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DeRoyal Industries Recalls
226 recalls on record · July 25, 2012 to June 10, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 29, 2014Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, general hospital
Hazard: These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition.
October 29, 2014Medical DevicesFDA
DeRoyal Industries Inc recalls Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx O
Hazard: These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition.
August 6, 2014Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatem
Hazard: The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.
August 6, 2014Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Manufacturer: De
Hazard: The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.
March 26, 2014Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product Usage: Limb holders are intended for mild
Hazard: Moldy smell in product
March 12, 2014Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Indust
Hazard: Three lots of circumcision clamps were manufactured out of specification and as a result may not properly clamp at the surgical site completely.
February 5, 2014Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Foot/Ankle Blanket NS, REF T656NS, Rx only, Manufacturer DeRoyal I
Hazard: The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.
February 5, 2014Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS, REF T655NS, Rx only, Manufacturer D
Hazard: The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.
February 5, 2014Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps NS, REF T654NS, Rx only, Manufacturer DeRoy
Hazard: The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.
February 5, 2014Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS, Rx only, Manufacturer DeRoyal
Hazard: The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.
February 5, 2014Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF T652NS, Rx only, Manufacturer DeRoya
Hazard: The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.
February 5, 2014Medical DevicesFDA
DeRoyal Industries Inc recalls Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell,
Hazard: The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.
November 20, 2013Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell
Hazard: One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product.
September 4, 2013Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal Insufflation Tubing sets: 1) REF 28-0206 Insufflation Tubing, Laparoscopic Rx Only 2) REF 28-0214 Hi-Flow Insu
Hazard: DeRoyal Industries is recalling their product Insufflation Tubing Sets due to materials incompatibility which could possibly result in occlusion at or near the filter housing which could prevent the flow of gas through the device.
July 17, 2013Medical DevicesFDA
DeRoyal Industries Inc recalls GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical
Hazard: DeRoyal recalled kits that contained Stryker togas which were recalled for a potential problem with sterilization.
July 25, 2012Medical DevicesFDA
DeRoyal Industries Inc recalls Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03
Hazard: Surgical kits and trays contain Stryker Hytrel Togas which were recalled because the clear tape, that is intended to aid in the prevention of patient's fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process.