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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.