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-1689-2015 | Class II | Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult... | Maquet Cardiovascular Us Sales, LLC | DTZ | |
| Z-1279-2015 | Class II | GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all... | GE Healthcare | KPS | |
| Z-1684-2015 | Class II | CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000... | Cerenovus, Inc. | LKK | |
| Z-1479-2015 | Class II | SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part... | SPINEFRONTIER, Inc. dba LESspine Innovations | FTY | |
| Z-1673-2015 | Class II | LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthopedic surgery. | Depuy Orthopaedics Inc. | NJL | |
| Z-1672-2015 | Class II | LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis... | Depuy Orthopaedics Inc. | NJL | |
| Z-1444-2015 | Class II | Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat... | Hardy Diagnostics | JSI | |
| Z-1290-2015 | Class I | Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system... | Cardiovascular Systems Incorporated | MCX | |
| Z-1310-2015 | Class II | RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-1288-2015 | Class II | LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low... | Ossur Iceland ehf. | ISH | |
| Z-1304-2015 | Class II | da Vinci Xi Surgical System, IS4000; ASSY,USM,IS4000, Material number: 380647-20 and... | Intuitive Surgical, Inc. | NAY | |
| Z-1303-2015 | Class II | da Vinci Xi Surgical System, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000, Material number... | Intuitive Surgical, Inc. | NAY | |
| Z-1302-2015 | Class II | da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Material number... | Intuitive Surgical, Inc. | NAY | |
| Z-2083-2015 | Class II | The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79... | Maquet Cardiovascular Us Sales, LLC | BSZ | |
| Z-1820-2015 | Class II | Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece. | Hill-Rom Inc. | HMX | |
| Z-1451-2015 | Class II | Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA... | Baxter Healthcare Corporation | FRN | |
| Z-2055-2015 | Class III | Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human... | Volk Optical Inc | HJI | |
| Z-1685-2015 | Class III | Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk... | Volk Optical Inc | HJK | |
| Z-1614-2015 | Class II | Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extenders are... | Howmedica Osteonics Corp | JWH | |
| Z-1376-2015 | Class II | GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines. Model numbers... | GE Healthcare | BSZ | |
| Z-1641-2015 | Class II | ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The... | Ethicon Endo-Surgery Inc | GDW | |
| Z-1400-2015 | Class II | CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene... | CIVCO Medical Instruments Co., Inc. | ITX | |
| Z-1322-2015 | Class II | The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity... | Ossur Iceland ehf. | ISW | |
| Z-1364-2015 | Class II | Ziploop Button Product Usage: The Ziploop Button is a non-resorbable system intended to... | Zimmer GmbH | JDR | |
| Z-1363-2015 | Class II | ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligament Fixation... | Zimmer GmbH | JDR | |
| Z-1368-2015 | Class II | LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmology... | Quest Medical, Inc | HNL | |
| Z-1353-2015 | Class II | Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as... | DSM Biomedical, Inc. | LMH | |
| Z-1797-2015 | Class II | Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management. | Amerx Health Care Corp. | MGQ | |
| Z-1480-2015 | Class II | Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers). | CAPTIVA SPINE, Inc. | LXH | |
| Z-1403-2015 | Class III | Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, IVD... | bioMerieux, Inc. | LTW | |
| Z-1402-2015 | Class III | Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per container... | bioMerieux, Inc. | LTW | |
| Z-1401-2015 | Class III | Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container... | bioMerieux, Inc. | LTW | |
| Z-1336-2015 | Class II | Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter... | Boston Scientific Corporation | FGE | |
| Z-1355-2015 | Class II | Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and... | Boston Scientific Corporation | FGE | |
| Z-1242-2015 | Class II | LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04... | Biosense Webster Inc | DRF | |
| Z-1350-2015 | Class II | Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electrode SBT-60... | Leonhard Lang GmbH | DRX | |
| Z-1294-2015 | Class III | LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is... | LeMaitre Vascular Inc. | DWQ | |
| Z-1398-2015 | Class II | QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension... | Siemens Healthcare Diagnostics Inc. | CEM | |
| Z-1352-2015 | Class II | Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and... | Synthes GmbH | HSB | |
| Z-2100-2017 | Class II | Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment... | Mobius Medical Systems, LP | IYE | |
| Z-1357-2015 | Class II | RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip... | Depuy Orthopaedics Inc. | LXH | |
| Z-1276-2015 | Class I | Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select... | Medtronic, Inc. | DYB | |
| Z-1552-2015 | Class II | 2008 Series Hemodialysis Machines: 2008K2 with the following product code and... | Fresenius Medical Care Renal Therapies Group, LLC | KDI | |
| Z-1551-2015 | Class II | 2008 Series Hemodialysis Machines: 2008K with the following product code and description... | Fresenius Medical Care Renal Therapies Group, LLC | KDI | |
| Z-1550-2015 | Class II | 2008 Series Hemodialysis Machines: 2008T with the following product code and description... | Fresenius Medical Care Renal Therapies Group, LLC | KDI | |
| Z-1549-2015 | Class II | 2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX... | Fresenius Medical Care Renal Therapies Group, LLC | KDI | |
| Z-1515-2015 | Class II | OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I... | Advanced Medical Optics, Inc. | OOE | |
| Z-1683-2015 | Class II | Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International... | OptiMedica Corp. | OOE | |
| Z-1362-2015 | Class II | GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number... | Orthopediatrics Canada ULC | HSB | |
| Z-1323-2015 | Class II | Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E) is a bipolar... | ArthroCare Corporation | GEI |