Powell, TN, United States
DeRoyal Industries Inc recalls
28 recalls recorded since 2018, most recently on 20 August 2026. 13 are listed as ongoing. Status and classification are as published by the FDA.
Recalls28
Ongoing (FDA)13
Terminated or completed15
Class I (FDA)2
Ongoing Class II Medical devices
- Recall started
- 20 August 2026
- Reason
- Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
- Distribution
- US Nationwide distribution in the states of LA,MO, MD, TN, UT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3256-2026
- REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
Ongoing Class II Medical devices
- Recall started
- 18 May 2026
- Reason
- Sterile wound dressing, lacks sterility assurance
- Distribution
- US Nationwide distribution in the states of FL & NC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2305-2026
- DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
Ongoing Class II Medical devices
- Recall started
- 31 January 2025
- Reason
- 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 inadequate suction and cause a delay in patient care.
- Distribution
- U.S.: IL, MN, NC, PA, and VA O.U.S.: N/A
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1291-2025
- DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid Movement
Ongoing Class II Medical devices
- Recall started
- 15 January 2025
- Reason
- 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.
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1174-2025
- DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement
Ongoing Class II Medical devices
- Recall started
- 3 October 2024
- Reason
- 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 after buttons are released.
- Distribution
- US Nationwide distribution in the state of OH.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0309-2025, Z-0308-2025, Z-0307-2025, Z-0306-2025
- DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
- DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
- DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
- DeRoyal C-SECTION TRACEPACK, REF 89-9338-06
Ongoing Class I Medical devices
- Recall started
- 13 February 2024
- Reason
- DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled.
- Distribution
- Florida
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1382-2024
- GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART
Ongoing Class II Medical devices
- Recall started
- 22 November 2023
- Reason
- Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.
- Distribution
- US: Virginia
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0622-2024
- DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
Ongoing Class II Medical devices
- Recall started
- 18 September 2023
- Reason
- 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.
- Distribution
- Pennsylvania
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0116-2024
- DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
Ongoing Class II Medical devices
- Recall started
- 30 May 2023
- Reason
- The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2090-2023, Z-2086-2023, Z-2087-2023, Z-2089-2023, Z-2088-2023
- 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
- 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 '89-10213; e) TOTAL KNEE PACK
- Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014
- Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219
- 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 HIP PACK, REF 89-9134 f) EMERGENCY C
Ongoing Class II Medical devices
- Recall started
- 17 April 2023
- Reason
- The custom procedure packs contain light handle covers that have been recalled by another firm.
- Distribution
- US Nationwide distribution in the state of VA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1692-2023, Z-1691-2023
- 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 Memorial Hospital.
- 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, LAPAROTOMY PACK, Stonewall Jackson Hos
Ongoing Class II Medical devices
- Recall started
- 9 February 2023
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of Arizona, Texas, Virginia, Pennsylvania, California, Missouri, North Carolina, Illinois, Indiana, Ohio, Arkansas.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1283-2023
- DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
Terminated Class II Medical devices
- Recall started
- 12 December 2022
- Terminated
- 29 May 2026
- Reason
- 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 wrinkle in the breather seal resulting in a sterile barrier breach.
- Distribution
- US Nationwide distribution in the states of IL, MO.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0927-2023
- DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
Terminated Class II Medical devices
- Recall started
- 28 November 2022
- Terminated
- 18 March 2026
- Reason
- 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 this occurs, the affected devices will not be able to perform the suction function during use.
- Distribution
- Distribution in US states of VA, and SC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0906-2023
- DeRoyal Tonsillectomy Tray, REF 89-10698.01
Ongoing Class II Medical devices
- Recall started
- 3 November 2022
- Reason
- XXX
- Distribution
- US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0647-2023, Z-0659-2023, Z-0593-2023, Z-0640-2023, Z-0688-2023, Z-0655-2023, Z-0582-2023, Z-0587-2023, Z-0668-2023, Z-0580-2023, Z-0629-2023, Z-0707-2023 and 144 more
- DeRoyal MYELOGRAM PACK, REF 89-9304.05
- DeRoyal LUMBAR/CERVICAL PACK, REF 89-9521.11
- DeRoyal VIT RD PACK 86ST, REF 89-7308.09
- DeRoyal FOOT PACK, REF 89-9252.08
- DeRoyal PAIN TRAY, REF 89-10464.03
- DeRoyal SHOULDER KIT, REF 89-9497.08
- DeRoyal CANNULTED HIP PACK, REF 89-6977.10
- DeRoyal TRANS CANAL PACK, REF 89-7157.12
- and 148 more product lines
Terminated Class II Medical devices
- Recall started
- 12 August 2022
- Terminated
- 20 September 2024
- Reason
- Procedure packs contained a recalled product.
- Distribution
- US Nationwide distribution in the states of OH and TN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1668-2022
- DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
Terminated Class II Medical devices
- Recall started
- 15 July 2022
- Terminated
- 6 August 2024
- Reason
- The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure.
- Distribution
- US Nationwide distribution in the states of FL, IN, NV, RI, TN, TX, and WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1562-2022
- DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle, Fixed, Quick Release, REF M8125; (3) DeRoyal Security Cuffs, Wrist and Ankle, Universal, REF M81
Terminated Class II Medical devices
- Recall started
- 3 March 2022
- Terminated
- 15 September 2022
- Reason
- A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
- Distribution
- US distribution to Florida, New Jersey, and Tennessee
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0879-2022, Z-0878-2022, Z-0880-2022
- DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
- DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
- DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
Terminated Class I Medical devices
- Recall started
- 14 May 2021
- Terminated
- 21 April 2023
- Reason
- DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine
- Distribution
- US Nationwide distribution to the states of MS, VA, LA, and NY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1834-2021, Z-1833-2021, Z-1832-2021
- DeRoyal Angio Cath Removal Tray, REF 89-9936.02
- DeRoyal Heart Cath Procedure Pack, REF 89-6556.08
- DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06
Terminated Class II Medical devices
- Recall started
- 25 January 2021
- Terminated
- 21 July 2022
- Reason
- Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.
- Distribution
- Distributors in OK, MI, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1139-2021, Z-1138-2021, Z-1140-2021
- Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs including sternum saw blades.
- CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.15 f) 89-7935.16 Custom surgical procedure packs including sternum saw blades.
- Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure packs including sternum saw blades.
Terminated Class II Medical devices
- Recall started
- 24 April 2020
- Terminated
- 26 May 2022
- Reason
- DeRoyal manufactured procedure packs using BDPosiFlush syringes which were subsequently recalled due holes in the packaging.
- Distribution
- US distribution in the states of TN, MD, MN, ND, NY, FL, MA, RI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1963-2020
- DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows: a. H* Vein Pack Pgybk, 89-6209.03 b. H* Vein Pack, 89-6209.04 c. PICC Line Tray Pgybk, 89-
Terminated Class II Medical devices
- Recall started
- 27 February 2020
- Terminated
- 10 May 2022
- Reason
- One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device.
- Distribution
- VA, CA, FL, AZ
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1604-2020
- DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.
Ongoing Class II Medical devices
- Recall started
- 21 November 2019
- Reason
- The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking.
- Distribution
- Nationwide, Australia, India, Saudi Arabia
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0706-2020
- DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP
Terminated Class II Medical devices
- Recall started
- 22 July 2019
- Terminated
- 14 December 2020
- Reason
- Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the connector has detached from the feeding tube.
- Distribution
- US Nationwide Distribution in the states of N, TX, IL OH, NM, UT. NB, KY, CO
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2293-2019
- DeRoyal Enteral Safe Feeding Tubes: a) REF 54-2450R, 5 FR x 24" Polyurethane b) REF 54-2465R, 6.5 FR x 24" Polyurethane c) REF 54-2480R, 8 FR x 24" Polyurethane d) REF 54-3680R, 8 FR x 36" Polyurethane Product Usa
Terminated Class II Medical devices
- Recall started
- 18 June 2019
- Terminated
- 16 September 2020
- Reason
- Custom surgical packs are being recalled because it contains Cardinal Health Blunt Cannulas which were recalled due to a manufacturing defect in the cartridge component which could compromise the sterility barrier of the product.
- Distribution
- US Distribution to: OK
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1981-2019
- DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack
Terminated Class II Medical devices
- Recall started
- 17 December 2018
- Terminated
- 16 December 2020
- Reason
- Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes.
- Distribution
- US distribution to states of: TX and UT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0746-2019
- DeRoyal(R) Enteral Safe Feed Tube, REF 54-2465 A Nasogastric/Oralgastric enteral feeding tube. The MED-RX Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician
Terminated Class II Medical devices
- Recall started
- 23 April 2018
- Terminated
- 9 November 2018
- Reason
- Non-sterile product was packaged inside a case that was labeled as sterile.
- Distribution
- Honduras, Belgium, and The Netherlands
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1583-2018
- DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF 88-001502 Product Usage: general surgical
Terminated Class II Medical devices
- Recall started
- 22 January 2018
- Terminated
- 19 August 2020
- Reason
- DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valve, which were subsequently recalled by Terumo CVS due to reports of 'No Flow' through the OPS valve.
- Distribution
- US Distribution to: NY
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0637-2018
- Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy
Terminated Class II Medical devices
- Recall started
- 19 December 2017
- Terminated
- 21 June 2018
- Reason
- DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tray with Piston Syringe that contains the Medline Aplicare Povidone Iodine Prep Pads. The Prep Pads were subsequently recalled because Medline Aplicare determined the product would not support the 36 month expiration date listed on the label.
- Distribution
- Distributed to states of: CA and MO.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0334-2018
- DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, labeled as follows: (a) Shoulder Arthroscopy Pack 89-8686.01 (b) Shou
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.