Browse Device Recalls

225 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 225 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 225 FDA device recalls.

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DateProductReasonClassFirm
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 the suction canister... Class II DeRoyal Industries Inc
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 tubing / yankauer con... Class II DeRoyal Industries Inc
Oct 3, 2024 DeRoyal C-SECTION TRACEPACK, REF 89-9338-06 DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker Safe... Class II DeRoyal Industries Inc
Oct 3, 2024 DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06 DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker Safe... Class II DeRoyal Industries Inc
Oct 3, 2024 DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06 DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker Safe... Class II DeRoyal Industries Inc
Oct 3, 2024 DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06 DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker Safe... Class II DeRoyal Industries Inc
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 Assist 16FR Silver ... Class I DeRoyal Industries Inc
Nov 22, 2023 DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572 Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure tran... Class II DeRoyal Industries Inc
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 contain the B.Braun Me... Class II DeRoyal Industries Inc
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 sterility of the procedure... Class II DeRoyal Industries Inc
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 sterility of the procedure... Class II DeRoyal Industries Inc
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 sterility of the procedure... Class II DeRoyal Industries Inc
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 sterility of the procedure... Class II DeRoyal Industries Inc
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 sterility of the procedure... Class II DeRoyal Industries Inc
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 recalled by another firm. Class II DeRoyal Industries Inc
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 recalled by another firm. Class II DeRoyal Industries Inc
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. This shrinkage cause... Class II DeRoyal Industries Inc
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 contain a Medtronic No... Class II DeRoyal Industries Inc
Nov 28, 2022 DeRoyal Tonsillectomy Tray, REF 89-10698.01 DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot ... Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal CRANI PACK, REF 89-10242.04 DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal NEURO PACK, REF 89-10171.06 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 GEO-MED PODIATRY PACK PGYBK, REF 89-6240.05 DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal LAPINECTOMY PACK, REF 89-7198.10 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal CATARACT PACK, REF 89-10086.05 DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal EYE PACK, REF 89-4051.09 DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal BASIC NEURO PACK, REF 89-7258.13 DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal BIOPSY PACK, REF 89-9270.05 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal CUSTOM NEURO PACK, REF 89-8392.09 DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal ENDOVENOUS PACK, REF 89-7762.05 DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal SHOULDER PACK, REF 89-6830.13 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal HEART PACK, REF 89-8351.11 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal TOTAL HIP KIT, REF 89-9498.08 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal SPINAL FUSION PACK, REF 89-7515.14 DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal NEURO PACK, REF 89-10682.02 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal NEURO PACK, REF 89-9253.09 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal BASIC EYE PACK, REF 89-8337.09 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal TOTAL SHOULDER PACK, REF 89-10151.05 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal BASIC PACK, REF 89-8633.07 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal EMERGENT TRAUMA PACK, ref 89-9453.12 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.08 DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal GU PACK, REF 89-10665.02 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal SHOULDER KIT, REF 89-9497.10 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal BASIC EYE PACK, REF 89-8337.08 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal BASIC NEURO PACK, REF 89-7258.12 DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal BREAST TRAY, REF 89-7033.07 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 GEO-MED PODIATRY PACK PGYBK, REF 89-8700.01 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal GU ROBOTIC PACK, REF 89-7063.12 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal PACEMAKER ICD PACK, REF 89-10216.03 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal SPINE PACK, REF 89-8361.10 DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal CUSTOM NEURO PACK, REF 89-8392.10 XXX Class II DeRoyal Industries Inc

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.