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-1328-2023 | Class II | Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF... | Medtronic Sofamor Danek USA Inc | MBP | |
| Z-1327-2023 | Class II | Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF... | Medtronic Sofamor Danek USA Inc | MBP | |
| Z-1326-2023 | Class II | Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF... | Medtronic Sofamor Danek USA Inc | MBP | |
| Z-1325-2023 | Class II | Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090; b) DBM... | Medtronic Sofamor Danek USA Inc | MBP | |
| Z-1324-2023 | Class II | Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115... | Medtronic Sofamor Danek USA Inc | MBP | |
| Z-1323-2023 | Class II | Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102... | Medtronic Sofamor Danek USA Inc | MBP | |
| Z-1478-2023 | Class II | injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in... | Abbott Medical | FBK | |
| Z-1191-2023 | Class II | stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external... | Stryker Corp. | KTT | |
| Z-1230-2023 | Class II | Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75... | Datascope Corp. | DSP | |
| Z-1229-2023 | Class II | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31... | Datascope Corp. | DSP | |
| Z-1232-2023 | Class II | Cardiosave Rescue. Model Number: 0998-00-0800-83. | Datascope Corp. | DSP | |
| Z-1231-2023 | Class II | Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31... | Datascope Corp. | DSP | |
| Z-1221-2023 | Class II | CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The... | Abbott Medical | MOM | |
| Z-1220-2023 | Class II | CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, The... | Abbott Medical | MOM | |
| Z-1219-2023 | Class II | CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The... | Abbott Medical | MOM | |
| Z-1218-2023 | Class II | CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The... | Abbott Medical | MOM | |
| Z-1225-2023 | Class II | CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS... | Abbott Medical | MOM | |
| Z-1224-2023 | Class II | CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS... | Abbott Medical | MOM | |
| Z-1223-2023 | Class II | CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS... | Abbott Medical | MOM | |
| Z-1148-2023 | Class I | Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85 | Datascope Corp. | DSP | |
| Z-1147-2023 | Class I | Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800... | Datascope Corp. | DSP | |
| Z-1146-2023 | Class I | Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part... | Datascope Corp. | DSP | |
| Z-1145-2023 | Class I | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part... | Datascope Corp. | DSP | |
| Z-1284-2023 | Class II | G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number... | Zimmer GmbH | LPH | |
| Z-1203-2023 | Class II | Phoenix mKDR Xpress, digital mobile diagnostic x-ray system | Sedecal S.A. | IZL | |
| Z-1202-2023 | Class II | Phoenix mKDR, digital mobile diagnostic x-ray system | Sedecal S.A. | IZL | |
| Z-1250-2023 | Class II | Arial mobile application, model #54630 and #54640 for Android devices downloaded from the... | Securitas Healthcare LLC | IQA | |
| Z-1201-2023 | Class II | MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects... | bioMerieux, Inc. | OUG | |
| Z-1307-2023 | Class II | ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the... | Instrumentation Laboratory Co. | KFF | |
| Z-1306-2023 | Class II | ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis... | Instrumentation Laboratory Co. | KFF | |
| Z-1305-2023 | Class II | ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis... | Instrumentation Laboratory Co. | KFF | |
| Z-1304-2023 | Class II | ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory... | Instrumentation Laboratory Co. | KFF | |
| Z-1406-2023 | Class II | Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251 | Halyard Health | KXF | |
| Z-1205-2023 | Class II | Sit to Stand STS500 Patient Lift | Med-Mizer, Inc. | FSA | |
| Z-1204-2023 | Class II | Med-Riser MR600 Patient Lift | Med-Mizer, Inc. | FSA | |
| Z-1190-2023 | Class I | BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold. | Halyard Health | BSY | |
| Z-1189-2023 | Class I | BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold. | Halyard Health | BSY | |
| Z-0479-2026 | Class II | BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000; | Miach Orthopaedics | QNI | |
| Z-1498-2023 | Class II | ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-1397-2023 | Class II | Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF)... | Boston Scientific Corporation | KNS | |
| Z-1311-2023 | Class II | ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-1170-2023 | Class II | ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device | Wright Medical Technology Inc | HRS | |
| Z-1169-2023 | Class II | ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device | Wright Medical Technology Inc | HRS | |
| Z-1216-2023 | Class II | LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model... | Boston Scientific Corporation | LWS | |
| Z-1308-2023 | Class II | MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor... | Ortho-Clinical Diagnostics, Inc. | DBA | |
| Z-1286-2023 | Class II | CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of... | Randox Laboratories, Limited | DCK | |
| Z-1256-2023 | Class II | Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency... | Stryker Medical | FPO | |
| Z-1248-2023 | Class II | TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for... | Synthes (USA) Products LLC | HSB | |
| Z-1247-2023 | Class II | TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for... | Synthes (USA) Products LLC | HSB | |
| Z-1246-2023 | Class II | TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for... | Synthes (USA) Products LLC | HSB |