PlainRecalls

DeRoyal Industries Inc

153 recalls on record · Latest: Feb 26, 2025

DeRoyal Industries Inc Recall Insight

DeRoyal Industries Inc appears on 153 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.182% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Feb 26, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 2 critical, 47 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Feb 5, 2014 to Dec 21, 2022.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Dec 21, 2022

DeRoyal BREAST AUGMENTATION PACK, REF 89-9618.05

FDA Devices Moderate Dec 21, 2022

DeRoyal PODIATRY PACK, REF 89-8359.13

FDA Devices Moderate Dec 21, 2022

DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.09

FDA Devices Moderate Dec 21, 2022

DeRoyal FOOT PACK, REF 89-9252.07

FDA Devices Moderate Dec 21, 2022

DeRoyal NEURO SPINE BACK PACK PGYBK, REF 89-10853.01

FDA Devices Moderate Dec 21, 2022

DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.10

FDA Devices Moderate Dec 21, 2022

DeRoyal NEURO PACK, REF 89-9253.07

FDA Devices Moderate Dec 21, 2022

DeRoyal HAND PACK, REF 89-10314.03

FDA Devices Moderate Dec 21, 2022

DeRoyal PAIN TRAY, REF 89-10464.02

FDA Devices Moderate Dec 21, 2022

DeRoyal PICC LINE TRAY PGYBK, REF 89-6150.13

FDA Devices Moderate Dec 21, 2022

GEO-MED TOTAL KNEE PACK A & B, REF 89-6799.02

FDA Devices Moderate Dec 21, 2022

DeRoyal CARDIAC LINEN PACK, REF 89-10543.02

FDA Devices Moderate Dec 21, 2022

DeRoyal SHOULDER PACK, REF 89-9449.12

FDA Devices Moderate Dec 21, 2022

DeRoyal CANNULTED HIP PACK CSM, REF 89-6977.09

FDA Devices Moderate Dec 21, 2022

DeRoyal BIOPSY PACK, REF 89-9270.04

FDA Devices Moderate Dec 21, 2022

DeRoyal FOOT PACK, REF 89-9252.06

FDA Devices Moderate Dec 21, 2022

DeRoyal SHOULDER ARTHORSCOPY PACK RF, REF 89-6628.09

FDA Devices Moderate Dec 21, 2022

DeRoyal LAMINECTOMY PACK, REF 89-10209.02

FDA Devices Moderate Sep 7, 2022

DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors

FDA Devices Moderate Aug 31, 2022

DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle, Fixed, Quick Release, REF …

FDA Devices Moderate Apr 13, 2022

DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin …

FDA Devices Moderate Apr 13, 2022

DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of th…

FDA Devices Critical Jun 16, 2021

DeRoyal Angio Cath Removal Tray, REF 89-9936.02

FDA Devices Critical Jun 16, 2021

DeRoyal Heart Cath Procedure Pack, REF 89-6556.08

FDA Devices Moderate Mar 3, 2021

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 sa…

FDA Devices Moderate Mar 3, 2021

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 proce…

FDA Devices Moderate Mar 3, 2021

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 blade…

FDA Devices Moderate May 20, 2020

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, 89-62…

FDA Devices Moderate Dec 25, 2019

DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP

FDA Devices Moderate Jul 24, 2019

DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack

FDA Devices Moderate Jan 24, 2018

DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, …

FDA Devices Moderate Dec 13, 2017

DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and Drainage Tray, REF 47-763.04 b) Incision and Dra…

FDA Devices Moderate Jul 5, 2017

DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedures to in…

FDA Devices Low Mar 1, 2017

DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.

FDA Devices Moderate Dec 14, 2016

TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis

FDA Devices Moderate Dec 14, 2016

PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis

FDA Devices Moderate Sep 7, 2016

Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit.

FDA Devices Moderate Sep 7, 2016

DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O,

FDA Devices Moderate Dec 9, 2015

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…

FDA Devices Moderate Nov 18, 2015

DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE or 2016-09EF,…

FDA Devices Moderate Nov 18, 2015

DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: TOTAL KNEE A & B, REF 8…

FDA Devices Moderate May 27, 2015

DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag indicated f…

FDA Devices Moderate Oct 29, 2014

Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. 2) NOVAPLUS(TM) SUCTION…

FDA Devices Moderate Oct 29, 2014

DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, general hospital

FDA Devices Moderate Aug 6, 2014

DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Manufacturer: DeRoyal Industries, Inc.

FDA Devices Moderate Mar 26, 2014

DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product Usage: Limb holders are intended for mildly to moderate agitated or di…

FDA Devices Moderate Mar 12, 2014

DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.

FDA Devices Moderate Feb 5, 2014

Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China. …

FDA Devices Moderate Feb 5, 2014

DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk L…

FDA Devices Moderate Feb 5, 2014

DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps NS, REF T654NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBus…

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds