribution, and Canada. [Official source for Surgical room, SURGICAL PACK, Item No.40996WLS, oral surgery tray](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0492-2023%22) Nov 2, 2022 FDA device enforcement ### [STRADIS HEALTHCARE, Implants, Item No.41015NSI, dental tray](https://isitonrecall.com/recall/fda-device-z-0493-2023-stradis-healthcare-implants-item-no-41015nsi-dental-tray/) Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US nationwide distribution, and Canada. [Official source for STRADIS HEALTHCARE, Implants, Item No.41015NSI, dental tray](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0493-2023%22) Nov 2, 2022 FDA device enforcement ### [Surgical room, Implant Pack, Item No.41111UTI, oral surgery tray](https://isitonrecall.com/recall/fda-device-z-0494-2023-surgical-room-implant-pack-item-no-41111uti-oral-surgery-tray/) Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US nationwide distribution, and Canada. [Official source for Surgical room, Implant Pack, Item No.41111UTI, oral surgery tray](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0494-2023%22) Nov 2, 2022 FDA device enforcement ### [STRADIS HEALTHCARE, DENTAL CUSTOM PACK, Item No.41137TDS,](https://isitonrecall.com/recall/fda-device-z-0495-2023-stradis-healthcare-dental-custom-pack-item-no-41137tds/) Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US nationwide distribution, and Canada. [Official source for STRADIS HEALTHCARE, DENTAL CUSTOM PACK, Item No.41137TDS,](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0495-2023%22) Nov 2, 2022 FDA device enforcement ### [STRADIS HEALTHCARE, Custom Pack, Item No.41213ATCP, dental](https://isitonrecall.com/recall/fda-device-z-0496-2023-stradis-healthcare-custom-pack-item-no-41213atcp-dental/) Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US nationwide distribution, and Canada. [Official source for STRADIS HEALTHCARE, Custom Pack, Item No.41213ATCP, dental](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0496-2023%22) Nov 2, 2022 FDA device enforcement ### [Surgical room, DENTAL SURGICAL PACK, Item No.41236SDSP](https://isitonrecall.com/recall/fda-device-z-0497-2023-surgical-room-dental-surgical-pack-item-no-41236sdsp/) Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US nationwide distribution, and Canada. [Official source for Surgical room, DENTAL SURGICAL PACK, Item No.41236SDSP](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0497-2023%22) Nov 2, 2022 FDA device enforcement ### [STRADIS HEALTHCARE, COTTON APPLICATOR 3" Item No.505-010,](https://isitonrecall.com/recall/fda-device-z-0498-2023-stradis-healthcare-cotton-applicator-3-item-no-505-010/) Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US nationwide distribution, and Canada. [Official source for STRADIS HEALTHCARE, COTTON APPLICATOR 3" Item No.505-010,](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0498-2023%22) Nov 2, 2022 FDA device enforcement ### [STRADIS HEALTHCARE, SAFETY PINS, SMALL 1" Item No.515-001](https://isitonrecall.com/recall/fda-device-z-0499-2023-stradis-healthcare-safety-pins-small-1-item-no-515-001/) Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US nationwide distribution, and Canada. [Official source for STRADIS HEALTHCARE, SAFETY PINS, SMALL 1" Item No.515-001](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0499-2023%22) Nov 2, 2022 FDA device enforcement ### [STRADIS HEALTHCARE, Introducer Kit Micro, Item No.525-038, cardiovascular](https://isitonrecall.com/recall/fda-device-z-0500-2023-stradis-healthcare-introducer-kit-micro-item-no-525-038-cardiovascular/) Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US nationwide distribution, and Canada. [Official source for STRADIS HEALTHCARE, Introducer Kit Micro, Item No.525-038, cardiovascular](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0500-2023%22) ## Reasons in these listed records - Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. These examples come from this result page and are not a ranking of every recall reason. ## Checking Stradis Medical, LLC dba Stradis Healthcare ### Is there a recall on stradis medical, llc dba stradis healthcare right now? This archive contains 87 records, including 86 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 Stradis Medical, LLC dba Stradis Healthcare](https://isitonrecall.com/check/?q=Stradis%20Medical%2C%20LLC%20dba%20Stradis%20Healthcare) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)