--- title: "DeRoyal Industries Inc Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search DeRoyal Industries Inc recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/deroyal-industries-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # DeRoyal Industries Inc recall records **174** reported ongoing 181 records in this archive. Latest source date May 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 May 18, 2026 FDA device enforcement ### [DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)](https://isitonrecall.com/recall/fda-device-z-2305-2026-deroyal-industries-inc-ref-46-406-covaderm-plus-vascular-access-dressing-6-x6-15cmx15cm/) Sterile wound dressing, lacks sterility assurance Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL & NC. [Official source for DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2305-2026%22) Jan 31, 2025 FDA device enforcement ### [DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid Mov...](https://isitonrecall.com/recall/fda-device-z-1291-2025-deroyal-ref-71-c5100ns-tubing-suction-connector-deroyal-ref-71-c6100ns-tubing-suction-connector-dero/) Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. This size difference, combined with the durometer of the plastic material, makes the assembly to a suction canister lid port difficult. Th... Class II Reported ongoing Distribution: U.S.: IL, MN, NC, PA, and VA O.U.S.: N/A [Official source for DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connec...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1291-2025%22) Jan 15, 2025 FDA device enforcement ### [DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement](https://isitonrecall.com/recall/fda-device-z-1174-2025-deroyal-amg-suction-connector-tubing-ref-71-2083-71-c506-71-c510-71-c512-71-c520-tubing-is-intended/) The tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer connection for a tight seal. This could result in inadequate suction and cause delay in patient care. Class II Reported ongoing Distribution: U.S.: ND, NY, VA, WV, NJ, TN, OK, TN, GA, OH, MN, AZ, WI, IL, MA, MD, MO, AR, MS, NY, MS, SC, HI, AR, UT, HI, O.U.S.: Kuwait [Official source for DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1174-2025%22) Oct 3, 2024 FDA device enforcement ### [DeRoyal C-SECTION TRACEPACK, REF 89-9338-06](https://isitonrecall.com/recall/fda-device-z-0306-2025-deroyal-c-section-tracepack-ref-89-9338-06/) DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source ... Class II Reported ongoing Distribution: US Nationwide distribution in the state of OH. [Official source for DeRoyal C-SECTION TRACEPACK, REF 89-9338-06](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0306-2025%22) Oct 3, 2024 FDA device enforcement ### [DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06](https://isitonrecall.com/recall/fda-device-z-0307-2025-deroyal-children-s-general-tracepack-ref-89-9342-06/) DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source ... Class II Reported ongoing Distribution: US Nationwide distribution in the state of OH. [Official source for DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0307-2025%22) Oct 3, 2024 FDA device enforcement ### [DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06](https://isitonrecall.com/recall/fda-device-z-0308-2025-deroyal-children-s-orthopedic-tracepack-89-9349-06/) DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source ... Class II Reported ongoing Distribution: US Nationwide distribution in the state of OH. [Official source for DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0308-2025%22) Oct 3, 2024 FDA device enforcement ### [DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06](https://isitonrecall.com/recall/fda-device-z-0309-2025-deroyal-children-s-laptracepack-89-9362-06/) DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source ... Class II Reported ongoing Distribution: US Nationwide distribution in the state of OH. [Official source for DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0309-2025%22) Feb 13, 2024 FDA device enforcement ### [GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART](https://isitonrecall.com/recall/fda-device-z-1382-2024-geomed-custom-tracecarts-ref-numbers-a-53-1831-ortho-total-joint-tracecart-b-53-1836-general-surgery/) DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled. Class I Reported ongoing Distribution: Florida [Official source for GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1382-2024%22) Nov 22, 2023 FDA device enforcement ### [DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572](https://isitonrecall.com/recall/fda-device-z-0622-2024-deroyal-cardiac-cath-set-up-kit-pgybk-ref-89-10572/) Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences. Class II Reported ongoing Distribution: US: Virginia [Official source for DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0622-2024%22) Sep 18, 2023 FDA device enforcement ### [DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit](https://isitonrecall.com/recall/fda-device-z-0116-2024-deroyal-head-and-neck-procedure-kit-ref-89-4473-surgical-convenience-kit/) DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Medical Norm-Ject 2 Piece Syringe. The recall is due to the potential for the sterile packaging barrier to be damaged due to damage to the luer tip of the syringe. Class II Reported ongoing Distribution: Pennsylvania [Official source for DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0116-2024%22) May 30, 2023 FDA device enforcement ### [Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045; c) SHOULDER PACK, REF '89-10115; d) MINOR ORTHO PACK, REF ...](https://isitonrecall.com/recall/fda-device-z-2086-2023-custom-medical-procedure-packs-labeled-as-a-open-heart-tracecart-ref-53-1941-b-cardiac-cath-pack-ref/) The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2086-2023%22) May 30, 2023 FDA device enforcement ### [Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014](https://isitonrecall.com/recall/fda-device-z-2087-2023-custom-medical-procedure-packs-labeled-as-a-sturdi-strainer-tray-standard-ref-89-5014/) The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2087-2023%22) May 30, 2023 FDA device enforcement ### [Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF 89-7133 e) TOTAL H...](https://isitonrecall.com/recall/fda-device-z-2088-2023-custom-medical-procedure-packs-labeled-as-a-standard-ob-pack-ascension-wi-ref-89-10640-b-angio-pack/) The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGI...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2088-2023%22) May 30, 2023 FDA device enforcement ### [Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219](https://isitonrecall.com/recall/fda-device-z-2089-2023-custom-medical-procedure-packs-labeled-as-a-pelvic-exam-tray-ref-89-6219/) The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2089-2023%22) May 30, 2023 FDA device enforcement ### [Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183](https://isitonrecall.com/recall/fda-device-z-2090-2023-custom-medical-procedure-packs-labeled-as-a-cath-angiography-drape-pack-ref-89-7102-b-cholangiograph/) The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLAN...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2090-2023%22) Apr 17, 2023 FDA device enforcement ### [Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital; (3) 89-10509.02, ...](https://isitonrecall.com/recall/fda-device-z-1691-2023-sterile-custom-surgical-procedure-packs-1-89-10507-02-total-knee-pack-stonewall-jackson-hospital-2-8/) The custom procedure packs contain light handle covers that have been recalled by another firm. Class II Reported ongoing Distribution: US Nationwide distribution in the state of VA. [Official source for Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hosp...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1691-2023%22) Apr 17, 2023 FDA device enforcement ### [Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Mem...](https://isitonrecall.com/recall/fda-device-z-1692-2023-sterile-custom-surgical-procedure-packs-1-89-10529-04-cnrv-or-c-section-pack-new-river-valley-medica/) The custom procedure packs contain light handle covers that have been recalled by another firm. Class II Reported ongoing Distribution: US Nationwide distribution in the state of VA. [Official source for Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1692-2023%22) Feb 9, 2023 FDA device enforcement ### [DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B](https://isitonrecall.com/recall/fda-device-z-1283-2023-deroyal-safeliner-suction-canister-1000cc-ref-phesl-1000b/) The reason for the voluntary recall is due to shrinkage of the canister lid. This shrinkage causes the lid not to contact the outer shell to create a seal and thus, it does not create and hold vacuum. Class II Reported ongoing Distribution: US Nationwide distribution in the states of Arizona, Texas, Virginia, Pennsylvania, California, Missouri, North Carolina, Illinois, Indiana, Ohio, Arkansas. [Official source for DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1283-2023%22) Dec 12, 2022 FDA device enforcement ### [DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10](https://isitonrecall.com/recall/fda-device-z-0927-2023-deroyal-organ-recovery-pack-pgybk-a-ref-89-9004-09-and-b-89-9004-10/) DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the non-absorbable sutures that may cause a gap or wri... Class II Reported terminated Distribution: US Nationwide distribution in the states of IL, MO. [Official source for DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0927-2023%22) Nov 28, 2022 FDA device enforcement ### [DeRoyal Tonsillectomy Tray, REF 89-10698.01](https://isitonrecall.com/recall/fda-device-z-0906-2023-deroyal-tonsillectomy-tray-ref-89-10698-01/) DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall is due to ConMed receiving reports that the suction ports may be occluded on the affected devices. If ... Class II Reported terminated Distribution: Distribution in US states of VA, and SC. [Official source for DeRoyal Tonsillectomy Tray, REF 89-10698.01](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0906-2023%22) ## Reasons in these listed records - Sterile wound dressing, lacks sterility assurance - Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. This size difference, combined with the durometer of the plastic material, makes the assembly to a suction canister lid port difficult. This could result in i... - The tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer connection for a tight seal. This could result in inadequate suction and cause delay in patient care. - DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active af... These examples come from this result page and are not a ranking of every recall reason. ## Checking DeRoyal Industries Inc ### Is there a recall on deroyal industries inc right now? This archive contains 181 records, including 174 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 DeRoyal Industries Inc](https://isitonrecall.com/check/?q=DeRoyal%20Industries%20Inc) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)