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-0211-2022 | Class II | QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model /... | Z-Medica, LLC | FRO | |
| Z-0428-2022 | Class II | Vidas B.r.a.h.m.s. Procalcitonin Pct, Ref 30450-01 | bioMerieux, Inc. | PRI | |
| Z-0427-2022 | Class II | VIDAS DEX@, Dimer Exclusion II, REF 30455-01 | bioMerieux, Inc. | DAP | |
| Z-0426-2022 | Class II | VIDAS Clostridium Difficile GDH, REF 30125-01 | bioMerieux, Inc. | MCB | |
| Z-0425-2022 | Class II | VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01 | bioMerieux, Inc. | LLH | |
| Z-0424-2022 | Class II | VIDAS PRG Progesterone, REF 30409-01 | bioMerieux, Inc. | JLS | |
| Z-0118-2022 | Class I | ROSA One 3.1 Brain application The device is intended for the spatial positioning and... | MedTech SAS | HAW | |
| Z-0196-2022 | Class II | ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866 | Siemens Healthcare Diagnostics Inc. | QKP | |
| Z-0195-2022 | Class II | Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861 | Siemens Healthcare Diagnostics Inc. | QKP | |
| Z-0275-2022 | Class II | The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main... | Intuitive Surgical, Inc. | NAY | |
| Z-0176-2022 | Class II | ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is... | OLYMPUS Corporation of the Americas | PMU | |
| Z-0123-2022 | Class II | EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232 | Philips North America LLC | IYN | |
| Z-0091-2022 | Class I | Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave... | Datascope Corp. | DSP | |
| Z-0234-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DXE | |
| Z-0233-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DXE | |
| Z-0232-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DXE | |
| Z-0231-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DXE | |
| Z-0181-2022 | Class II | Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151 | Siemens Healthcare Diagnostics Inc. | CEK | |
| Z-0180-2022 | Class II | Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543 | Siemens Healthcare Diagnostics Inc. | CEK | |
| Z-0143-2022 | Class II | 6.5Mmx165mm Cannulated Screw | Smith & Nephew, Inc. | HWC | |
| Z-0236-2022 | Class II | BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex... | Bio-Rad Laboratories Inc. | LIP | |
| Z-0235-2022 | Class II | BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The... | Bio-Rad Laboratories Inc. | LIP | |
| Z-0116-2022 | Class II | Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise... | Elekta Limited | IYE | |
| Z-0199-2022 | Class II | The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made... | Medrad, Inc. | DXT | |
| Z-2563-2021 | Class II | Elekta Monaco - Product Usage: used to make treatment plans for patients with... | Elekta Limited | MUJ | |
| Z-0003-2022 | Class II | Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit... | Medtronic Perfusion Systems | DWF | |
| Z-0072-2022 | Class II | ARCH Leg Positioning System | Innovative Orthopedic Technologies, LLC | BWN | |
| Z-0161-2022 | Class II | Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths) | Kinsman Enterprises Inc | IKZ | |
| Z-0120-2022 | Class II | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use... | Ortho-Clinical Diagnostics, Inc. | QKO | |
| Z-0087-2022 | Class II | FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of... | Inpeco S.p.A. | CEM | |
| Z-0184-2022 | Class II | FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6... | Karl Storz Endoscopy-America, Inc. | CAL | |
| Z-0131-2022 | Class II | Standard IUD Insertion Kit | Gyn-Disposables, Inc. | HDC | |
| Z-0130-2022 | Class II | Foundation Kit | Gyn-Disposables, Inc. | HDC | |
| Z-0129-2022 | Class II | Endometrial Biopsy Kit | Gyn-Disposables, Inc. | HDC | |
| Z-0128-2022 | Class II | IUD Insertion Kit | Gyn-Disposables, Inc. | HDC | |
| Z-0127-2022 | Class II | IUD Insertion Pack | Gyn-Disposables, Inc. | HDC | |
| Z-0126-2022 | Class II | Tenaculum, Plastic | Gyn-Disposables, Inc. | HDC | |
| Z-0109-2022 | Class II | Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the... | Draeger, Inc. | CBK | |
| Z-0108-2022 | Class II | Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation... | Draeger, Inc. | CBK | |
| Z-0848-2022 | Class II | TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-0074-2022 | Class II | ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part... | Depuy Orthopaedics Inc. | JWH | |
| Z-0173-2022 | Class II | C315-HIS Delivery Catheter | Medtronic, Inc. | DQY | |
| Z-2587-2021 | Class I | GENOSYL DS (Delivery System) console, for use as a vasodilator. | Vero Biotech Inc. | MRN | |
| Z-0306-2022 | Class II | BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System... | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | |
| Z-0249-2022 | Class II | Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification... | FUJIFILM Biosciences Inc. | MQL | |
| Z-0248-2022 | Class II | Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification... | FUJIFILM Biosciences Inc. | MQL | |
| Z-0147-2022 | Class II | Kit: Central Line Dres Change 20/Cs | Medical Action Industries, Inc. 306 | PEZ | |
| Z-2616-2021 | Class II | Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75... | Datascope Corp. | DSP | |
| Z-2615-2021 | Class II | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31... | Datascope Corp. | DSP | |
| Z-0076-2022 | Class II | Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75... | Datascope Corp. | DSP |