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-0676-2020 | Class II | MRIdian Linac Radiation Therapy System Model 10000 and 20000 | Viewray, Inc. | IYE | |
| Z-1203-2019 | Class II | Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional... | Abbott Medical | DSQ | |
| Z-1091-2019 | Class II | Integra bioBLOCK Resorbable subtaler Implant, 12mm Catalog Number: 040012 - Product... | Integra Lifesciences Sales LLC | HWC | |
| Z-1090-2019 | Class II | Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - Product... | Integra Lifesciences Sales LLC | HWC | |
| Z-1089-2019 | Class II | Integra bioBLOCK Resorbable subtaler Implant, 10mm Catalog Number: 40010 - Product Usage... | Integra Lifesciences Sales LLC | HWC | |
| Z-1087-2019 | Class II | Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Titanium... | Zimmer GmbH | JWH | |
| Z-1086-2019 | Class II | Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium... | Zimmer GmbH | JWH | |
| Z-1710-2019 | Class II | BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the... | Becton Dickinson & Co | FOZ | |
| Z-1068-2019 | Class II | Laparotomy Sponge with the following product description and model numbers: 1. Lap... | Medical Action Industries, Inc. 306 | GDY | |
| Z-1081-2019 | Class II | Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation... | Zimmer GmbH | KIH | |
| Z-1056-2019 | Class II | URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips... | Philips North America LLC | OWB | |
| Z-1055-2019 | Class II | MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product... | Philips North America LLC | KPR | |
| Z-1054-2019 | Class II | Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product Usage: The... | Philips North America LLC | JAA | |
| Z-1053-2019 | Class II | Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MRF can be used... | Philips North America LLC | IXR | |
| Z-1052-2019 | Class II | MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I... | Philips North America LLC | IZI | |
| Z-1210-2019 | Class I | SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696 | Becton Dickinson & Co | FPA | |
| Z-2054-2019 | Class II | MOOG Curlin Infusion Administration Set, REF 340-4130-V, Non-DEHP Tubing with Non-Vented... | Zevex, Inc. | FRN | |
| Z-2053-2019 | Class II | MOOG Curlin Infusion Administration Set, REF 340-4130, Non-DEHP Tubing with Non-Vented... | Zevex, Inc. | FRN | |
| Z-1080-2019 | Class III | McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers... | Cypress Medical Products LLC | KHE | |
| Z-0797-2020 | Class III | Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M | Teleflex Medical | NNY | |
| Z-0796-2020 | Class III | Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500 | Teleflex Medical | NNY | |
| Z-1082-2019 | Class I | Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine &... | Brainlab, Inc. | HAW | |
| Z-1197-2019 | Class II | Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c processing... | Abbott Medical | JJE | |
| Z-1196-2019 | Class II | Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing... | Abbott Medical | JJE | |
| Z-2144-2019 | Class II | CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number ILDAT3 - Product... | ZimVie US Corp LLC | NHA | |
| Z-2143-2019 | Class II | CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3 - Product Usage: BIOMET3i... | ZimVie US Corp LLC | NHA | |
| Z-2142-2019 | Class II | CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IIAT3 - Product Usage... | ZimVie US Corp LLC | NHA | |
| Z-2141-2019 | Class II | CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage... | ZimVie US Corp LLC | NHA | |
| Z-2140-2019 | Class II | CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i... | ZimVie US Corp LLC | NHA | |
| Z-0771-2020 | Class III | NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact... | Nidek Incorporated | NQE | |
| Z-1026-2019 | Class III | Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog... | Cook Medical LLC | DTK | |
| Z-1025-2019 | Class III | Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Catalog Number... | Cook Medical LLC | DTK | |
| Z-1024-2019 | Class III | Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog Number... | Cook Medical LLC | DTK | |
| Z-1023-2019 | Class III | Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number... | Cook Medical LLC | DTK | |
| Z-1022-2019 | Class III | Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Catalog Number... | Cook Medical LLC | DTK | |
| Z-1021-2019 | Class III | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number... | Cook Medical LLC | DTK | |
| Z-1767-2019 | Class II | xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection... | Luminex Molecular Diagnostics Inc | PCH | |
| Z-1064-2019 | Class II | Paltop 1.25 Hex Drivers, Short Part Number: 60-70102 | Keystone Dental Inc. | DZE | |
| Z-1063-2019 | Class II | Paltop 1.25 Hex Drivers, Long Part Number: 60-70101 | Keystone Dental Inc. | DZE | |
| Z-1062-2019 | Class II | Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical and... | Keystone Dental Inc. | DZE | |
| Z-1061-2019 | Class II | Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative... | Keystone Dental Inc. | DZE | |
| Z-1060-2019 | Class III | Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ECG TRUNK... | GE Healthcare | IKD | |
| Z-3000-2020 | Class II | Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI... | ArthroCare Corporation | GAT | |
| Z-1098-2019 | Class I | SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administration... | Abbott Medical | FPA | |
| Z-1097-2019 | Class I | icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF... | Abbott Medical | FPA | |
| Z-1096-2019 | Class I | icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). Used in IV... | Abbott Medical | FPA | |
| Z-1095-2019 | Class I | icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated... | Abbott Medical | FPA | |
| Z-1094-2019 | Class I | icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter... | Abbott Medical | FPA | |
| Z-1093-2019 | Class I | icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administration... | Abbott Medical | FPA | |
| Z-1092-2019 | Class I | icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration... | Abbott Medical | FPA |