Food, drugs, devices › DeRoyal Industries Inc

Device recall: DeRoyal MINOR ORAL / ENT PACK, REF 89-2576.15

FDA enforcement event 91134 · Class II · initiated 3 Nov 2022 · status Ongoing

DeviceVoluntary: Firm initiated156 product recordsPowell, TN

FDA enforcement event 91134 is a device recall by DeRoyal Industries Inc of Powell, TN, initiated 3 Nov 2022 and classified Class II, with 156 product records.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. DeRoyal Industries Inc has 46 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

DeRoyal Industries Inc, Powell, TN.

Reason for recall

"XXX"

Distribution

"US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana,…"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0560-2023	DeRoyal MINOR ORAL / ENT PACK, REF 89-2576.15	78 kits	Class II	Ongoing	21 Dec 2022
Z-0561-2023	DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15	828 kits	Class II	Ongoing	21 Dec 2022
Z-0562-2023	DeRoyal EYE PACK, REF 89-4051.09	156 kits	Class II	Ongoing	21 Dec 2022
Z-0563-2023	DeRoyal EXTREMITY TRAY PGYBK, REF 89-4081.07	130 kits	Class II	Ongoing	21 Dec 2022
Z-0564-2023	DeRoyal EYE TRAY, REF 89-4957.08	48 kits	Class II	Ongoing	21 Dec 2022
Z-0565-2023	DeRoyal PEDI ORTHO PACK, REF 89-5323.20	27 kits	Class II	Ongoing	21 Dec 2022
Z-0566-2023	GEO-MED KNEE ARTHROSCOPY PACK, REF 89-5795.07	4 units	Class II	Ongoing	21 Dec 2022
Z-0567-2023	GEO-MED TOTAL KNEE PACK A & B PGYK, REF 89-5796.13	79 units	Class II	Ongoing	21 Dec 2022
Z-0568-2023	GEO-MED SHOULDER ARTHROSCOPY KNEE PACK, REF 89-5797.09	135 kits	Class II	Ongoing	21 Dec 2022
Z-0569-2023	DeRoyal PICC LINE TRAY PGYBK, REF 89-6150.13	918 kits	Class II	Ongoing	21 Dec 2022
Z-0570-2023	GEO-MED PODIATRY PACK PGYBK, REF 89-6240.05	184 kits	Class II	Ongoing	21 Dec 2022
Z-0571-2023	GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.08	90 kits	Class II	Ongoing	21 Dec 2022
Z-0572-2023	GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.09	30 kits	Class II	Ongoing	21 Dec 2022
Z-0573-2023	DeRoyal SHOULDER ARTHORSCOPY PACK RF, REF 89-6628.09	144 kits	Class II	Ongoing	21 Dec 2022
Z-0574-2023	DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.07	3 kits	Class II	Ongoing	21 Dec 2022
Z-0575-2023	DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.09	42 kits	Class II	Ongoing	21 Dec 2022
Z-0576-2023	GEO-MED PLASTIC HAND PACK RF, REF 89-6667.09	165 kits	Class II	Ongoing	21 Dec 2022
Z-0577-2023	GEO-MED PLASTIC HAND PACK RF, REF 89-6667.10	102 kits	Class II	Ongoing	21 Dec 2022
Z-0578-2023	GEO-MED TOTAL KNEE PACK A & B, REF 89-6799.02	49 kits	Class II	Ongoing	21 Dec 2022
Z-0579-2023	DeRoyal SHOULDER PACK, REF 89-6830.13	876 kits	Class II	Ongoing	21 Dec 2022
Z-0580-2023	DeRoyal CATARACT PACK CSM, REF 89-6863	1220 kits	Class II	Ongoing	21 Dec 2022
Z-0581-2023	DeRoyal CANNULTED HIP PACK CSM, REF 89-6977.09	108 kits	Class II	Ongoing	21 Dec 2022
Z-0582-2023	DeRoyal CANNULTED HIP PACK, REF 89-6977.10	36 kits	Class II	Ongoing	21 Dec 2022
Z-0583-2023	DeRoyal BREAST TRAY, REF 89-7033.07	162 kits	Class II	Ongoing	21 Dec 2022
Z-0584-2023	DeRoyal LAPAROSCOPIC ROBOTIC TRAY, REF 89-7063.11	30 kits	Class II	Ongoing	21 Dec 2022
Z-0585-2023	DeRoyal GU ROBOTIC PACK, REF 89-7063.12	192 kits	Class II	Ongoing	21 Dec 2022
Z-0586-2023	DeRoyal CATARACT PACK, REF 89-7135.10	190 kits	Class II	Ongoing	21 Dec 2022
Z-0587-2023	DeRoyal TRANS CANAL PACK, REF 89-7157.12	156 kits	Class II	Ongoing	21 Dec 2022
Z-0588-2023	DeRoyal LAPINECTOMY PACK, REF 89-7198.10	403 kits	Class II	Ongoing	21 Dec 2022
Z-0589-2023	DeRoyal LAPINECTOMY PACK, REF 89-7198.11	715 kits	Class II	Ongoing	21 Dec 2022
Z-0590-2023	DeRoyal BASIC NEURO PACK, REF 89-7258.10	108 kits	Class II	Ongoing	21 Dec 2022
Z-0591-2023	DeRoyal BASIC NEURO PACK, REF 89-7258.12	96 kits	Class II	Ongoing	21 Dec 2022
Z-0592-2023	DeRoyal BASIC NEURO PACK, REF 89-7258.13	216 kits	Class II	Ongoing	21 Dec 2022
Z-0593-2023	DeRoyal VIT RD PACK 86ST, REF 89-7308.09	16 kits	Class II	Ongoing	21 Dec 2022
Z-0594-2023	DeRoyal RETINAL PACK, REF 89-7336.07	64 kits	Class II	Ongoing	21 Dec 2022
Z-0595-2023	DeRoyal CUSTOM NEURO PACK, REF 89-7353.17	36 kis	Class II	Ongoing	21 Dec 2022
Z-0596-2023	DeRoyal SPINAL FUSION PACK, REF 89-7515.12	27 kits	Class II	Ongoing	21 Dec 2022
Z-0597-2023	DeRoyal SPINAL FUSION PACK, REF 89-7515.13	16 kits	Class II	Ongoing	21 Dec 2022
Z-0598-2023	DeRoyal SPINAL FUSION PACK, REF 89-7515.14	30 kits	Class II	Ongoing	21 Dec 2022
Z-0599-2023	DeRoyal BASIC NEURO PACK, REF 89-7523.15	288 kits	Class II	Ongoing	21 Dec 2022
Z-0600-2023	DeRoyal BASIC NEURO PACK, REF 89-7523.16	304 kits	Class II	Ongoing	21 Dec 2022
Z-0601-2023	DeRoyal ORTHO SPINE BACK PACK, REF 89-7534.09	264 kits	Class II	Ongoing	21 Dec 2022
Z-0602-2023	DeRoyal ENDOVENOUS PACK, REF 89-7762.05	88 kits	Class II	Ongoing	21 Dec 2022
Z-0603-2023	DeRoyal EYE TRAY PGYBK, REF 89-7978.02	180 kits	Class II	Ongoing	21 Dec 2022
Z-0604-2023	GEO-MED LOWER EXTERMITY PACK, REF 89-8252.02	48 kits	Class II	Ongoing	21 Dec 2022
Z-0605-2023	GEO-MED UPPER EXTERMITY PACK, REF 89-8253.02	243 kits	Class II	Ongoing	21 Dec 2022
Z-0606-2023	DeRoyal BASIC EYE PACK, REF 89-8337.08	45 kits	Class II	Ongoing	21 Dec 2022
Z-0607-2023	DeRoyal BASIC EYE PACK, REF 89-8337.09	50 kits	Class II	Ongoing	21 Dec 2022
Z-0608-2023	DeRoyal HEART PACK, REF 89-8351.11	240 kits	Class II	Ongoing	21 Dec 2022
Z-0609-2023	DeRoyal HEART PACK, REF 89-8351.12	102 kits	Class II	Ongoing	21 Dec 2022
Z-0610-2023	DeRoyal HEART PACK, REF 89-8351.13	51 kits	Class II	Ongoing	21 Dec 2022
Z-0611-2023	DeRoyal PODIATRY PACK, REF 89-8359.10	186 kits	Class II	Ongoing	21 Dec 2022
Z-0612-2023	DeRoyal PODIATRY PACK, REF 89-8359.13	102 kits	Class II	Ongoing	21 Dec 2022
Z-0613-2023	DeRoyal SPINE PACK, REF 89-8361.08	243 kits	Class II	Ongoing	21 Dec 2022
Z-0614-2023	DeRoyal SPINE PACK, REF 89-8361.09	144 kits	Class II	Ongoing	21 Dec 2022
Z-0615-2023	DeRoyal SPINE PACK, REF 89-8361.10	96 kits	Class II	Ongoing	21 Dec 2022
Z-0616-2023	DeRoyal CUSTOM NEURO PACK, REF 89-8392.09	12 kits	Class II	Ongoing	21 Dec 2022
Z-0617-2023	DeRoyal CUSTOM NEURO PACK, REF 89-8392.10	12 kits	Class II	Ongoing	21 Dec 2022
Z-0618-2023	DeRoyal BASIC PACK, REF 89-8633.07	130 kits	Class II	Ongoing	21 Dec 2022
Z-0619-2023	GEO-MED PODIATRY PACK PGYBK, REF 89-8700.01	76 kits	Class II	Ongoing	21 Dec 2022

Showing 60 of 156 product records; the FDA enforcement report lists all of them.

Context

88%of 2022 device events are Class II839 events that year

156product records in this eventfirm median: 1

46events on this register for the firm

Other enforcement events for DeRoyal Industries Inc

Initiated	Product (first record)	Type	Class	Records
18 May 2026	DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)	Device	Class II	1
31 Jan 2025	DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C71	Device	Class II	1
15 Jan 2025	DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid move	Device	Class II	1
3 Oct 2024	DeRoyal C-SECTION TRACEPACK, REF 89-9338-06	Device	Class II	4
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
22 Nov 2023	DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572	Device	Class II	1
18 Sep 2023	DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit	Device	Class II	1
30 May 2023	Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045; c	Device	Class II	5
17 Apr 2023	Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02,	Device	Class II	2
9 Feb 2023	DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B	Device	Class II	1

All 46 events for DeRoyal Industries Inc

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "XXX"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana,…"

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.