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-3286-2018 | Class II | Bronchovidescope BF-1T240 | OLYMPUS Corporation of the Americas | EOQ | |
| Z-3285-2018 | Class II | Bronchovideoscope BF-1T180 | OLYMPUS Corporation of the Americas | EOQ | |
| Z-3284-2018 | Class II | Bronchofiberscope F-1T160 | OLYMPUS Corporation of the Americas | EOQ | |
| Z-3283-2018 | Class II | Bronchovideoscope BF-160 | OLYMPUS Corporation of the Americas | EOQ | |
| Z-3277-2018 | Class II | Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Wide-Field Elite... | Bausch & Lomb Incorporated | HQE | |
| Z-3276-2018 | Class II | Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Mid-Field Elite... | Bausch & Lomb Incorporated | HQE | |
| Z-3275-2018 | Class II | Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Wide-Field Elite... | Bausch & Lomb Incorporated | HQE | |
| Z-3274-2018 | Class II | Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Mid-Field Elite... | Bausch & Lomb Incorporated | HQE | |
| Z-3273-2018 | Class II | Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Wide-Field... | Bausch & Lomb Incorporated | HQE | |
| Z-3272-2018 | Class II | Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Mid-Field Elite... | Bausch & Lomb Incorporated | HQE | |
| Z-3271-2018 | Class II | Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in... | Bausch & Lomb Incorporated | HQE | |
| Z-3270-2018 | Class II | Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Wide-Field... | Bausch & Lomb Incorporated | HQE | |
| Z-3269-2018 | Class II | Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Mid-Field Elite... | Bausch & Lomb Incorporated | HQE | |
| Z-3268-2018 | Class II | Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in... | Bausch & Lomb Incorporated | HQE | |
| Z-3267-2018 | Class II | Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wide-Field... | Bausch & Lomb Incorporated | HQE | |
| Z-3266-2018 | Class II | Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid-Field Elite... | Bausch & Lomb Incorporated | HQE | |
| Z-3265-2018 | Class II | Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in... | Bausch & Lomb Incorporated | HQE | |
| Z-0010-2020 | Class II | ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U... | Implant Direct Sybron Manufacturing LLC | DZE | |
| Z-0178-2020 | Class I | Minimed Model 503 Remote Transmitter (MMT-503, MMT-503EU, MMT-503NA, MMT-503US) for use... | Medtronic, Inc. | LZG | |
| Z-0177-2020 | Class I | Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE, MMT-500RCH... | Medtronic, Inc. | LZG | |
| Z-0062-2019 | Class III | Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar... | Dannoritzer Medizintechnik GmbH & Co. KG | GEI | |
| Z-0300-2019 | Class II | Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 or 7042034)... | Siemens Medical Solutions USA, Inc. | KPR | |
| Z-0299-2019 | Class II | Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model number 7042018 or... | Siemens Medical Solutions USA, Inc. | KPR | |
| Z-0298-2019 | Class II | AXIOM Multix MT (model number 8395415 or 8395399 or 8395381), a patient table used in... | Siemens Medical Solutions USA, Inc. | IZZ | |
| Z-0091-2019 | Class II | Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is... | Reckitt Benckiser LLC | MOL | |
| Z-0297-2019 | Class II | Multix Fusion system is a radiographic system: Models: Multix Fusion Analog (model number... | Siemens Medical Solutions USA, Inc. | KPR | |
| Z-0101-2019 | Class II | Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology... | AGFA Healthcare Corp. | LLZ | |
| Z-3252-2018 | Class II | Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to... | Zimmer GmbH | MBI | |
| Z-3192-2018 | Class II | Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388 | Invivo Corporation | MWI | |
| Z-2917-2018 | Class II | MOSAIQ Oncology Information System | Elekta Limited | IYE | |
| Z-0283-2019 | Class III | Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with... | Neogen Culture Media | JSI | |
| Z-0284-2019 | Class III | Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazone for the... | Neogen Culture Media | JSJ | |
| Z-3250-2018 | Class II | Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment, Model Number... | Zimmer GmbH | JWH | |
| Z-3249-2018 | Class II | Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number... | Zimmer GmbH | JWH | |
| Z-3016-2018 | Class I | ultraView SISH DNP Detection Kit, Catalog Number 05907136001, model... | Ventana Medical Systems Inc | PPM | |
| Z-3015-2018 | Class I | NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model... | Ventana Medical Systems Inc | NJT | |
| Z-3014-2018 | Class I | INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295... | Ventana Medical Systems Inc | MAQ | |
| Z-3013-2018 | Class I | CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713... | Ventana Medical Systems Inc | PRB | |
| Z-3012-2018 | Class I | CINtec p16 Histology (250), Catalog Number 06695230001, Model... | Ventana Medical Systems Inc | PRB | |
| Z-3011-2018 | Class I | CINtec Histology (250), Catalog Number 06680011001, model 725-4793 Immunohistochemistry... | Ventana Medical Systems Inc | PRB | |
| Z-3010-2018 | Class I | VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model... | Ventana Medical Systems Inc | OWF | |
| Z-3009-2018 | Class I | VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010... | Ventana Medical Systems Inc | NJT | |
| Z-3008-2018 | Class I | VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092... | Ventana Medical Systems Inc | PPM | |
| Z-3007-2018 | Class I | CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog... | Ventana Medical Systems Inc | MYA | |
| Z-3006-2018 | Class I | CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog... | Ventana Medical Systems Inc | MXZ | |
| Z-3005-2018 | Class I | ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemistry (IHC)... | Ventana Medical Systems Inc | IBG | |
| Z-3004-2018 | Class I | ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05269814001... | Ventana Medical Systems Inc | NJT | |
| Z-3003-2018 | Class I | ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135... | Ventana Medical Systems Inc | NJT | |
| Z-3002-2018 | Class I | ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097... | Ventana Medical Systems Inc | PPM | |
| Z-3001-2018 | Class I | iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model... | Ventana Medical Systems Inc | NJT |