The Recall Desk

Manufacturer

DeRoyal Industries Inc

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

What the numbers show

Total
226
Critical
0
Severe
12
Most recent
2026-06-10

Of the 226 recalls from DeRoyal Industries Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 12 (5%) are Severe.

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.

176–200 of 226

  • ModerateFDA (Devices)·Z-0617-2023·2022-12-21

    FDA Class II Recall of DeRoyal CUSTOM NEURO PACK, Voluntary

    DeRoyal Industries Inc is voluntarily recalling the DeRoyal CUSTOM NEURO PACK (Lot 57745880) distributed across multiple U.S. states. The specific reason for the recall is not disclosed.

    Product
    DeRoyal CUSTOM NEURO PACK, REF 89-8392.10
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-1668-2022·2022-09-07

    DeRoyal Sterile Custom Kits Recalled for Defective Connectors

    DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors are being recalled because the procedure packs contained a recalled product. Approximately 1,306 kits were distributed in Ohio and Tennessee.

    Product
    DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1562-2022·2022-08-31

    DeRoyal Limb Holders and Security Cuffs Buckle Webbing Strap Failure

    DeRoyal is recalling specific limb holders and security cuffs due to improperly laced webbing straps that may slide loose, potentially compromising device security.

    Product
    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 Psy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0879-2022·2022-04-13

    DeRoyal Ultra/Mammo Tray Medical Kits Recalled for Unvalidated Manufacturing Test Methods

    DeRoyal Industries is recalling 780 Ultra/Mammo Tray kits with antiseptic swabs due to uncertain validation of manufacturing test methods. Kits are used for patient skin preparation before surgery or injection.

    Product
    DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0878-2022·2022-04-13

    DeRoyal ST Neonatal Dressing Change Kit recalled for unvalidated manufacturing test methods

    DeRoyal Industries is recalling 400 DeRoyal ST Neonatal Dressing Change Kits due to uncertain validation of manufacturing test methods. The recall affects kits distributed to healthcare facilities in Florida, New Jersey, and Tennessee.

    Product
    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.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0880-2022·2022-04-13

    DeRoyal DEXMED Access Center Tray Recalled for Manufacturing Test Validation Uncertainty

    DeRoyal Industries is recalling 1,360 DEXMED ACCESS CENTER TRAY kits with Prevantics antiseptic swabs due to uncertain validation of manufacturing test methods. The affected kits were distributed in Florida, New Jersey, and Tennessee.

    Product
    DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1832-2021·2021-06-16

    DeRoyal Pacemaker Tray Mislabeled With Wrong Anesthetic Concentration

    DeRoyal is recalling surgical procedure packs due to mislabeling. The product contains 0.5% Bupivacaine but is labeled as 1% Lidocaine, creating a medication identification error.

    Product
    DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1834-2021·2021-06-16

    Surgical procedure pack anesthetic mislabeled with wrong drug and strength

    DeRoyal Angio Cath Removal Tray contains mislabeled anesthetic; the label indicates 1% Lidocaine but the tray actually contains 0.5% Bupivacaine. This FDA Class I recall affects 60 trays distributed in MS, VA, LA, and NY.

    Product
    DeRoyal Angio Cath Removal Tray, REF 89-9936.02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1833-2021·2021-06-16

    DeRoyal Heart Cath Procedure Packs Recalled for Anesthetic Mislabeling

    DeRoyal Industries is recalling 66 heart catheterization procedure packs due to mislabeling of anesthetic contents. The packs contain 0.5% Bupivacaine but are labeled as containing 1% Lidocaine, creating a medication error risk during surgery.

    Product
    DeRoyal Heart Cath Procedure Pack, REF 89-6556.08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1138-2021·2021-03-03

    DeRoyal Recalls Non-Sterile Sternum Saw Blades in Surgical Packs

    DeRoyal Industries is recalling 309 CV Basin Set Packs because the included sternum saw blades are not sterile.

    Product
    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.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1139-2021·2021-03-03

    DeRoyal Open Heart Packs Recalled Due to Non-Sterile Sternum Saw Blades

    DeRoyal Industries is recalling 1,084 Open Heart Packs because the included sternum saw blades were not sterile, despite being part of a surgical procedure pack.

    Product
    Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs including sternum saw blades.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1140-2021·2021-03-03

    DeRoyal Heart Pack Recall Due to Non-Sterile Sternum Saw Blades

    DeRoyal Industries is recalling Heart Packs containing non-sterile sternum saw blades. The affected surgical saw blades are marked with a green non-sterile sticker.

    Product
    Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure packs including sternum saw blades.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1963-2020·2020-05-20

    DeRoyal Sterile Custom Kits Recalled Due to Packaging Holes

    DeRoyal Industries is recalling sterile custom kits packaged with BD PosiFlush syringes because holes in the packaging may compromise sterility.

    Product
    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. P
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1604-2020·2020-04-08

    DeRoyal Security Cuffs Recalled for Insufficient Buckle Hold Force

    DeRoyal is recalling 94 pairs of security cuffs because the buckles do not meet required mechanical hold force standards.

    Product
    DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0706-2020·2019-12-25

    DeRoyal Warrior Recovery Knee Brace Recalled for Hinge Breakage Risk

    DeRoyal Industries is recalling Warrior Recovery Knee Braces because the hinge may break, causing the brace to come apart.

    Product
    DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2293-2019·2019-08-28

    DeRoyal Enteral Safe Feeding Tubes Recalled for Connector Detachment

    DeRoyal Industries is recalling specific polyurethane feeding tubes because the connector may detach from the tube.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1981-2019·2019-07-24

    DeRoyal Custom Surgical Packs Recalled for Sterility Barrier Defect

    DeRoyal is recalling 108 custom surgical packs in Oklahoma because they contain defective Cardinal Health Blunt Cannulas that could compromise sterility.

    Product
    DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0746-2019·2019-01-23

    DeRoyal Enteral Safe Feed Tube Recall Due to Incorrect Sizing

    DeRoyal Industries is recalling 200 Enteral Safe Feed Tubes labeled as 6.5 FR but containing 5 FR tubes. The recall covers units distributed to Texas and Utah.

    Product
    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
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1583-2018·2018-05-09

    DeRoyal SURGI MATE Electrosurgical Pencils Recalled for Sterility Labeling Error

    DeRoyal Industries is recalling 1,800 non-sterile electrosurgical pencils that were incorrectly labeled as sterile. The affected units were distributed to Honduras, Belgium, and The Netherlands.

    Product
    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
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0637-2018·2018-02-28

    DeRoyal recalls custom sterile surgical packs with Terumo valve defect

    DeRoyal Industries Inc is recalling 181 custom sterile surgical packs distributed in New York due to a Terumo valve defect causing no flow.

    Product
    Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0334-2018·2018-01-24

    DeRoyal Recalls Sterile Surgical Kits Due to Expired Prep Pads

    DeRoyal is recalling 226 sterile surgical kits because the included povidone iodine prep pads do not support the 36-month expiration date listed on the label.

    Product
    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 89-86
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0199-2018·2017-12-13

    DeRoyal Surgical Kits Recalled for Incorrect Expiration Date on Prep Pads

    DeRoyal is recalling sterile custom surgical kits containing Medline Aplicare Povidone Iodine Prep Pads due to incorrect expiration dates.

    Product
    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) Incis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2639-2017·2017-07-05

    DeRoyal Dolphin Inflation Device Recalled for Sterility Assurance Defect

    DeRoyal Industries is recalling 426 Dolphin Inflation Devices due to a primary packaging defect that may compromise sterility.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1247-2017·2017-03-01

    DeRoyal Heart Tracecart Recall Due to Contained Chest Drainage Product Issue

    DeRoyal Industries is recalling Heart Tracecarts because they contain a Maquet Getinge chest drainage product affected by a separate packaging recall.

    Product
    DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1248-2017·2017-03-01

    DeRoyal Heart Tracecart Recall Due to Sterile Component Packaging Issue

    DeRoyal is recalling Heart Tracecarts because they contain a sterile chest drainage product affected by a packaging configuration issue.

    Product
    SRHS DeRoyal Heart Tracecart REF 53-1913, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.
    Category
    Medical Device
    Distribution
    2 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

DeRoyal

American healthcare company

Founded
1973

Official website

Source: Wikidata (Q5244070), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.