--- title: "Stradis Healthcare Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search 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-healthcare/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Stradis Healthcare recall records **19** reported ongoing 20 records in this archive. Latest source date Dec 15, 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 Dec 15, 2022 FDA device enforcement ### [Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile](https://isitonrecall.com/recall/fda-device-z-0931-2023-stradis-healthcare-foley-catheter-insertion-tray-with-preconnected-bag-and-catheter-sterile/) Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA. [Official source for Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0931-2023%22) Dec 15, 2022 FDA device enforcement ### [PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc.](https://isitonrecall.com/recall/fda-device-z-0932-2023-phs-lacertaion-tray-sterile-20-per-case-manufactured-for-professional-hosptial-supply-inc/) Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA. [Official source for PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0932-2023%22) Dec 15, 2022 FDA device enforcement ### [Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.](https://isitonrecall.com/recall/fda-device-z-0933-2023-henry-shein-cysto-set-up-pack-20-per-case-distributed-by-henry-schein/) Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA. [Official source for Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0933-2023%22) Dec 15, 2022 FDA device enforcement ### [Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs, 10 packs per case; b. Glove 7.0 Pack, 25 Pairs, 10 packs per case; c. Glove 7....](https://isitonrecall.com/recall/fda-device-z-0934-2023-henry-shein-gloves-packaged-in-the-following-sizes-and-descriptions-a-glove-6-5-pack-25-pairs-10-pac/) Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA. [Official source for Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0934-2023%22) Dec 15, 2022 FDA device enforcement ### [PICC KIT, 10/CS, ACCESS MEDICAL LABEL](https://isitonrecall.com/recall/fda-device-z-0935-2023-picc-kit-10-cs-access-medical-label/) Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA. [Official source for PICC KIT, 10/CS, ACCESS MEDICAL LABEL](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0935-2023%22) Dec 15, 2022 FDA device enforcement ### [HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.](https://isitonrecall.com/recall/fda-device-z-0936-2023-hct-500ml-bags-2-port-sterile-triple-packaged-10-eva-bags-pack-7-packs-per-case-distributed-by-healt/) Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA. [Official source for HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0936-2023%22) Dec 15, 2022 FDA device enforcement ### [HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.](https://isitonrecall.com/recall/fda-device-z-0937-2023-hct-50ml-eva-bags-2-port-sterile-tripple-packaged-20-eva-bags-pack-7-packs-per-case-distributed-by-h/) Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA. [Official source for HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distrib...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0937-2023%22) Dec 15, 2022 FDA device enforcement ### [HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.](https://isitonrecall.com/recall/fda-device-z-0938-2023-hct-12-cc-syringe-kit-20-tray-5-trays-bag-5-bags-case-hct-distributed-by-health-care-technology/) Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA. [Official source for HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0938-2023%22) Dec 15, 2022 FDA device enforcement ### [HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.](https://isitonrecall.com/recall/fda-device-z-0939-2023-hct-6-cc-syringe-kit-25-tray-4-trays-bag-5-bags-case-distributed-by-health-care-technology/) Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA. [Official source for HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0939-2023%22) Dec 15, 2022 FDA device enforcement ### [HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Technology](https://isitonrecall.com/recall/fda-device-z-0940-2023-hct-central-line-insertion-tray-i2-per-case-distributed-by-health-care-technology/) Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA. [Official source for HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Technology](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0940-2023%22) Dec 15, 2022 FDA device enforcement ### [HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology](https://isitonrecall.com/recall/fda-device-z-0941-2023-hct-max-barrier-picc-insertion-tray-12-per-case-distributed-by-health-care-technology/) Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA. [Official source for HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0941-2023%22) Dec 15, 2022 FDA device enforcement ### [Stradis Healthcare NEONATAL PICC Tray \*PGBK\* 20 trays per case. Manufactured by Stradis Healthcare, Distributed by Med Alliance Group](https://isitonrecall.com/recall/fda-device-z-0942-2023-stradis-healthcare-neonatal-picc-tray-pgbk-20-trays-per-case-manufactured-by-stradis-healthcare-dist/) Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA. [Official source for Stradis Healthcare NEONATAL PICC Tray \*PGBK\* 20 trays per case. Manufactured by Stradis Healthcar...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0942-2023%22) Dec 15, 2022 FDA device enforcement ### [McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution.](https://isitonrecall.com/recall/fda-device-z-0943-2023-mccormick-medical-distribution-port-tray-25-trays-per-case-distributed-by-mccormick-medical-distribu/) Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA. [Official source for McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Dis...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0943-2023%22) Dec 15, 2022 FDA device enforcement ### [Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.](https://isitonrecall.com/recall/fda-device-z-0944-2023-stradis-healthcare-tctr-convenience-kit-manufactured-by-stradis-healthcare/) Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA. [Official source for Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0944-2023%22) Dec 15, 2022 FDA device enforcement ### [Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.](https://isitonrecall.com/recall/fda-device-z-0945-2023-tacy-medical-inc-fluid-filter-transfer-kit-sterile-60-kits-per-bag-5-bags-per-case-manufactured-for/) Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA. [Official source for Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactu...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0945-2023%22) Dec 15, 2022 FDA device enforcement ### [Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.](https://isitonrecall.com/recall/fda-device-z-0946-2023-tacy-medical-inc-syringe-convenience-pack-iml-l-l-sterile-60-packs-per-bag-5-bags-per-case-manufactu/) Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA. [Official source for Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0946-2023%22) Dec 15, 2022 FDA device enforcement ### [Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.](https://isitonrecall.com/recall/fda-device-z-0947-2023-tacy-medical-inc-port-access-tray-sterile-qty-20-manufactured-for-tracy-medical-inc/) Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA. [Official source for Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0947-2023%22) Dec 15, 2022 FDA device enforcement ### [Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.](https://isitonrecall.com/recall/fda-device-z-0948-2023-vital-care-products-neonatal-picc-tray-sterile-qty-20-manufactured-for-vital-care-products-inc/) Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA. [Official source for Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0948-2023%22) May 10, 2022 FDA device enforcement ### [VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS](https://isitonrecall.com/recall/fda-device-z-1688-2022-vygon-dressing-change-w-maxiswab-kit-ref-ams-8465cs/) Potential for incomplete seals. Class II Reported ongoing Distribution: Pennsylvania [Official source for VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1688-2022%22) Apr 22, 2022 FDA device enforcement ### [Surgical Suture Kit](https://isitonrecall.com/recall/fda-device-z-1132-2022-surgical-suture-kit/) There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity. Class II Reported terminated Distribution: US Distribution to NC. [Official source for Surgical Suture Kit](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1132-2022%22) ## Reasons in these listed records - Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. - Potential for incomplete seals. - There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity. These examples come from this result page and are not a ranking of every recall reason. ## Checking Stradis Healthcare ### Is there a recall on stradis healthcare right now? This archive contains 20 records, including 19 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 Healthcare](https://isitonrecall.com/check/?q=Stradis%20Healthcare) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)