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-1129-2022 | Class II | Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200 | Medtronic Neuromodulation | MRU | |
| Z-1128-2022 | Class II | Percept BrainSense Implantable Neurostimulator (INS), Model B35200 | Medtronic Neuromodulation | MHY | |
| Z-1026-2022 | Class II | Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical... | restor3d, Inc. | LXH | |
| Z-1123-2022 | Class II | Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim... | Medtronic Neuromodulation | LGW | |
| Z-1110-2022 | Class II | Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare... | Medtronic, Inc. | DSQ | |
| Z-1121-2022 | Class II | The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade... | Accriva Diagnostics, Inc. | JOZ | |
| Z-0576-2024 | Class II | The device is a whole-body CT x-ray system. The acquired x-ray transmission data is... | Philips North America LLC | JAK | |
| Z-1059-2022 | Class II | VITEK 2 Systems and VITEK 2 with MYLA. | bioMerieux, Inc. | LON | |
| Z-1254-2022 | Class II | MedMinder Medication Dispenser- Intended to serve as a medication reminder to promote... | MedMinder Systems, Inc. | ILQ | |
| Z-1011-2022 | Class II | Smart Toe II Intramedullary Arthrodesis Implant | Stryker Corp. | HTY | |
| Z-1116-2022 | Class II | Olympus Uretero-reno videoscope, Model No. URF-V2 | OLYMPUS Corporation of the Americas | NWB | |
| Z-1114-2022 | Class II | VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793 | Ortho-Clinical Diagnostics, Inc. | CFT | |
| Z-1113-2022 | Class II | VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198 | Ortho-Clinical Diagnostics, Inc. | CEP | |
| Z-1112-2022 | Class II | VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922 | Ortho-Clinical Diagnostics, Inc. | CGJ | |
| Z-1097-2022 | Class III | CK MB Calibrator, Catalogue Number CK2393 | Randox Laboratories, Limited | CGS | |
| Z-1215-2022 | Class II | BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa... | Becton, Dickinson and Company, BD Biosciences | MVU | |
| Z-1214-2022 | Class II | BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti-Kappa... | Becton, Dickinson and Company, BD Biosciences | MVU | |
| Z-1117-2022 | Class II | CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and... | Caire, Inc. | CAW | |
| Z-1035-2022 | Class II | K-Wire, 1.35 mm x 170 mm | Arthrex GmbH | LXH | |
| Z-0966-2022 | Class I | Puritan Bennett 980 Series Ventilator | Medtronic, Inc. | CBK | |
| Z-1053-2022 | Class II | STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code... | Ethicon, Inc | GAM | |
| Z-0954-2022 | Class II | Inactivated macrolide and quinolone-resistant Mycoplasma genitalium | Microbiologics, Inc. | OHQ | |
| Z-0957-2022 | Class II | Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model... | Abbott Medical | OAE | |
| Z-0956-2022 | Class II | Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F... | Abbott Medical | OAE | |
| Z-1043-2022 | Class II | Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile... | Medtronic, Inc. | PRC | |
| Z-1042-2022 | Class II | Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only... | Medtronic, Inc. | ONU | |
| Z-1001-2022 | Class II | TearCare version 1.0 SmartHubs | Sight Sciences, Inc. | ORZ | |
| Z-1119-2022 | Class II | Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4... | STERIS Corporation | EFQ | |
| Z-1118-2022 | Class II | Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2... | STERIS Corporation | EFQ | |
| Z-0955-2022 | Class II | Inactivated macrolide-resistant Mycoplasma genitalium | Microbiologics, Inc. | OHQ | |
| Z-1040-2022 | Class II | ACS Cath Lab Pack | American Contract Systems, Inc. | OES | |
| Z-1039-2022 | Class II | ACS Lap Chole Pack | American Contract Systems, Inc. | FDE | |
| Z-1038-2022 | Class II | ACS IR - Angio Pack | American Contract Systems, Inc. | OIP | |
| Z-1037-2022 | Class II | 1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack | American Contract Systems, Inc. | OJH | |
| Z-1036-2022 | Class II | 1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray | American Contract Systems, Inc. | OJG | |
| Z-1032-2022 | Class I | Avanos Cortrak 2 Enteral Access System (EAS) | Halyard Health | KNT | |
| Z-1101-2022 | Class II | Prevantics swabs and/or swabsticks contained inside the following Aligned Medical... | Windstone Medical Packaging, Inc. | KDD | |
| Z-1051-2022 | Class II | Regard brand CABG Pack A and B - Spartanburg | ROi CPS LLC | OEZ | |
| Z-0942-2022 | Class II | ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1 | Varian Medical Systems Imaging Laboratory GmbH | IYE | |
| Z-1030-2022 | Class II | Restrata, Part Number RWM1-2X2 | Acera Surgical, Inc. C/O Linda Braddon, PhD | FRO | |
| Z-1013-2022 | Class II | WAVES WCM Kidney Cassette Module | Waters Medical Systems LLC | KDN | |
| Z-0943-2022 | Class II | Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article... | Breas Medical AB | CBK | |
| Z-1100-2022 | Class II | Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly... | Den-Mat Holdings, LLC | ELW | |
| Z-1034-2022 | Class II | Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound... | OLYMPUS Corporation of the Americas | ITX | |
| Z-1006-2022 | Class II | Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions... | ROi CPS LLC | LRS | |
| Z-1005-2022 | Class II | Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging... | ROi CPS LLC | MLS | |
| Z-1004-2022 | Class II | Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging... | ROi CPS LLC | OHM | |
| Z-0877-2022 | Class II | Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro... | Hologic, Inc. | NJR | |
| Z-0999-2022 | Class II | da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45... | Intuitive Surgical, Inc. | NAY | |
| Z-1212-2023 | Class II | LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device... | LetsGetChecked Inc | PQD |