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-0145-06 | Fleixiflo Quantum Enteral Pump. | Abbott Medical | FRN | ||
| Z-1177-2007 | APhL HRP IgM ELISA Kit; Ref. #LAPL-K-HRP-001M; distributed by Louisville APL Diagnostics... | Louisville Apl Diagnostics Inc | MID | ||
| Z-1176-2007 | APhL HRP IgG ELISA Kit; Ref. #LAPL-K-HRP-001G; distributed by Louisville APL Diagnostics... | Louisville Apl Diagnostics Inc | MID | ||
| Z-1175-2007 | APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; distributed by Louisville APL... | Louisville Apl Diagnostics Inc | MID | ||
| Z-0293-2007 | Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040. | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0292-2007 | Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0150-06 | Atlas DR, Models V-240 | Abbott Medical | LWS | ||
| Z-0149-06 | Atlas VR, Models V-199 | Abbott Medical | LWS | ||
| Z-0265-06 | Custom heart lung perfusion packs | LivaNova USA, Inc. | DTM | ||
| Z-0148-06 | Photo Micro VR/DR Models V-232 | Abbott Medical | NIK | ||
| Z-0147-06 | Photo Micro VR/DR Models V-194 | Abbott Medical | LWS | ||
| Z-0146-06 | Photo DR, Model V-230HV Implantable Cardioverter Defibrillator | Abbott Medical | LWS | ||
| Z-0138-06 | Breast Biopsy Aiming Device. Magnetic Resonance Imaging System. Model number 5728735 | Siemens Medical Solutions USA, Inc. | LNH | ||
| Z-0097-06 | CeeOn Heparin SurfaceModifie (HSM) PMMA One-Piece Anterior Chamber IOLs (Model: HSM65) | Advanced Medical Optics, Inc. | HQL | ||
| Z-0096-06 | CeeOn Heparin Surface Modified (HSM) PMMA One-Piebe Posterior Chambet- IOLs (Models:722C... | Advanced Medical Optics, Inc. | HQL | ||
| Z-0095-06 | CeeOn EDGE Silicone Posterior Chamber IOLs (Modelsl 911A and 913A) | Advanced Medical Optics, Inc. | HQL | ||
| Z-0094-06 | Tecnis Multifocal Silicone Posterior Chamber IOLs (Model: ZM900) | Advanced Medical Optics, Inc. | HQL | ||
| Z-0093-06 | Tecnis Monofocal Silicone Posterior Chamber IOLs (Models: Z9000 and Z9001) | Advanced Medical Optics, Inc. | HQL | ||
| Z-1046-05 | HeartSine Samaritan AED Defibrillators Models: SAM 001, SAM 002, SAM 003. | HeartSine Technologies Ltd | MKJ | ||
| Z-0170-06 | Gamma System, Cross Screw, Self-Tapping (Cleared under Grosse and Kempf Locking Nail... | Howmedica Osteonics Corp | HWC | ||
| Z-0169-06 | T2 System, Condyle Screw | Howmedica Osteonics Corp | HWC | ||
| Z-0168-06 | S2 System, Condyle Screw | Howmedica Osteonics Corp | HWC | ||
| Z-0167-06 | S2 System, Locking Screw Fully Threaded | Howmedica Osteonics Corp | HWC | ||
| Z-0166-06 | S2 System, Locking Screw Partially Threaded | Howmedica Osteonics Corp | HWC | ||
| Z-0183-06 | Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System... | Theken Companies LLC | LXH | ||
| Z-0164-06 | Cardinal Health Presource PBDS Latex Free Convenience Kits; sterile single use disposable... | Medtronic, Inc. | LRO | ||
| Z-0163-06 | Cardinal Health Custom Sterile Latex Free Convenience Kits; sterile single use disposable... | Medtronic, Inc. | LRO | ||
| Z-1223-2011 | Leksell GammaPlan, Model 5.34. Intended to be used for planning the dosimetry of... | Elekta Limited | IWB | ||
| Z-1159-2010 | Elekta SL Series/Precise Digital Accelerator. The product is used with radiation... | Elekta Limited | IYE | ||
| Z-0091-06 | Zimmer brand Sirus Intramedullary femur nail system step reamer 0 mm, 6.5/4.5 mm... | Zimmer GmbH | GFG | ||
| Z-0136-06 | Nichols Advantage EPO Calibration Verifiers, Catalog #63-7512 | Nichols Institute Diagnostics | GGT | ||
| Z-0892-06 | VITALITY DS (model T125) and VITALITY 2 (models T165, 175) ICD (implantable cardiac... | Boston Scientific Corporation | LWP | ||
| Z-0891-06 | CONTAK RENEWAL 4 CRT-D (model no. H190, H195, H199). Cardiac Resynchronization Therapy... | Boston Scientific Corporation | NIK | ||
| Z-0890-06 | CONTAK RENEWAL 3 CRT-D (model no. H170, H175, H177, H179). Cardiac Resynchronization... | Boston Scientific Corporation | NIK | ||
| Z-1387-06 | Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzers, ABL-800 series, manufactured from... | Radiometer America, Inc | JFP | ||
| Z-1386-06 | Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-700 Series, manufactured... | Radiometer America, Inc | JFP | ||
| Z-0137-06 | Vitros ECi Immunodiagnostic System, sold as Cat. #863 3893; Cat. #192 2814 (Vitros ECiQ)... | Ortho-Clinical Diagnostics, Inc. | KHO | ||
| Z-0114-06 | K 520711-2, Hercep Test, 35Test, HER2, Protein | Agilent Technologies, Inc. | MVC | ||
| Z-0088-06 | Misys Laboratory version 6.1 - Microbiology Module | CliniSys, Inc | JQP | ||
| Z-0113-06 | K 520411-2, Hercep Test, 35Test, HER2, Protein | Agilent Technologies, Inc. | MVC | ||
| Z-0135-06 | LifeShield Latex-Free HEMA Y-Type Blood PlumSet, Nonvented, 122 inch, with 210 Micron... | Abbott Medical | BRZ | ||
| Z-0134-06 | LifeShield Latex-Free HEMA Y-Type Blood PlumSet, Nonvented, 122 inch, with 210 Micron... | Abbott Medical | BRZ | ||
| Z-0133-06 | LifeShield Latex-Free HEMA Blood PlumSet; Nonvented, 100 inch, with 210 Micron Filter... | Abbott Medical | BRZ | ||
| Z-0178-06 | Bard RespiShield * Closed Suction System with InnoValve * Endotracheal Start Kit * QTY 1... | C.R. Bard Inc | BSY | ||
| Z-0275-06 | Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter... | Baxter Healthcare Renal Div | KDI | ||
| Z-0105-06 | Sopha Medical Vision DST / DST-XL Digital vatiable angle Nuclear Imaging System | GE Healthcare | KPS | ||
| Z-0039-06 | Datex-Ohmeda Aespire Carestation. This device is not marketed in the US. | GE Healthcare | BSZ | ||
| Z-0038-06 | Datex-Ohmeda S/5 Aespire Anesthesia System 7900 | GE Healthcare | BSZ | ||
| Z-0037-06 | Datex-Ohmeda S/5 Aespire Anesthesia System 7100 | GE Healthcare | BSZ | ||
| Z-0368-06 | Cook brand Embolization Coils, stainless steel, sterile, 20 MM diameter, .038'' (0.97 mm)... | Cook Incorporated | KRD |