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-0098-2008 | Foundation Hip System Bipolar Modular, Size 58mm OD; Cat. #412-01-058; Sterile; assembly... | Encore Medical, LP | KWY | ||
| Z-0097-2008 | Foundation Hip System Bipolar Modular, Size 56mm OD; Cat. #412-01-056; Sterile; assembly... | Encore Medical, LP | KWY | ||
| Z-0096-2008 | Foundation Hip System Bipolar Modular, Size 54mm OD; Cat. #412-01-054; Sterile; assembly... | Encore Medical, LP | KWY | ||
| Z-0095-2008 | Foundation Hip System Bipolar Modular, Size 53mm OD; Cat. #412-01-053; Sterile; assembly... | Encore Medical, LP | KWY | ||
| Z-0094-2008 | Foundation Hip System Bipolar Modular, Size 52mm OD; Cat. #412-01-052; Sterile; assembly... | Encore Medical, LP | KWY | ||
| Z-0093-2008 | Foundation Hip System Bipolar Modular, Size 51mm OD; Cat. #412-01-051; Sterile; assembly... | Encore Medical, LP | KWY | ||
| Z-0092-2008 | Foundation Hip System Bipolar Modular, Size 50mm OD; Cat. #412-01-050; Sterile; assembly... | Encore Medical, LP | KWY | ||
| Z-0091-2008 | Foundation Hip System Bipolar Modular, Size 49mm OD; Cat. #412-01-049; Sterile; assembly... | Encore Medical, LP | KWY | ||
| Z-0090-2008 | Foundation Hip System Bipolar Modular, Size 48mm OD; Cat. #412-01-048; Sterile; assembly... | Encore Medical, LP | KWY | ||
| Z-0089-2008 | Foundation Hip System Bipolar Modular, Size 47mm OD; Cat. #412-01-047; Sterile; assembly... | Encore Medical, LP | KWY | ||
| Z-0088-2008 | Foundation Hip System Bipolar Modular, Size 46mm OD; Cat. #412-01-046; Sterile; assembly... | Encore Medical, LP | KWY | ||
| Z-0087-2008 | Foundation Hip System Bipolar Modular, Size 45mm OD; Cat. #412-01-045; Sterile; assembly... | Encore Medical, LP | KWY | ||
| Z-0086-2008 | Foundation Hip System Bipolar Modular, Size 44mm OD; Cat. #412-01-044; Sterile; assembly... | Encore Medical, LP | KWY | ||
| Z-0085-2008 | Foundation Hip System Bipolar Modular, Size 43mm OD; Cat. #412-01-043; Sterile; assembly... | Encore Medical, LP | KWY | ||
| Z-0084-2008 | Foundation Hip System Bipolar Modular, Size 42mm OD; Cat. #412-01-042; Sterile; assembly... | Encore Medical, LP | KWY | ||
| Z-0083-2008 | Foundation Hip System Bipolar Modular, Size 41mm OD; Cat. #412-01-041; Sterile; assembly... | Encore Medical, LP | KWY | ||
| Z-0082-2008 | Foundation Hip System Bipolar Modular, Size 40mm OD; Cat. #412-01-040; Sterile; assembly... | Encore Medical, LP | KWY | ||
| Z-0112-2008 | Blood glucose meter, marketed with multiple brand names including: Precision Xtra New and... | Abbott Medical | NBW | ||
| Z-0173-2008 | Cyberonics VNS Therapy Perrennia Lead, Model #303; Sterile, Single use only; distributed... | LivaNova USA, Inc. | LYJ | ||
| Z-0172-2008 | Cyberonics VNS Therapy Bipolar Lead, Model #302; Sterile, Single use only; Distributed by... | LivaNova USA, Inc. | LYJ | ||
| Z-0171-2008 | Cyberonics Neuro Cyberonics Prosthesis System NCP Bipolar Lead, Model #300; Sterile... | LivaNova USA, Inc. | LYJ | ||
| Z-0455-2009 | Cytomics FC 500 Flow Cytometry System with CXP Software, Part Numbers: 626553, Version 2.2 | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0274-2008 | Precision 500D Classical R&F System with control room PC; Image-intensified fluoroscopic... | GE Healthcare | JAA | ||
| Z-0075-2008 | Sunisa Flexi-DT Table, Model Numbers: 51335678, 2269647, 2242088-2, 5141609-2, 5115763... | GE Healthcare | KXJ | ||
| Z-0041-2008 | PEMView Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner, for... | CMR Naviscan Corporation | KPS | ||
| Z-1227-2007 | Medtronic Intersept 3608 Sterile tubing (8') 1/2 x 3/32 in. Quantity 10, Lot 7626621... | Medtronic Perfusion Systems | DWE | ||
| Z-1192-2007 | Newport HT50 Ventilator (all Models) | Newport Medical Instruments, Inc. | CBK | ||
| Z-1231-2007 | Triathlon X3 Total Stabilizer + Tibial Insert For use with Triathlon Universal... | Howmedica Osteonics Corp | JWH | ||
| Z-0795-2010 | Scorpio PS Femoral Waffle (No post) and LFIT; Use only with Scorpio PS Tibial Bearing... | Howmedica Osteonics Corp | JWH | ||
| Z-0191-2008 | Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size... | Allez Spine, LLC | MNI | ||
| Z-0190-2008 | Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size... | Allez Spine, LLC | MNI | ||
| Z-0189-2008 | Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size... | Allez Spine, LLC | MNI | ||
| Z-0188-2008 | Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size... | Allez Spine, LLC | MNI | ||
| Z-0187-2008 | Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size... | Allez Spine, LLC | MNI | ||
| Z-0186-2008 | Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size... | Allez Spine, LLC | MNI | ||
| Z-1263-2007 | Altaire Shoulder Coil, an accessory to the Altaire MRI system. The shoulder coil is a... | FUJIFILM Healthcare Americas Corporation | LNH | ||
| Z-0039-2008 | STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic. | Diagnostica Stago, Inc. | GKP | ||
| Z-1236-2007 | Normal Saline 10ml in 12ml Syringe. The product is shipped in 120 units per carton. | B Braun Medical Inc | NGT | ||
| Z-1235-2007 | Normal Saline 3ml in 12ml Syringe. The product is shipped 120 units per carton | B Braun Medical Inc | NGT | ||
| Z-0133-2008 | Harleco May and Grunwald's Stain; 0.17% w/v; Methanol Solution UN1230; EMD Chemicals... | EMD Millipore Corporation | KQC | ||
| Z-0178-2008 | Capnostream20 Monitor with Masimo Pulse Oximetry Module - Part Number: CS 08659 - Oridion... | Oridion Capnography, Inc. | DQA | ||
| Z-0177-2008 | Capnostream20 Monitor with Nellcor Pulse Oximetry Module--Part Number: CS 08657- Oridion... | Oridion Capnography, Inc. | DQA | ||
| Z-1242-2008 | Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04... | AGFA Healthcare Corp. | LLZ | ||
| Z-0852-2008 | Siemens Mevatron Linear Accelerator Systems; Mevatron M 7440, Part No.: 5672977... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0851-2008 | Siemens Mevatron Linear Accelerator Systems: KD2, K 7767, K 8067, KD, KDS and KDS2... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0850-2008 | Siemens Primus Linear Accelerator System, PRIMART MX Linear Accelerator System; PRIMUS... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-1230-2007 | 5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number... | Mentor | MUU | ||
| Z-1228-2007 | NxStage Cartridge Express, CAR-170, for hemodialysis. | NxStage Medical Inc | KDI | ||
| Z-0001-2008 | Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and... | Bio-Logic Systems Corp. | GWQ | ||
| Z-0301-2008 | Abbott Diagnostics CELL-DYN Sapphire Hemoglobin Reagent Analyzer Syringes, List Number... | Abbott Medical | GKZ |