Facility

DEROYAL INDUSTRIES, INC.

47 recall(s) on record — most severe on record: Class I.

Key facts

47recalls · worst Class I

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3003040625
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	1595 Highway 33 S NEW TAZEWELL, TN, US 37825
Registration status	Active · expires 2026
Parent company	DEROYAL INDUSTRIES, INC. (owner-operator 1044833)
Brand names	Collector, Urine, (and Accessories) for Indwell Cath/ Tray, Catheteriz, Sterile Urethral, w/wo Catheter (kit)- DeRoyal

Activity by year

Recalls (47)
Inspections (1)

Devices registered here (2)

Collector, Urine, (And Accessories) For Indwelling Catheter
Product code KNX (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5250
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Product code FCM (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5130

Recalls & enforcement

20262 records

Class IIOngoing2026-08-20
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
Class IIOngoing2026-05-18
Sterile wound dressing, lacks sterility assurance

20252 records

Class IIOngoing2025-01-31
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 inad…
Class IIOngoing2025-01-15
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.

20242 records

Class IIOngoing2024-10-03
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…
Class IOngoing2024-02-13
DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled.

20235 records

Class IIOngoing2023-11-22
Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.
Class IIOngoing2023-09-18
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 IIOngoing2023-05-30
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
Class IIOngoing2023-04-17
The custom procedure packs contain light handle covers that have been recalled by another firm.
Class IIOngoing2023-02-09
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.

20226 records

Class IITerminated2022-12-12
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 se…
Class IITerminated2022-11-28
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 affect…
Class IIOngoing2022-11-03
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Class IITerminated2022-08-12
Procedure packs contained a recalled product.
Class IITerminated2022-07-15
The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure.
Class IITerminated2022-03-03
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.

20212 records

Class ITerminated2021-05-14
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
Class IITerminated2021-01-25
Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.

20202 records

Class IITerminated2020-04-24
DeRoyal manufactured procedure packs using BDPosiFlush syringes which were subsequently recalled due holes in the packaging.
Class IITerminated2020-02-27
One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device.

20193 records

Class IIOngoing2019-11-21
The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking.
Class IITerminated2019-07-22
Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the connector has detached from the feeding tube.
Class IITerminated2019-06-18
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.

20183 records

Class IITerminated2018-12-17
Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes.
Class IITerminated2018-04-23
Non-sterile product was packaged inside a case that was labeled as sterile.
Class IITerminated2018-01-22
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.

20174 records

Class IITerminated2017-12-19
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…
Class IITerminated2017-10-16
Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled by Medline Industries for incorrect expiration date.
Class IITerminated2017-06-07
Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility
Class IIITerminated2017-01-25
DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage product which was subsequently recalled due to the current packaging configuration of the Atrium Ocean, Oasis, Express and Express Mini chest drainage products.

20162 records

Class IITerminated2016-11-07
DeRoyal received complaints of mold on Tennis Elbow Straps.
Class IITerminated2016-08-11
The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. The BARD(TM) component is being recalled for a possible slit defect on the package that may affect the component's ste…

20155 records

Class IITerminated2015-10-14
DeRoyal manufactured four lots of HNICU-32, Hydro-Temp(R) Neonatal Temperature Skin Sensor incorrectly. The pins contained in the probe were soldered incorrectly. When probe is connected to the proper port, this defect results in the inability to read or display temperatures on t…
Class IITerminated2015-09-10
These custom sterile surgical kits contain the component, ECOLAB ORS Fluid Warming and Slush Drape, which was recalled due to the possibility that the sterile packaging may contain small channels in the seal of the pouch.
Class IITerminated2015-08-31
Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot Number 2016-09EE which was recalled due to unintended exposure to the sterilant during package sterilization.
Class IITerminated2015-04-27
Surgical kits contain Medtronic Covidien Devon(TM) Light Gloves which were recalled for splits or holes
Class IITerminated2015-04-17
The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use.

20144 records

Class IITerminated2014-08-22
These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition.
Class IITerminated2014-06-04
The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.
Class IITerminated2014-02-21
Moldy smell in product
Class IITerminated2014-01-16
Three lots of circumcision clamps were manufactured out of specification and as a result may not properly clamp at the surgical site completely.

20134 records

Class IITerminated2013-09-17
The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the t…
Class IITerminated2013-08-12
One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product.
Class IITerminated2013-07-15
DeRoyal Industries is recalling their product Insufflation Tubing Sets due to materials incompatibility which could possibly result in occlusion at or near the filter housing which could prevent the flow of gas through the device.
Class IITerminated2013-05-30
DeRoyal recalled kits that contained Stryker togas which were recalled for a potential problem with sterilization.

20121 record

Class IITerminated2012-06-16
Surgical kits and trays contain Stryker Hytrel Togas which were recalled because the clear tape, that is intended to aid in the prevention of patient's fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing …

FDA inspections (1)

NAI2017-07-25
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “DEROYAL INDUSTRIES, INC. (FEI 3003040625) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003040625-deroyal-industries-inc/

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