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.

201–225 of 226

  • ModerateFDA (Devices)·Z-0712-2017·2016-12-14

    DeRoyal Recalls PneuGel Tennis Elbow Supports Due to Mold Complaints

    DeRoyal Industries is recalling 56 units of PneuGel tennis elbow supports because of complaints regarding mold on the straps.

    Product
    TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0713-2017·2016-12-14

    DeRoyal Recalls Pneugel Tennis Elbow Straps Due to Mold Complaints

    DeRoyal Industries is recalling 791 units of Pneugel Tennis Elbow Straps because of complaints regarding mold on the product.

    Product
    PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2678-2016·2016-09-07

    DeRoyal Recalls Custom Surgical Kits Due to Sterility Concerns

    DeRoyal Industries is recalling 26 custom surgical kits containing Bard Toomey Irrigation Syringes due to a possible package defect that may affect sterility.

    Product
    Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2679-2016·2016-09-07

    DeRoyal recalls two custom surgical kits with potential sterility defect

    DeRoyal Industries Inc is recalling two custom surgical kits containing a BARD Toomey Irrigation Syringe due to a possible package slit that may affect sterility.

    Product
    DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O,
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0345-2016·2015-12-09

    DeRoyal Recalls Neonatal Temperature Skin Sensors Due to Soldering Defect

    DeRoyal Industries is recalling four lots of Hydro-Temp Neonatal Temperature Skin Sensors because incorrect soldering prevents temperature readings on infant warming systems.

    Product
    HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0363-2016·2015-12-09

    DeRoyal and GEO-MED sterile surgical kits recalled for seal defects

    DeRoyal Industries is recalling 836 sterile custom surgical kits because a component may have packaging seal defects that compromise sterility.

    Product
    DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7859.01 2) Emergency CABG Pack Pgybk, ref 89-7859.02 3) Open Heart Pack A&B Pgybk, ref 89-7750.02 4) Open Heart Pack A&B Pgybk, ref 89-7750.03 5) Intl-Cardiac Surgery Pack A&B Pgybk, ref 89-8514.02
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0241-2016·2015-11-18

    DeRoyal Surgical Kits Recalled Due to Sterilant Exposure

    DeRoyal Industries is recalling specific lots of sterile surgical kits containing 3M DuraPrep solution due to unintended exposure to sterilant during the sterilization process.

    Product
    DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE or 2016-09EF, or 2016-09EG, or Catalog No. 863, Lot No. 2016-08DC: TOTAL JOINT PACK A&B, REF 89-5720.04; PACEMAKER PACK, REF 89-6717.03
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0240-2016·2015-11-18

    DeRoyal Recalls Sterile Surgical Kits Due to Sterilant Exposure

    DeRoyal Industries is recalling 355 sterile surgical kits containing 3M DuraPrep solution due to unintended exposure to sterilant during package sterilization.

    Product
    DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: TOTAL KNEE A & B, REF 89-4561.11; TOTAL HIP A & B, REF 89-4562.12; PODIATRY TRAY, REF 89-3101.04; KNEE SCOPE PACK, REF 89-7744.03; KNEE PACK, REF 89-819
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1837-2015·2015-07-01

    DeRoyal Recalls Custom Surgical Kits with Defective Medtronic Gloves

    DeRoyal Industries is recalling custom surgical kits containing Medtronic Devon Light Gloves due to splits or holes.

    Product
    Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ANGIO TRAY, REF 50-12127; NEURO SPINE TRAY, LAP CHOLE TRACECART(R), REF 53-1931; MINOR PROCEDURE TRACECART (R), REF 53-1932; MAJOR PROCEDURE TRACECART (R), 53-1933; Cover Light Handle Flexible, REF 5-347
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1642-2015·2015-05-27

    DeRoyal Specimen Retrieval Bags Recalled for Tearing During Use

    DeRoyal Industries is recalling 5,359 Medium Specimen Retrieval Bags because they may tear or come apart during laparoscopic procedures.

    Product
    DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag indicated for use in laparoscopic procedures to capture and remove organs or tissue from the body cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0098-2015·2014-10-29

    DeRoyal SafeLiner Suction Canister Kit Recalled for Insufficient Seal

    DeRoyal Industries is recalling 5,112 units of SafeLiner Suction Canister Kits due to an insufficient seal under low or intermittent suction conditions.

    Product
    DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, general hospital
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0097-2015·2014-10-29

    DeRoyal and Novaplus Suction Canisters Recalled for Insufficient Seal

    DeRoyal Industries is recalling 13,900 non-sterile suction canisters and lids because they may have an insufficient seal under low or intermittent suction conditions.

    Product
    Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. 2) NOVAPLUS(TM) SUCTION CANISTER, 1000 cc, SEMI-RIGID, Cat. No. V71-6510, NON-STERILE, Rx Only general hospital
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2125-2014·2014-08-06

    DeRoyal Cardiac Hypothermia Tray Recalled Due to Contaminated Irrigation Sets

    DeRoyal is recalling Cardiac Hypothermia Trays because they contained irrigation sets previously recalled by Hospira.

    Product
    DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2124-2014·2014-08-06

    DeRoyal Knee Arthroscopy Pack Recalled Due to Component Recall

    DeRoyal Industries is recalling 128 Knee Arthroscopy Packs because they contain Irrigation Sets previously recalled by Hospira.

    Product
    DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Manufacturer: DeRoyal Industries, Inc.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1210-2014·2014-03-26

    DeRoyal Cotton Adjustable Limb Holders Recalled for Moldy Smell

    DeRoyal Industries is recalling 8,962 pairs of cotton adjustable limb holders due to a moldy smell. The products were distributed in the US and Argentina.

    Product
    DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product Usage: Limb holders are intended for mildly to moderate agitated or disoriented patients who disrupt medical treatment and/or cause harm to themselves and/or others
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1134-2014·2014-03-12

    DeRoyal Circumcision Clamps Recalled for Manufacturing Defects

    DeRoyal Industries is recalling three lots of circumcision clamps that may not clamp completely at the surgical site due to manufacturing errors.

    Product
    DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.
    Category
    Medical Device
    Distribution
    10 states
  • SevereFDA (Devices)·Z-0837-2014·2014-02-05

    DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature and Shock Risks

    DeRoyal Industries is recalling 48 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature and have caused electric shocks.

    Product
    DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps NS, REF T654NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0836-2014·2014-02-05

    DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure

    DeRoyal Industries is recalling 409 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.

    Product
    DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0839-2014·2014-02-05

    DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure

    DeRoyal Industries is recalling 25 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.

    Product
    DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Foot/Ankle Blanket NS, REF T656NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0834-2014·2014-02-05

    DeRoyal Aquarius Temperature Therapy Units Recalled for Temperature Control Failure

    DeRoyal Industries is recalling 738 Aquarius Temperature Therapy units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.

    Product
    Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China. Physical Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0835-2014·2014-02-05

    DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure

    DeRoyal Industries is recalling 121 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.

    Product
    DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF T652NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0838-2014·2014-02-05

    DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure

    DeRoyal Industries is recalling 2 units of the Aquarius Hot/Cold Therapy Combo Unit due to temperature monitoring failures and electric shock reports.

    Product
    DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS, REF T655NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0275-2014·2013-11-20

    DeRoyal Surgical Eye Spears Recalled for Incorrect X-Ray Detectability Labeling

    DeRoyal Industries is recalling one lot of Surgical Eye Spears because they were labeled as x-ray detectable but contained non-detectable product.

    Product
    DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE IN GUATEMALA cleaning of fluids from surgical site in or near the eye
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2113-2013·2013-09-04

    DeRoyal Recalls Insufflation Tubing Sets Due to Materials Incompatibility

    DeRoyal Industries is recalling specific lots of insufflation tubing sets because materials incompatibility could cause occlusion, potentially preventing gas flow during laparoscopic surgery.

    Product
    DeRoyal Insufflation Tubing sets: 1) REF 28-0206 Insufflation Tubing, Laparoscopic Rx Only 2) REF 28-0214 Hi-Flow Insufflation Tubing Rx Only 3) REF 28-0216 Tubing, Insuf w/.3 Micr Filter Rx Only 4) REF 28-0217 Insufflation Tubing, Laparoscopic Rx Only 5) REF 28-0208 Insu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1692-2013·2013-07-17

    DeRoyal Recalls Ortho Total Joint Tracecart Kits Due to Sterilization Concerns

    DeRoyal Industries is recalling 87 units of GEO-MED ORTHO TOTAL JOINT TRACECART kits because they contained Stryker togas with a potential sterilization problem.

    Product
    GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical
    Category
    Medical Device
    Distribution
    Distributed nationwide

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.