Drug & Device Safety Atlas

FDA recall record · openFDA

DeRoyal Industries Inc

18 FDA recalls on record (2023–2026) — 18 device. 18 still ongoing.

1
Class I (most serious)
17
Class II
0
Class III
18
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. 5
DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pe 4
The custom procedure packs contain light handle covers that have been recalled by another firm. 2
The tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer connection for a tight sea 1
Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subs 1

Recalls

GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART Class I 2024-02-13 DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm) Class II 2026-05-18 DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fl Class II 2025-01-15 DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C Class II 2025-01-31 DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06 Class II 2024-10-03 DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06 Class II 2024-10-03 DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06 Class II 2024-10-03 DeRoyal C-SECTION TRACEPACK, REF 89-9338-06 Class II 2024-10-03 Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; an Class II 2023-04-17 DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572 Class II 2023-11-22 Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, RE Class II 2023-05-30 Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89- Class II 2023-05-30 Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014 Class II 2023-05-30 DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B Class II 2023-02-09 Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219 Class II 2023-05-30 Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508. Class II 2023-04-17 DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit Class II 2023-09-18 Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-1090 Class II 2023-05-30

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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