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-0629-2022 | Class I | Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good... | Teleflex Medical | QEW | |
| Z-0628-2022 | Class I | 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC... | Teleflex Medical | QEW | |
| Z-0627-2022 | Class I | Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing... | Teleflex Medical | QEW | |
| Z-0626-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC... | Teleflex Medical | QEW | |
| Z-0625-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W... | Teleflex Medical | QEW | |
| Z-0624-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF... | Teleflex Medical | QEW | |
| Z-0623-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC... | Teleflex Medical | QEW | |
| Z-0869-2022 | Class II | MODEL: X-RAY TV SYSSTEM SONIALVISION safire17 | Shimadzu Medical Systems | JAA | |
| Z-0868-2022 | Class II | Model: X-Ray Tv System Sonialvision G4 | Shimadzu Medical Systems | JAA | |
| Z-0867-2022 | Class II | MODEL: X-RAY R/F SYSTEM FLUOROspeed X1 | Shimadzu Medical Systems | JAA | |
| Z-0722-2022 | Class II | Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format | Remel Inc | JWY | |
| Z-0510-2022 | Class II | Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL... | Compass Health Brands (Corporate Office) | ITJ | |
| Z-0568-2022 | Class I | RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the... | Base 10 Genetics Inc | QBD | |
| Z-0945-2022 | Class II | Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked | Acon Biotech (Hangzhou) Co., Ltd. | QKP | |
| Z-0721-2022 | Class II | NavitrackER Kit A: Knee, Model Number 20-8000-000-07, | Zimmer CAS | OLO | |
| Z-0677-2022 | Class II | Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long Item... | Zimmer GmbH | MBF | |
| Z-0676-2022 | Class II | Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long Item... | Zimmer GmbH | MBF | |
| Z-0675-2022 | Class II | Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM Long Item... | Zimmer GmbH | MBF | |
| Z-0674-2022 | Class II | Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long Item... | Zimmer GmbH | MBF | |
| Z-0673-2022 | Class II | Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 18 MM... | Zimmer GmbH | MBF | |
| Z-0672-2022 | Class II | Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 14 MM... | Zimmer GmbH | MBF | |
| Z-0671-2022 | Class II | Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM... | Zimmer GmbH | MBF | |
| Z-0670-2022 | Class II | Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60... | Zimmer GmbH | MBF | |
| Z-0580-2022 | Class II | Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code No. T5C4484 | Baxter Healthcare Corporation | KDJ | |
| Z-0579-2022 | Class II | Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code No. T5C4482 | Baxter Healthcare Corporation | KDJ | |
| Z-0578-2022 | Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long, REF R5C4484 | Baxter Healthcare Corporation | KDJ | |
| Z-0577-2022 | Class II | Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C4483 | Baxter Healthcare Corporation | KDJ | |
| Z-0576-2022 | Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E | Baxter Healthcare Corporation | KDJ | |
| Z-0575-2022 | Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482 | Baxter Healthcare Corporation | KDJ | |
| Z-0574-2022 | Class II | Baxter Equipo de transferencia para DP MiniCap de vida util prolongada con pinza de... | Baxter Healthcare Corporation | KDJ | |
| Z-0573-2022 | Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJ | Baxter Healthcare Corporation | KDJ | |
| Z-0572-2022 | Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483 | Baxter Healthcare Corporation | KDJ | |
| Z-0571-2022 | Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482 | Baxter Healthcare Corporation | KDJ | |
| Z-0570-2022 | Class II | Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449 | Baxter Healthcare Corporation | KDJ | |
| Z-0975-2024 | Class II | Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number... | Philips North America LLC | LNH | |
| Z-0974-2024 | Class II | Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number... | Philips North America LLC | LNH | |
| Z-0973-2024 | Class II | Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732)... | Philips North America LLC | LNH | |
| Z-0665-2022 | Class III | BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed... | Becton Dickinson & Co | JKA | |
| Z-0643-2022 | Class II | FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth | Envisiontec US LLC | EBI | |
| Z-0642-2022 | Class II | FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth | Envisiontec US LLC | EBI | |
| Z-0632-2022 | Class II | ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee... | Depuy Orthopaedics Inc. | JWH | |
| Z-0631-2022 | Class II | ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total... | Depuy Orthopaedics Inc. | JWH | |
| Z-0630-2022 | Class II | BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient... | Becton Dickinson & Co | PSZ | |
| Z-0548-2022 | Class II | INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND | Smith & Nephew, Inc. | HRS | |
| Z-0660-2022 | Class II | The Optima Coil System consists of an implantable embolization coil comprised of a... | Balt USA, LLC | HCG | |
| Z-0549-2022 | Class II | eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3... | Philips North America LLC | MSX | |
| Z-0545-2022 | Class II | CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of... | IMMY, Inc. | GMD | |
| Z-0732-2022 | Class II | RayStation/RayPlan- designed for treatment planning and analysis of radiation... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-0652-2022 | Class II | Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440 | Howmedica Osteonics Corp | JDG | |
| Z-0651-2022 | Class II | Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044 | Howmedica Osteonics Corp | JDG |