Browse Device Recalls
740 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 740 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 740 FDA device recalls in TN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 6, 2023 | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... | There is the potential for out of specification device geometries. widths, lengths, heights, and... | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 6, 2023 | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... | There is the potential for out of specification device geometries. widths, lengths, heights, and... | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 6, 2023 | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... | There is the potential for out of specification device geometries. widths, lengths, heights, and... | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 6, 2023 | Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Stand... | There is the potential for out of specification device geometries. widths, lengths, heights, and... | Class II | Medtronic Sofamor Danek USA 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 |
| May 10, 2023 | PushTracker E3 component utilized with the SmartDrive MX2+ Power Assist Devic... | When multiple processes are running on the watch's Central Processing Unit (CPU), the application... | Class II | Permobil |
| May 10, 2023 | PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Devic... | When multiple processes are running on the watch's Central Processing Unit (CPU), the application... | Class II | Permobil |
| May 2, 2023 | Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Par... | Recent complaint data indicates that the revision rate may be trending higher than corresponding ... | Class II | Smith & Nephew, Inc. |
| May 2, 2023 | Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part ... | Recent complaint data indicates that the revision rate may be trending higher than corresponding ... | Class II | Smith & Nephew, Inc. |
| May 2, 2023 | Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components... | Recent complaint data indicates that the revision rate may be trending higher than corresponding ... | Class II | Smith & Nephew, Inc. |
| May 2, 2023 | Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part ... | Recent complaint data indicates that the revision rate may be trending higher than corresponding ... | Class II | Smith & Nephew, 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 |
| Apr 10, 2023 | stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization... | Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked o... | Class II | Wright Medical Technology, Inc. |
| Apr 10, 2023 | stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization... | Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked o... | Class II | Wright Medical Technology, Inc. |
| Mar 27, 2023 | JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM | A mispack occurred during the manufacturing process, resulting in the box incorrectly containing ... | Class II | Smith & Nephew, Inc. |
| Mar 8, 2023 | MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device | There is a potential for breakage of the small screw used to affix the anti-backout plate. | Class II | Medacta Usa Inc |
| Mar 8, 2023 | MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device | There is a potential for breakage of the small screw used to affix the anti-backout plate. | Class II | Medacta Usa Inc |
| Mar 8, 2023 | MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device | There is a potential for breakage of the small screw used to affix the anti-backout plate. | Class II | Medacta Usa Inc |
| Mar 8, 2023 | MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion de... | There is a potential for breakage of the small screw used to affix the anti-backout plate. | Class II | Medacta Usa Inc |
| Mar 8, 2023 | MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device | There is a potential for breakage of the small screw used to affix the anti-backout plate. | Class II | Medacta Usa Inc |
| Mar 8, 2023 | MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device | There is a potential for breakage of the small screw used to affix the anti-backout plate. | Class II | Medacta Usa Inc |
| Feb 16, 2023 | INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXI... | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 ba... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 16, 2023 | INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.... | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 ba... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 16, 2023 | INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.... | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 ba... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 16, 2023 | INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.... | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 ba... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 16, 2023 | INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.... | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 ba... | Class II | Medtronic Sofamor Danek USA 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 |
| Feb 8, 2023 | Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S420... | 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 Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3C... | 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: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) ... | 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 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 |
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.