PlainRecalls

DeRoyal Industries Inc

Compiled from official public sources by the editorial team.

225 recalls on record · Latest: Mar 12, 2025

DeRoyal Industries Inc Recall Insight

DeRoyal Industries Inc appears on 225 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.221% 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 Mar 12, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 3 critical, 45 moderate, and 2 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 Dec 14, 2016 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 BASIC NEURO PACK, REF 89-7258.12

FDA Devices Moderate Dec 21, 2022

DeRoyal BASIC EYE PACK, REF 89-8337.08

FDA Devices Moderate Dec 21, 2022

DeRoyal SHOULDER KIT, REF 89-9497.10

FDA Devices Moderate Dec 21, 2022

DeRoyal GU PACK, REF 89-10665.02

FDA Devices Moderate Dec 21, 2022

GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.08

FDA Devices Moderate Dec 21, 2022

DeRoyal EMERGENT TRAUMA PACK, ref 89-9453.12

FDA Devices Moderate Dec 21, 2022

DeRoyal BASIC PACK, REF 89-8633.07

FDA Devices Moderate Dec 21, 2022

DeRoyal TOTAL SHOULDER PACK, REF 89-10151.05

FDA Devices Moderate Dec 21, 2022

DeRoyal BASIC EYE PACK, REF 89-8337.09

FDA Devices Moderate Dec 21, 2022

DeRoyal NEURO PACK, REF 89-9253.09

FDA Devices Moderate Dec 21, 2022

DeRoyal NEURO PACK, REF 89-10682.02

FDA Devices Moderate Dec 21, 2022

DeRoyal SPINAL FUSION PACK, REF 89-7515.14

FDA Devices Moderate Dec 21, 2022

DeRoyal TOTAL HIP KIT, REF 89-9498.08

FDA Devices Moderate Dec 21, 2022

DeRoyal HEART PACK, REF 89-8351.11

FDA Devices Moderate Dec 21, 2022

DeRoyal SHOULDER PACK, REF 89-6830.13

FDA Devices Moderate Dec 21, 2022

DeRoyal ENDOVENOUS PACK, REF 89-7762.05

FDA Devices Moderate Dec 21, 2022

DeRoyal CUSTOM NEURO PACK, REF 89-8392.09

FDA Devices Moderate Dec 21, 2022

DeRoyal BIOPSY PACK, REF 89-9270.05

FDA Devices Moderate Dec 21, 2022

DeRoyal BASIC NEURO PACK, REF 89-7258.13

FDA Devices Moderate Dec 21, 2022

DeRoyal EYE PACK, REF 89-4051.09

FDA Devices Moderate Dec 21, 2022

DeRoyal CATARACT PACK, REF 89-10086.05

FDA Devices Moderate Dec 21, 2022

DeRoyal LAPINECTOMY PACK, REF 89-7198.10

FDA Devices Moderate Dec 21, 2022

GEO-MED PODIATRY PACK PGYBK, REF 89-6240.05

FDA Devices Moderate Dec 21, 2022

DeRoyal NEURO PACK, REF 89-10171.06

FDA Devices Moderate Dec 21, 2022

DeRoyal CRANI PACK, REF 89-10242.04

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 Moderate Apr 13, 2022

DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the pati…

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 Critical Jun 16, 2021

DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06

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 Apr 8, 2020

DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.

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 Aug 28, 2019

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…

FDA Devices Moderate Jul 24, 2019

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

FDA Devices Moderate Jan 23, 2019

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…

FDA Devices Moderate May 9, 2018

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

FDA Devices Moderate Feb 28, 2018

Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy

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 Low Mar 1, 2017

SRHS DeRoyal Heart Tracecart REF 53-1913, 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

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Data Sources

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

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.