Browse Device Recalls
755 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 755 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 755 FDA device recalls in TN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 8, 2023 | Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; ... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STR... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; ... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, R... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM ... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; ... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106;... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b)... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 2, 2023 | ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation de... | Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates wit... | Class II | Wright Medical Technology, Inc. |
| Feb 2, 2023 | ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation de... | Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates wit... | Class II | Wright Medical Technology, 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 |
| Nov 3, 2022 | DeRoyal CATARACT PACK, REF 89-7135.10 | 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 SHOULDER ARTHOSCOPY PACK, REF 89-10061.02 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal TOTAL HIP PACK, REF 89-9301.07 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal TOTAL HIP KIT, REF 89-9498.10 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal ABDOMINOPLASTY W/LIPO PACK, REF 89-9557.03 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal NEURO PACK, REF 89-10171.05 | 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.