DeRoyal Industries Inc

FDA recalling firm · 46 enforcement events · 226 product records · 2012–2026 · TN

DeRoyal Industries Inc has 46 FDA enforcement events on this register (226 product records) between 2012 and 2026: 46 device; the busiest year was 2022 with 6.

4% of its events are Class I; the most common class is Class II (43). 12 events are listed as ongoing; the recalling firm's address is in TN.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
18 May 2026	DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)	Device	Class II	1	Ongoing
31 Jan 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	Device	Class II	1	Ongoing
15 Jan 2025	DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement	Device	Class II	1	Ongoing
3 Oct 2024	DeRoyal C-SECTION TRACEPACK, REF 89-9338-06	Device	Class II	4	Ongoing
13 Feb 2024	GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART	Device	Class I	1	Ongoing
22 Nov 2023	DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572	Device	Class II	1	Ongoing
18 Sep 2023	DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit	Device	Class II	1	Ongoing
30 May 2023	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 PGYBK, REF '89-10505; f) ANTERIOR HIP PACK PGYBK, REF '89-10563; g) ORTHO X-RAY PACK, REF '89-1495; h) GU PACK,…	Device	Class II	5	Ongoing
17 Apr 2023	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 Hospital; (4) 89-10517.04, CNRV BASIC SETUP PACK, New River Valley Medical Center; (5) 89-10526.04, CNRV…	Device	Class II	2	Ongoing
9 Feb 2023	DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B	Device	Class II	1	Ongoing
12 Dec 2022	DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10	Device	Class II	1	Terminated
28 Nov 2022	DeRoyal Tonsillectomy Tray, REF 89-10698.01	Device	Class II	1	Terminated
3 Nov 2022	DeRoyal MINOR ORAL / ENT PACK, REF 89-2576.15	Device	Class II	156	Ongoing
12 Aug 2022	DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors	Device	Class II	1	Terminated
15 Jul 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 M8136; and (4) DeRoyal Security Cuffs, Heavy Duty Vertical Psychiatric, University, REF M8137.	Device	Class II	1	Terminated
3 Mar 2022	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.	Device	Class II	3	Terminated
14 May 2021	DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06	Device	Class I	3	Terminated
25 Jan 2021	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.	Device	Class II	3	Terminated
24 Apr 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, 89-6150.12 d. Umbilical Arterial Cath, 89-9370.01 e. Port Pack Pgybk, 89-8748.03 f. Port Pack Pgybk, 89-8748.04…	Device	Class II	1	Terminated
27 Feb 2020	DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.	Device	Class II	1	Terminated
21 Nov 2019	DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP	Device	Class II	1	Ongoing
22 Jul 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 Usage: Feeding tube	Device	Class II	1	Terminated
18 Jun 2019	DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack	Device	Class II	1	Terminated
17 Dec 2018	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	Device	Class II	1	Terminated
23 Apr 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	Device	Class II	1	Terminated
22 Jan 2018	Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy	Device	Class II	1	Terminated
19 Dec 2017	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) Shoulder Arthroscopy Pack 89-8686.02 (c) Knee Arthro Pack 89-8687.01 (d) Knee Arthro Pack 89-8687.02…	Device	Class II	1	Terminated
16 Oct 2017	DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and Drainage Tray, REF 47-763.04 b) Incision and Drainage Tray, REF 47-763.06 c) Incision and Drainage Tray, REF 47-763.07 d) Cricothyreotomy Ambulance Kit, REF 89-6752.01 e) Incision and Drainage Tray, REF 89-6818.02 f)…	Device	Class II	1	Terminated
7 Jun 2017	DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure.	Device	Class II	1	Terminated
25 Jan 2017	DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.	Device	Class III	2	Terminated
7 Nov 2016	TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis	Device	Class II	2	Terminated
11 Aug 2016	Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit.	Device	Class II	2	Terminated
14 Oct 2015	HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only.	Device	Class II	1	Terminated
10 Sep 2015	DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7859.01 2) Emergency CABG Pack Pgybk, ref 89-7859.02 3) Open Heart Pack A&B Pgybk, ref 89-7750.02 4) Open Heart Pack A&B Pgybk, ref 89-7750.03 5) Intl-Cardiac Surgery Pack A&B Pgybk, ref 89-8514.02 GEO-MED sterile custom surgical kits: 1) Open…	Device	Class II	1	Terminated
31 Aug 2015	DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: TOTAL KNEE A & B, REF 89-4561.11; TOTAL HIP A & B, REF 89-4562.12; PODIATRY TRAY, REF 89-3101.04; KNEE SCOPE PACK, REF 89-7744.03; KNEE PACK, REF 89-8194.02; BEACH CHAIR PACK, REF 89-8439.01;…	Device	Class II	2	Terminated
27 Apr 2015	Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ANGIO TRAY, REF 50-12127; NEURO SPINE TRAY, LAP CHOLE TRACECART(R), REF 53-1931; MINOR PROCEDURE TRACECART (R), REF 53-1932; MAJOR PROCEDURE TRACECART (R), 53-1933; Cover Light Handle Flexible, REF 5-3479-1; LAPAROSCOPY TRAY, REF 89-3605;…	Device	Class II	1	Terminated
17 Apr 2015	DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag indicated for use in laparoscopic procedures to capture and remove organs or tissue from the body cavity.	Device	Class II	1	Terminated
22 Aug 2014	Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. 2) NOVAPLUS(TM) SUCTION CANISTER, 1000 cc, SEMI-RIGID, Cat. No. V71-6510, NON-STERILE, Rx Only general hospital	Device	Class II	2	Terminated
4 Jun 2014	DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Manufacturer: DeRoyal Industries, Inc.	Device	Class II	2	Terminated
21 Feb 2014	DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product Usage: Limb holders are intended for mildly to moderate agitated or disoriented patients who disrupt medical treatment and/or cause harm to themselves and/or others	Device	Class II	1	Terminated
16 Jan 2014	DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.	Device	Class II	1	Terminated
17 Sep 2013	Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China. Physical Therapy.	Device	Class II	6	Terminated
12 Aug 2013	DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE IN GUATEMALA cleaning of fluids from surgical site in or near the eye	Device	Class II	1	Terminated
15 Jul 2013	DeRoyal Insufflation Tubing sets: 1) REF 28-0206 Insufflation Tubing, Laparoscopic Rx Only 2) REF 28-0214 Hi-Flow Insufflation Tubing Rx Only 3) REF 28-0216 Tubing, Insuf w/.3 Micr Filter Rx Only 4) REF 28-0217 Insufflation Tubing, Laparoscopic Rx Only 5) REF 28-0208 Insufflation Tubing w/Vent Rx Only 6) REF 28-0212H…	Device	Class II	1	Terminated
30 May 2013	GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical	Device	Class II	1	Terminated
16 Jun 2012	Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits	Device	Class II	1	Terminated

By type and class

Device46

Class II43

Class I2

Class III1

Class I: 4% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for DeRoyal Industries Inc by year initiated.

Questions and answers

How many FDA recalls has DeRoyal Industries Inc had?

46 enforcement events (226 product records) on this register, 2012–2026: 46 device.

Are any DeRoyal Industries Inc recalls ongoing?

12 events are listed as ongoing in the current openFDA export.

What class are DeRoyal Industries Inc recalls?

43 Class II, 2 Class I, 1 Class III. 4% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.