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-2132-2019 | Class II | GE Pristina Serena - Product Usage: Pristina Serena is an optional accessory of... | GE Healthcare | MUE | |
| Z-2131-2019 | Class II | GE Senographe Pristina - Product Usage: Senographe Pristina generates digital... | GE Healthcare | MUE | |
| Z-1911-2019 | Class II | Centricity PACS Foundation Centricity PACS software product is intended for the storage... | GE Healthcare | LLZ | |
| Z-1910-2019 | Class II | Centricity Universal Viewer 6.0 Is a device that displays medical images and data from... | GE Healthcare | LLZ | |
| Z-1838-2019 | Class III | Cepheid Xpert C. difficile/Epi Control Panel | Microbiologics, Inc. | PMN | |
| Z-1890-2019 | Class II | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C | Ethicon Endo-Surgery Inc | GEI | |
| Z-1889-2019 | Class II | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C | Ethicon Endo-Surgery Inc | GEI | |
| Z-1888-2019 | Class II | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C | Ethicon Endo-Surgery Inc | GEI | |
| Z-1774-2019 | Class II | InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product... | Medtronic Neuromodulation | EZW | |
| Z-1705-2019 | Class I | IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm)... | Edwards Lifesciences LLC | DXC | |
| Z-0061-2020 | Class II | BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic... | Becton Dickinson & Co | JKA | |
| Z-0060-2020 | Class II | BD Microtainer PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog Number: 365987 | Becton Dickinson & Co | JKA | |
| Z-0059-2020 | Class II | BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985 | Becton Dickinson & Co | JKA | |
| Z-0058-2020 | Class II | BD Microtainer SST- Amber Part/Catalog Number: 365978 | Becton Dickinson & Co | JKA | |
| Z-0057-2020 | Class II | BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974 | Becton Dickinson & Co | JKA | |
| Z-0056-2020 | Class II | BD Microtainer SST Part/Catalog No.365967 | Becton Dickinson & Co | JKA | |
| Z-0055-2020 | Class II | BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965 | Becton Dickinson & Co | JKA | |
| Z-0054-2020 | Class II | BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963 | Becton Dickinson & Co | JKA | |
| Z-0365-2020 | Class II | Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339... | Cadence Inc. | FMF | |
| Z-1912-2019 | Class I | Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and... | Teleflex Medical | BZE | |
| Z-1907-2019 | Class II | EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the... | Phadia AB | DHR | |
| Z-2067-2019 | Class I | Centurion Convenience Kits, containing BD Alaris Pump Infusion Sets. BD code 11522558... | MEDLINE INDUSTRIES, LP - Northfield | N/A | |
| Z-1879-2019 | Class III | Replacement ECG leadwires with snap ends REF/Catalog Number Description 2106386-101 Replac... | GE Healthcare | DSA | |
| Z-1878-2019 | Class III | Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG Leadwire... | GE Healthcare | DSA | |
| Z-1877-2019 | Class III | Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replac... | GE Healthcare | DSA | |
| Z-1876-2019 | Class III | ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire set, 5-lead... | GE Healthcare | DSA | |
| Z-1875-2019 | Class III | ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable, 3/5-lead... | GE Healthcare | DSA | |
| Z-1773-2019 | Class III | CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF... | Cardiocommand Inc. | LPA | |
| Z-0173-2020 | Class II | Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument... | Abbott Medical | GKZ | |
| Z-1718-2019 | Class II | Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The... | I.T.S. GmbH | HRS | |
| Z-1925-2019 | Class II | First Step Draco Pad, Product Number EP-4D | Madison Polymeric Engineering | MNL | |
| Z-1924-2019 | Class II | Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product Number... | Madison Polymeric Engineering | MNL | |
| Z-2133-2019 | Class II | Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The... | Invivo Corporation | DQA | |
| Z-1891-2019 | Class II | RNeasy DSP FFPE Kit (48), REF 73604 - Product Usage: The RNeasy DSP FFPE Kit is a system... | Qiagen | NTW | |
| Z-1691-2019 | Class II | Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray... | Samsung HME America, Inc. | IZL | |
| Z-1734-2019 | Class II | GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part... | Maquet Cardiovascular Us Sales, LLC | LGX | |
| Z-1770-2019 | Class I | Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414... | Becton Dickinson & Co | FPA | |
| Z-1526-2020 | Class II | OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product... | Xtant Medical Holdings, Inc. | MBP | |
| Z-2753-2019 | Class II | Accu-Chek Connect Diabetes Management App | Roche Diabetes Care, Inc. | NDC | |
| Z-1914-2019 | Class II | Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number... | Siemens Healthcare Diagnostics Inc. | CGS | |
| Z-1913-2019 | Class II | ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number... | Siemens Healthcare Diagnostics Inc. | CGS | |
| Z-2066-2019 | Class I | Medline Primary Warmer Pack, Product No. DYNJ52510A. The Medline Primary Warmer Pack... | MEDLINE INDUSTRIES, LP - Northfield | N/A | |
| Z-1786-2019 | Class II | Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and... | Monarch Medical Technologies | NDC | |
| Z-1850-2019 | Class II | Aution Hybrid Au-4050 | Arkray Factory USA, Inc. | KQO | |
| Z-1729-2019 | Class II | Leica Cryostats, used to produce frozen sample sections for biological, medical and... | Leica Microsystems, Inc. | IDP | |
| Z-2214-2019 | Class II | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton... | Bard Peripheral Vascular Inc | KNW | |
| Z-2213-2019 | Class II | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton... | Bard Peripheral Vascular Inc | KNW | |
| Z-2212-2019 | Class II | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton... | Bard Peripheral Vascular Inc | KNW | |
| Z-2211-2019 | Class II | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton... | Bard Peripheral Vascular Inc | KNW | |
| Z-2210-2019 | Class II | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton... | Bard Peripheral Vascular Inc | KNW |