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-2233-2019 | Class II | Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151812 | Zimmer GmbH | JDI | |
| Z-2232-2019 | Class II | Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151811 | Zimmer GmbH | JDI | |
| Z-2231-2019 | Class II | Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151810 | Zimmer GmbH | JDI | |
| Z-1965-2019 | Class II | Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D... | GE Healthcare | IYN | |
| Z-1964-2019 | Class II | Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D | GE Healthcare | IYN | |
| Z-1891-2020 | Class II | daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI... | Intuitive Surgical, Inc. | GAG | |
| Z-1890-2020 | Class II | daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI... | Intuitive Surgical, Inc. | GAG | |
| Z-0350-2020 | Class II | Universal Sexual Health Testing Kit | Privapath Diagnostics Ltd | N/A | |
| Z-2173-2019 | Class II | SNAG FREE SUTURE TRAY Kit Code: SUT14355 - Product Usage: Kit is used for laceration... | Centurion Medical Products, LP | LRP | |
| Z-2172-2019 | Class II | LACERATION TRAY Kit Code: SUT18370 - Product Usage: Kit is used for laceration repairs... | Centurion Medical Products, LP | LRP | |
| Z-2171-2019 | Class II | UNIVERSAL BLOCK TRAY Kit Code: MNS6645 - Product Usage: Kit is used for regional... | Centurion Medical Products, LP | LRP | |
| Z-2170-2019 | Class II | DRIVELINE MANAGEMENT SYSTEM 1 DAILY Kit Code: DT18440A - Product Usage: Kit is used for... | Centurion Medical Products, LP | OXQ | |
| Z-2169-2019 | Class II | DRIVELINE MANAGEMENT TRAY Kit Code: DT17780B - Product Usage: Kit is used for Driveline... | Centurion Medical Products, LP | OXQ | |
| Z-2168-2019 | Class II | HIGH DRAINAGE LVAD TRAY Kit Code: DM950 - Product Usage: Kit is used for Driveline... | Centurion Medical Products, LP | OXQ | |
| Z-2167-2019 | Class II | DAILY DRIVELINE KIT Kit Code: DM940 - Product Usage: Kit is used for Driveline... | Centurion Medical Products, LP | OXQ | |
| Z-2166-2019 | Class II | LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used for Left... | Centurion Medical Products, LP | OXQ | |
| Z-2165-2019 | Class II | NEONATAL PICC INSERTION TRAY Kit Code: CVI2310 - Product Usage: Kit is used for... | Centurion Medical Products, LP | LRS | |
| Z-2164-2019 | Class II | CIRCUMCISION TRAY Kit Code: CIT2650H - Product Usage: Kit is used for performing... | Centurion Medical Products, LP | OHG | |
| Z-2163-2019 | Class II | CIRCUMCISION TRAY Kit Code: CIT2245 - Product Usage: Kit is used for performing... | Centurion Medical Products, LP | OHG | |
| Z-2162-2019 | Class II | STERILE FLUORO SSP TRAY Kit Code: MNS11605 - Product Usage: This kit is used for... | Centurion Medical Products, LP | LRP | |
| Z-2161-2019 | Class II | STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:The speculum... | Centurion Medical Products, LP | HDF | |
| Z-2443-2019 | Class II | Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and... | CareFusion 303, Inc | CCK | |
| Z-2086-2019 | Class II | Rusch EasyCath Kit | Teleflex Medical | KOD | |
| Z-1986-2019 | Class III | Erisma- LP posterior fixation system with the below specifically affected products: 1... | Clariance, Inc. | NKB | |
| Z-2552-2019 | Class II | Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or... | Sentinel CH SpA | NDW | |
| Z-2551-2019 | Class II | MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using... | Sentinel CH SpA | NDW | |
| Z-2267-2019 | Class II | Smith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain PN: 02872 An... | Degania Silicone, Inc. | GBX | |
| Z-2266-2019 | Class II | Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An... | Degania Silicone, Inc. | GBX | |
| Z-2265-2019 | Class II | Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal... | Degania Silicone, Inc. | GBX | |
| Z-2264-2019 | Class II | Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar Cardinal... | Degania Silicone, Inc. | GBX | |
| Z-2263-2019 | Class II | Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes Cardinal Health... | Degania Silicone, Inc. | GBX | |
| Z-2262-2019 | Class II | Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar Product... | Degania Silicone, Inc. | GBX | |
| Z-2228-2019 | Class II | Workstation, G2, Configured (P/N 000-0241) | Intellijoint Surgical Inc. | OLO | |
| Z-2261-2019 | Class II | Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Health... | Degania Silicone, Inc. | GBX | |
| Z-2260-2019 | Class II | Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 An... | Degania Silicone, Inc. | GBX | |
| Z-2060-2019 | Class II | MAC VU360, Model Number 2030360-001, Electrocardiograph | GE Healthcare | DQK | |
| Z-0753-2020 | Class II | Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE... | Medicrea International | NKB | |
| Z-1596-2020 | Class II | Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554CM and MMT-754CM | Medtronic, Inc. | OYC | |
| Z-1595-2020 | Class II | Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554 and MMT-754 | Medtronic, Inc. | OYC | |
| Z-1594-2020 | Class II | Medtronic MiniMed Paradigm Insulin pump, model number MMT-723 | Medtronic, Inc. | OYC | |
| Z-0017-2020 | Class II | Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850 | Inter-Med, Inc. | KJJ | |
| Z-0016-2020 | Class II | Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 503825 | Inter-Med, Inc. | KJJ | |
| Z-0015-2020 | Class II | Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355 | Inter-Med, Inc. | KJJ | |
| Z-0014-2020 | Class II | Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF... | Inter-Med, Inc. | KJJ | |
| Z-0013-2020 | Class II | Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315 | Inter-Med, Inc. | KJJ | |
| Z-0012-2020 | Class II | Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300 | Inter-Med, Inc. | KJJ | |
| Z-1593-2020 | Class II | Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K | Medtronic, Inc. | OYC | |
| Z-1592-2020 | Class II | Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K | Medtronic, Inc. | OYC | |
| Z-1591-2020 | Class II | Medtronic MiniMed Paradigm Insulin pump, model number MMT-523 | Medtronic, Inc. | OYC | |
| Z-1590-2020 | Class II | Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K | Medtronic, Inc. | OYC |