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-1235-2020 | Class II | Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog... | Medtronic, Inc. | LRO | |
| Z-1301-2020 | Class II | Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog... | Medtronic, Inc. | LRO | |
| Z-1341-2020 | Class II | UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is... | FUJIFILM Healthcare Americas Corporation | ITX | |
| Z-1525-2020 | Class II | Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program Medtronic... | Medtronic, Inc. | OSR | |
| Z-1524-2020 | Class II | Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and... | Medtronic, Inc. | OSR | |
| Z-1437-2020 | Class II | LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product... | Organ Recovery Systems, Inc. | KDN | |
| Z-0440-2021 | Class II | Class IV New Era medical laser device | Inova Lasers LLC | GEX | |
| Z-2136-2020 | Class II | ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product... | Siemens Healthcare Diagnostics Inc. | JFL | |
| Z-1529-2020 | Class II | Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T... | Fresenius Medical Care Renal Therapies Group, LLC | KDI | |
| Z-1144-2020 | Class I | NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler RX 4.5 X... | Abbott Vascular | LOX | |
| Z-1143-2020 | Class I | NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 X... | Abbott Vascular | LOX | |
| Z-1142-2020 | Class I | NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler RX 4.0 X... | Abbott Vascular | LOX | |
| Z-1141-2020 | Class I | NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler RX 4.0 X... | Abbott Vascular | LOX | |
| Z-1140-2020 | Class I | NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler RX 4.0 X... | Abbott Vascular | LOX | |
| Z-1139-2020 | Class I | NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 X 20MM... | Abbott Vascular | LOX | |
| Z-1138-2020 | Class I | NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 X 15MM BDC... | Abbott Vascular | LOX | |
| Z-1137-2020 | Class I | NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00 X 12MM... | Abbott Vascular | LOX | |
| Z-1136-2020 | Class I | NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC... | Abbott Vascular | LOX | |
| Z-1135-2020 | Class I | NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50 X 20MM... | Abbott Vascular | LOX | |
| Z-1134-2020 | Class I | NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 X 15MM... | Abbott Vascular | LOX | |
| Z-1133-2020 | Class I | NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM... | Abbott Vascular | LOX | |
| Z-1132-2020 | Class I | NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC... | Abbott Vascular | LOX | |
| Z-1131-2020 | Class I | NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00 X 20MM... | Abbott Vascular | LOX | |
| Z-1130-2020 | Class I | NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 X 15MM... | Abbott Vascular | LOX | |
| Z-1129-2020 | Class I | NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM... | Abbott Vascular | LOX | |
| Z-1128-2020 | Class I | NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00 X 8MM BDC... | Abbott Vascular | LOX | |
| Z-2133-2020 | Class II | JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The... | Smith & Nephew, Inc. | HSX | |
| Z-2132-2020 | Class II | JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The... | Smith & Nephew, Inc. | HSX | |
| Z-1473-2020 | Class II | Iliac Screws, multiple sizes, Article Nos. B36020500 B36020570 B36020580 B36020590 B36027... | Medicrea International | KWP | |
| Z-1476-2020 | Class II | QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid... | Qiagen | OOI | |
| Z-1472-2020 | Class II | Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B360... | Medicrea International | KWP | |
| Z-1352-2020 | Class II | Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory... | Breas Medical AB | NOU | |
| Z-1408-2020 | Class II | McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope... | Medtronic, Inc. | CCW | |
| Z-1364-2020 | Class II | Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a... | Exactech, Inc. | JWH | |
| Z-1103-2020 | Class II | fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at... | FridaBaby LLC | EFW | |
| Z-1340-2020 | Class II | ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-1580-2020 | Class II | LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i... | Abbott Medical | JJE | |
| Z-1793-2020 | Class II | PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units)... | bioMerieux, Inc. | ||
| Z-2497-2020 | Class II | DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer... | Ra Medical Systems,Inc | PDU | |
| Z-1428-2020 | Class I | HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated... | HeartWare, Inc. | DSQ | |
| Z-1427-2020 | Class I | HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for... | HeartWare, Inc. | DSQ | |
| Z-1402-2022 | Class II | Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019... | Stryker Corp. | PBZ | |
| Z-2296-2020 | Class II | FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 00815381020093 used with... | BioFire Diagnostics, LLC | PEN | |
| Z-2295-2020 | Class II | FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used... | BioFire Diagnostics, LLC | PEN | |
| Z-1460-2020 | Class II | Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan... | Braemar Manufacturing, LLC | MWJ | |
| Z-1459-2020 | Class II | Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan... | Braemar Manufacturing, LLC | MWJ | |
| Z-1351-2020 | Class II | Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC... | Abbott Medical | NVZ | |
| Z-1358-2020 | Class II | Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN... | MEDLINE INDUSTRIES, LP - Northfield | FDE | |
| Z-1357-2020 | Class II | Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN... | MEDLINE INDUSTRIES, LP - Northfield | OJH | |
| Z-1343-2020 | Class II | Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry... | Hologic, Inc. | MUE |