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-0217-2022 | Class II | SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T. Flex Biliary Stent System is indicated for... | Cordis US Corp. | FGE | |
| Z-0216-2022 | Class II | SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use... | Cordis US Corp. | FGE | |
| Z-0160-2022 | Class II | REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm... | Limacorporate S.p.A. | LPH | |
| Z-0159-2022 | Class II | REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm... | Limacorporate S.p.A. | LPH | |
| Z-0183-2022 | Class I | Ellume COVID-19 Home Test | Ellume Ltd | QKP | |
| Z-0367-2022 | Class II | MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized... | Mentor | FWM | |
| Z-0243-2022 | Class II | API 50 CH, Model 50300 | bioMerieux, Inc. | JSC | |
| Z-0272-2022 | Class II | ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF... | Abbott Medical | JJE | |
| Z-0271-2022 | Class II | ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF... | Abbott Medical | JJE | |
| Z-0210-2022 | Class II | Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation... | Medtronic, Inc. | NEY | |
| Z-0215-2022 | Class II | Hemodialysis Delivery System, Software Version 2.x. | Baxter Healthcare Corporation | KDI | |
| Z-0263-2022 | Class II | Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W | CooperSurgical, Inc. | HGI | |
| Z-0262-2022 | Class II | Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05 | CooperSurgical, Inc. | HGI | |
| Z-0261-2022 | Class II | Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075 | CooperSurgical, Inc. | HGI | |
| Z-0260-2022 | Class II | LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220 | CooperSurgical, Inc. | HGI | |
| Z-0259-2022 | Class II | LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120 | CooperSurgical, Inc. | HGI | |
| Z-0258-2022 | Class II | LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220 | CooperSurgical, Inc. | HGI | |
| Z-0257-2022 | Class II | LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120 | CooperSurgical, Inc. | HGI | |
| Z-0125-2022 | Class II | Atellica IM 1600 Analyzer, SMN 11066000 | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-0124-2022 | Class II | Atellica IM 1300 Analyzer, SMN 11066001 | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-0186-2022 | Class II | Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN... | Cook Incorporated | DYB | |
| Z-0185-2022 | Class II | Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The... | Cook Incorporated | DYB | |
| Z-0115-2022 | Class II | Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta... | Elekta Solutions AB | IYE | |
| Z-0317-2022 | Class II | HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL | O&M Halyard, Inc. | LZC | |
| Z-0273-2022 | Class II | Cardioblate CryoFlex Surgical Ablation Console | Medtronic Perfusion Systems | OCL | |
| Z-0179-2022 | Class II | BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal... | Becton Dickinson & Co | ||
| Z-0238-2022 | Class II | Philips Azurion systems with software releases 2.1(L1) and 2.1(L2) | Philips North America LLC | OWB | |
| Z-0213-2022 | Class II | Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model... | Philips North America LLC | JAA | |
| Z-0200-2022 | Class II | Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0264-2022 | Class II | Permobil TiLite, Models: Aero Z, and ZRA | TiSport, LLC | IOR | |
| Z-0198-2022 | Class II | ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform, | Implant Direct Sybron Manufacturing LLC | DZE | |
| Z-0197-2022 | Class II | ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform, | Implant Direct Sybron Manufacturing LLC | DZE | |
| Z-0162-2022 | Class II | SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01)... | DiaSorin Molecular LLC | QJR | |
| Z-0201-2022 | Class II | Clinician Programmer Application (CPA) model A610 Clinician Software Application | Medtronic Neuromodulation | MHY | |
| Z-0849-2022 | Class II | RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations: 4.0.0.14... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-0419-2022 | Class II | da Vinci SP Surgical systems with the following Model Name/ Model Number /... | Intuitive Surgical, Inc. | NAY | |
| Z-0241-2022 | Class II | CombiDiagnost R90 is multi-functional general R/F systems. | Philips North America LLC | JAA | |
| Z-0240-2022 | Class II | ProxiDiagnost N90 is multi-functional general R/F systems. | Philips North America LLC | OWB | |
| Z-0239-2022 | Class II | DigitalDiagnost C90 | Philips North America LLC | MQB | |
| Z-0439-2022 | Class II | VIDAS SARS-COV-2 IgG, Ref 423834-01 | bioMerieux, Inc. | QKO | |
| Z-0438-2022 | Class II | VIDAS SARS-COV-2 IgM, Ref 423833-01 | bioMerieux, Inc. | QKO | |
| Z-0437-2022 | Class II | VIDAS Lyme IgG II (LYM), REF 417401 | bioMerieux, Inc. | LSR | |
| Z-0436-2022 | Class II | VIDAS Lyme IgM II (LYM), REF 416436 | bioMerieux, Inc. | LSR | |
| Z-0435-2022 | Class II | VIDAS Estradiol II, REF 30431-01 | bioMerieux, Inc. | CHP | |
| Z-0434-2022 | Class II | Vidas Fsh, Ref 30407-01 | bioMerieux, Inc. | CGJ | |
| Z-0433-2022 | Class II | Vidas Lh, Ref 30406-01 | bioMerieux, Inc. | CEP | |
| Z-0432-2022 | Class II | VIDAS RUB IgG (RBG), REF 30226 | bioMerieux, Inc. | LFX | |
| Z-0431-2022 | Class II | VIDAS TOXO IgG Avidity (TXGA), REF 30222-01 | bioMerieux, Inc. | LGD | |
| Z-0430-2022 | Class II | VIDAS Measles IgG (MSG), REF 30219 | bioMerieux, Inc. | LJB | |
| Z-0429-2022 | Class II | VIDAS Mumps IgG (MPG), REF 30218 | bioMerieux, Inc. | LJY |