DeRoyal Industries Inc

Complete recall history across all FDA and CPSC categories — 225 total recalls

DeRoyal Industries Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (225)

FDA medical device enforcement actions by DeRoyal Industries Inc. Showing most recent 50.

Date Product Reason Class
Jan 31, 2025 DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tu... Due to the inner diameter of the suction tubing connector being smaller than ... Class II
Jan 15, 2025 DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C... The tubing may not ensure that the yankauer stays intact, and secure to the t... Class II
Oct 3, 2024 DeRoyal C-SECTION TRACEPACK, REF 89-9338-06 DeRoyal is recalling certain lots of surgical procedure pack products that co... Class II
Oct 3, 2024 DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06 DeRoyal is recalling certain lots of surgical procedure pack products that co... Class II
Oct 3, 2024 DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06 DeRoyal is recalling certain lots of surgical procedure pack products that co... Class II
Oct 3, 2024 DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06 DeRoyal is recalling certain lots of surgical procedure pack products that co... Class II
Feb 13, 2024 GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECAR... DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse... Class I
Nov 22, 2023 DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572 Kit were manufactured and distributed with Edwards Life Sciences TruWave Disp... Class II
Sep 18, 2023 DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit DeRoyal is recalling certain lots of surgical procedure pack products that co... Class II
May 30, 2023 Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION W... The outer package seal could be open, or compromised which affects the steril... Class II
May 30, 2023 Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219 The outer package seal could be open, or compromised which affects the steril... Class II
May 30, 2023 Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDAR... The outer package seal could be open, or compromised which affects the steril... Class II
May 30, 2023 Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF... The outer package seal could be open, or compromised which affects the steril... Class II
May 30, 2023 Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK,... The outer package seal could be open, or compromised which affects the steril... Class II
Apr 17, 2023 Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK,... The custom procedure packs contain light handle covers that have been recalle... Class II
Apr 17, 2023 Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTIO... The custom procedure packs contain light handle covers that have been recalle... Class II
Feb 9, 2023 DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B The reason for the voluntary recall is due to shrinkage of the canister lid. ... Class II
Dec 12, 2022 DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10 DeRoyal is recalling certain lots of surgical procedure pack products that co... Class II
Nov 28, 2022 DeRoyal Tonsillectomy Tray, REF 89-10698.01 DeRoyal is recalling certain lots of surgical procedure pack products that co... Class II
Nov 3, 2022 DeRoyal CRANI PACK, REF 89-10242.04 DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes... Class II
Nov 3, 2022 DeRoyal NEURO PACK, REF 89-10171.06 XXX Class II
Nov 3, 2022 GEO-MED PODIATRY PACK PGYBK, REF 89-6240.05 DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes... Class II
Nov 3, 2022 DeRoyal LAPINECTOMY PACK, REF 89-7198.10 XXX Class II
Nov 3, 2022 DeRoyal CATARACT PACK, REF 89-10086.05 DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes... Class II
Nov 3, 2022 DeRoyal EYE PACK, REF 89-4051.09 DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes... Class II
Nov 3, 2022 DeRoyal BASIC NEURO PACK, REF 89-7258.13 DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes... Class II
Nov 3, 2022 DeRoyal BIOPSY PACK, REF 89-9270.05 XXX Class II
Nov 3, 2022 DeRoyal CUSTOM NEURO PACK, REF 89-8392.09 DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes... Class II
Nov 3, 2022 DeRoyal ENDOVENOUS PACK, REF 89-7762.05 DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes... Class II
Nov 3, 2022 DeRoyal SHOULDER PACK, REF 89-6830.13 XXX Class II
Nov 3, 2022 DeRoyal HEART PACK, REF 89-8351.11 XXX Class II
Nov 3, 2022 DeRoyal TOTAL HIP KIT, REF 89-9498.08 XXX Class II
Nov 3, 2022 DeRoyal SPINAL FUSION PACK, REF 89-7515.14 DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes... Class II
Nov 3, 2022 DeRoyal NEURO PACK, REF 89-10682.02 XXX Class II
Nov 3, 2022 DeRoyal NEURO PACK, REF 89-9253.09 XXX Class II
Nov 3, 2022 DeRoyal BASIC EYE PACK, REF 89-8337.09 XXX Class II
Nov 3, 2022 DeRoyal TOTAL SHOULDER PACK, REF 89-10151.05 XXX Class II
Nov 3, 2022 DeRoyal BASIC PACK, REF 89-8633.07 XXX Class II
Nov 3, 2022 DeRoyal EMERGENT TRAUMA PACK, ref 89-9453.12 XXX Class II
Nov 3, 2022 GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.08 DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes... Class II
Nov 3, 2022 DeRoyal GU PACK, REF 89-10665.02 XXX Class II
Nov 3, 2022 DeRoyal SHOULDER KIT, REF 89-9497.10 XXX Class II
Nov 3, 2022 DeRoyal BASIC EYE PACK, REF 89-8337.08 XXX Class II
Nov 3, 2022 DeRoyal BASIC NEURO PACK, REF 89-7258.12 DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes... Class II
Nov 3, 2022 DeRoyal BREAST TRAY, REF 89-7033.07 XXX Class II
Nov 3, 2022 GEO-MED PODIATRY PACK PGYBK, REF 89-8700.01 XXX Class II
Nov 3, 2022 DeRoyal GU ROBOTIC PACK, REF 89-7063.12 XXX Class II
Nov 3, 2022 DeRoyal PACEMAKER ICD PACK, REF 89-10216.03 XXX Class II
Nov 3, 2022 DeRoyal SPINE PACK, REF 89-8361.10 DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes... Class II
Nov 3, 2022 DeRoyal CUSTOM NEURO PACK, REF 89-8392.10 XXX Class II

View all 225 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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