Manufacturer

DeRoyal Industries Inc

182 recalls in our database name DeRoyal Industries Inc as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 182

HighFDA (Devices)·Z-1291-2025·2025-03-12
DeRoyal Suction Connector Tubing Recalled for Assembly and Function Issues
DeRoyal suction connector tubing in five U.S. states has been recalled because the connector's inner diameter is smaller than the suction canister lid port, making assembly difficult and risking inadequate suction and delayed patient care.
Product
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
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1174-2025·2025-02-26
DeRoyal AMG Suction Connector Tubing connection may fail to seal
DeRoyal Industries is recalling AMG Suction Connector Tubing because the connection between the tubing and suction device may not seal properly, potentially affecting patient care.
Product
DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement
Category
Medical Device
Distribution
21 states
HighFDA (Devices)·Z-0309-2025·2024-11-13
DeRoyal Surgical Procedure Pack Smoke Evacuation Pencil Recalled
DeRoyal is recalling surgical procedure pack products containing a Stryker SafeAir Smoke Evacuation Pencil that may activate without manual input or remain active after buttons are released. The malfunction poses a risk of injury during surgical procedures.
Product
DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0308-2025·2024-11-13
DeRoyal Children's Orthopedic Tracepack Smoke Evacuation Pencil Malfunction Recall
DeRoyal is recalling 384 units of Children's Orthopedic TracePacks containing a Stryker smoke evacuation pencil that may activate unexpectedly or fail to deactivate, posing a burn risk during surgery.
Product
DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0307-2025·2024-11-13
DeRoyal Children's Surgical Pack Recalled for Smoke Pencil Malfunction
DeRoyal is recalling certain lots of children's surgical procedure packs due to reports that the included Stryker smoke evacuation pencil may activate without manual input or remain active after buttons are released.
Product
DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1382-2024·2024-04-03
Surgical Tracecarts Recalled Due to Defective Foley Catheter Component
DeRoyal Industries is recalling 134 GeoMed Custom Tracecarts distributed in Florida that contain a recalled Foley catheter component. Affected units carry specific lot numbers with expiration dates from February 2024 through May 2025.
Product
GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0622-2024·2024-01-03
DeRoyal Cardiac Cath Kit Recalled for Defective Pressure Transducers
DeRoyal Industries is recalling a cardiac catheterization kit that contains Edwards Life Sciences pressure transducers that were subject to a separate recall by their manufacturer.
Product
DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0116-2024·2023-10-25
DeRoyal Head and Neck Surgical Kits Recalled for Damaged Syringe Luer Tip
DeRoyal Industries is recalling 32 surgical procedure kits containing syringes with potentially damaged luer tips that could compromise the sterile packaging barrier. The kits were distributed in Pennsylvania.
Product
DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2086-2023·2023-07-12
Medical procedure packs recalled for compromised package seals
DeRoyal Industries is recalling 4,225 custom medical procedure packs nationwide because outer package seals may be open or compromised, potentially affecting sterility of the surgical materials inside.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2088-2023·2023-07-12
Medical Procedure Packs with Compromised Package Seals Recalled
DeRoyal Industries is recalling 328 surgical procedure packs because outer package seals could be open or compromised, affecting product sterility. The affected packs are used in operating rooms nationwide.
Product
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-SECTION PACK, REF 89-9478
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2089-2023·2023-07-12
DeRoyal Pelvic Exam Trays Recalled Due to Compromised Package Seals
DeRoyal Industries is recalling 3 packs of Pelvic Exam Trays because the outer package seals may be open or compromised, potentially affecting the sterility of the medical procedure packs.
Product
Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2087-2023·2023-07-12
Custom Medical Procedure Packs Recalled for Compromised Package Seals
DeRoyal Industries is recalling 40 units of STURDI STRAINER TRAY STANDARD procedure packs nationwide due to potentially compromised outer package seals that could affect sterility.
Product
Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2090-2023·2023-07-12
Custom Medical Procedure Packs Recalled for Compromised Package Seals
DeRoyal Industries is recalling 306 custom medical procedure packs because the outer package seals could be open or compromised, affecting the sterility of the contents. Affected packs were distributed nationwide.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1691-2023·2023-06-14
Sterile Surgical Procedure Packs Recalled for Defective Light Handle Covers
DeRoyal Industries is recalling 2,972 sterile surgical procedure packs containing light handle covers that have been recalled by another manufacturer. The affected packs were distributed to hospitals in Virginia.
Product
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 Va
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1692-2023·2023-06-14
Surgical Procedure Packs Recalled Due to Included Light Handle Covers
DeRoyal Industries is recalling two models of custom surgical procedure packs because they contain light handle covers that were previously recalled by another manufacturer. The packs were distributed in Virginia.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1283-2023·2023-03-29
DeRoyal Suction Canister Recalled Due to Lid Shrinkage Seal Defect
DeRoyal SafeLiner Suction Canister model PHESL-1000B is being recalled due to lid shrinkage that prevents proper vacuum seal formation and maintenance. The recall affects 27,200 devices distributed across multiple US states.
Product
DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0927-2023·2023-01-18
DeRoyal surgical procedure pack recalled for sterile barrier defect
DeRoyal is recalling certain surgical procedure packs containing Medtronic non-absorbable sutures due to a manufacturing error that may breach the sterile barrier protecting the surgical field.
Product
DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0906-2023·2023-01-11
DeRoyal Tonsillectomy Tray recalled for potential suction port occlusion
DeRoyal is recalling certain Tonsillectomy Tray lots due to potential blockage of suction ports in the integrated electrosurgical suction coagulator. The defect may prevent proper suction function during surgical procedures.
Product
DeRoyal Tonsillectomy Tray, REF 89-10698.01
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0629-2023·2022-12-21
Medical Device: DeRoyal HEART B PACK Recalled by FDA
DeRoyal Industries initiated a Class II recall of its HEART B PACK medical device kit affecting 68 units distributed across 23 US states (Lot 56613762, expires 6/1/2026). The specific reason for recall is not available in source documentation.
Product
DeRoyal KIT HEART B PACK, REF 89-9042.07
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0651-2023·2022-12-21
Medical device shoulder pack recalled by DeRoyal Industries
DeRoyal Industries recalled 48 units of its shoulder pack medical device (Lot 57755295) on November 3, 2022. The specific reason for the recall was not disclosed in available documentation.
Product
DeRoyal SHOULDER PACK, REF 89-9449.13
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0692-2023·2022-12-21
FDA Class II Recall of DeRoyal Posterior Spine Surgical Packs
DeRoyal Industries voluntarily recalled 1,196 posterior spine surgical packs distributed across 23 states. The specific reason for the recall was not documented.
Product
DeRoyal CMC POSTERIOR SPINE PACK, REF 89-10570.01
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0569-2023·2022-12-21
DeRoyal PICC line trays recalled due to sterile drape defects
DeRoyal Industries is recalling 918 PICC line procedure packs containing 3M sterile drapes that were separately recalled. The affected kits were distributed across 23 U.S. states to healthcare facilities.
Product
DeRoyal PICC LINE TRAY PGYBK, REF 89-6150.13
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0591-2023·2022-12-21
DeRoyal procedure packs recalled for containing affected Steri Drapes
DeRoyal Industries is recalling its BASIC NEURO PACK procedure packs because they contain 3M Health Care Steri Drapes that have been recalled. The recall affects 96 kits (lot 57287655, expires 9/1/2026) distributed to 23 states.
Product
DeRoyal BASIC NEURO PACK, REF 89-7258.12
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0662-2023·2022-12-21
FDA Class II Recall: DeRoyal BIOPSY PACK Medical Device
DeRoyal Industries has recalled 480 units of its BIOPSY PACK (REF 89-9614.07) in a voluntary, firm-initiated recall affecting 23 US states. The specific reason for the recall has not been disclosed.
Product
DeRoyal BIOPSY PACK, REF 89-9614.07
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0580-2023·2022-12-21
DeRoyal Cataract Procedure Packs Recalled Due to Defective Sterile Drapes
DeRoyal Industries is recalling approximately 1,220 cataract procedure packs that contain recalled 3M Health Care Steri Drapes. The affected kits were distributed to healthcare facilities across 23 U.S. states.
Product
DeRoyal CATARACT PACK CSM, REF 89-6863
Category
Medical Device
Distribution
0 states