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 |
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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