Device recalls
Recall records from FDA, newest initiation date first.
Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.
Data as of , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-0075-2022 | Class II | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31... | Datascope Corp. | DSP | |
| Z-0104-2022 | Class II | Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068 | K2M, Inc | OVE | |
| Z-0077-2022 | Class II | Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59... | W. L. Gore & Associates, Inc. | PRL | |
| Z-0031-2022 | Class II | Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological... | Nox Medical | MNR | |
| Z-0010-2022 | Class I | Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF... | DJO, LLC | ITX | |
| Z-0009-2022 | Class I | GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266... | DJO, LLC | ITX | |
| Z-0034-2022 | Class II | Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201 | FLOWER ORTHOPEDICS Corporation dba Conventus Flower | HRS | |
| Z-0083-2022 | Class II | cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number... | Roche Molecular Systems Inc | OWD | |
| Z-0011-2022 | Class II | ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and... | Mortara Instrument, Inc. | DPS | |
| Z-0172-2022 | Class II | REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter... | W. L. Gore & Associates, Inc. | MLV | |
| Z-0171-2022 | Class II | REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter... | W. L. Gore & Associates, Inc. | MLV | |
| Z-0170-2022 | Class II | REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter... | W. L. Gore & Associates, Inc. | MLV | |
| Z-0169-2022 | Class II | REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter... | W. L. Gore & Associates, Inc. | MLV | |
| Z-0168-2022 | Class II | REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter... | W. L. Gore & Associates, Inc. | MLV | |
| Z-0167-2022 | Class II | REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter... | W. L. Gore & Associates, Inc. | MLV | |
| Z-0166-2022 | Class II | REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter... | W. L. Gore & Associates, Inc. | MLV | |
| Z-0165-2022 | Class II | REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter... | W. L. Gore & Associates, Inc. | MLV | |
| Z-0086-2022 | Class II | Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6... | Medtronic Sofamor Danek USA Inc | OVE | |
| Z-0085-2022 | Class II | Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12... | Medtronic Sofamor Danek USA Inc | OVD | |
| Z-0164-2022 | Class II | REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter... | W. L. Gore & Associates, Inc. | MLV | |
| Z-2499-2021 | Class I | DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set | Deroyal Industries, Inc. Lafollette | LRO | |
| Z-0084-2022 | Class II | MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System | bioMerieux, Inc. | OUG | |
| Z-0008-2022 | Class I | Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application... | Abbott Molecular, Inc. | QJR | |
| Z-0007-2022 | Class I | Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application... | Abbott Molecular, Inc. | QJR | |
| Z-0006-2022 | Class I | Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application... | Abbott Molecular, Inc. | QJR | |
| Z-0005-2022 | Class I | Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m... | Abbott Molecular, Inc. | QJR | |
| Z-0004-2022 | Class I | Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m... | Abbott Molecular, Inc. | QJR | |
| Z-2591-2021 | Class II | MOSAIQ Oncology Information System | Elekta Limited | IYE | |
| Z-0114-2022 | Class II | Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used... | FLOWER ORTHOPEDICS Corporation dba Conventus Flower | HTW | |
| Z-0113-2022 | Class II | Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used... | FLOWER ORTHOPEDICS Corporation dba Conventus Flower | HTW | |
| Z-0112-2022 | Class II | Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used... | FLOWER ORTHOPEDICS Corporation dba Conventus Flower | HTW | |
| Z-0111-2022 | Class II | Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used... | FLOWER ORTHOPEDICS Corporation dba Conventus Flower | HTW | |
| Z-0158-2022 | Class II | Medtronic Sterile single-use blades that are components of the StraightShot M Series... | Medtronic Xomed, Inc. | HBE | |
| Z-0157-2022 | Class II | Medtronic sterile single-use blades that are components of the StraightShot M Series... | Medtronic Xomed, Inc. | HAW | |
| Z-0105-2022 | Class II | Thoraguard Chest Tube Kit, 20 Fr | Centese Inc. | GBX | |
| Z-0156-2022 | Class II | Medtronic sterile single-use blades that are components of the StraightShot M Series... | Medtronic Xomed, Inc. | EQJ | |
| Z-0289-2022 | Class II | SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000 | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0288-2022 | Class II | SOMATOM Confidence with software syngo.CT VB20 Model #10590100 | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0287-2022 | Class II | SOMATOM Drive with software syngo.CT VB20 Model #10431700 | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0286-2022 | Class II | SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603 | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0285-2022 | Class II | SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000 | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0284-2022 | Class II | SOMATOM Definition AS with software syngo.CT VB20 Model #8098027 | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0283-2022 | Class II | SOMATOM Force with software syngo.CT VB20 Model #10742326 | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0027-2022 | Class II | ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX). NOTE... | Exactech, Inc. | JWH | |
| Z-0026-2022 | Class II | OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components... | Exactech, Inc. | JWH | |
| Z-0025-2022 | Class II | OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE... | Exactech, Inc. | JWH | |
| Z-0024-2022 | Class II | Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner... | Exactech, Inc. | HSN | |
| Z-0023-2022 | Class II | TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following... | Exactech, Inc. | JWH | |
| Z-0022-2022 | Class II | OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM... | Exactech, Inc. | JWH | |
| Z-0021-2022 | Class II | OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK... | Exactech, Inc. | JWH |