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-1453-2022 | Class II | Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht... | NuVasive Inc | MJO | |
| Z-1397-2022 | Class I | Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for... | Bard Access Systems, Inc. | FMI | |
| Z-1497-2022 | Class II | Merlin.net model MN5000 Software | Abbott Medical | DXY | |
| Z-1496-2022 | Class II | Merlin 2 PCS MER37000 programmer Model MER3400 software | Abbott Medical | DXY | |
| Z-1495-2022 | Class II | Merlin PCS 3650 programmer Model 3330 software | Abbott Medical | DXY | |
| Z-1335-2022 | Class II | VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23 | Luminex Corporation | PCH | |
| Z-1334-2022 | Class II | Verigene CDF Nucleic Acid Test, Part No. 30-002-22 | Luminex Corporation | OZN | |
| Z-1705-2022 | Class II | Various eye packs, cataract packs | American Contract Systems, Inc. | OJK | |
| Z-1704-2022 | Class II | D&C pack | American Contract Systems, Inc. | PKF | |
| Z-1703-2022 | Class II | Various C-section packs | American Contract Systems, Inc. | OHM | |
| Z-1702-2022 | Class II | Various hysterectomy, vaginal packs | American Contract Systems, Inc. | OHD | |
| Z-1701-2022 | Class II | Various ob/gyn packs | American Contract Systems, Inc. | MLS | |
| Z-1700-2022 | Class II | Various neurology packs | American Contract Systems, Inc. | OJG | |
| Z-1699-2022 | Class II | Various convenience packs | American Contract Systems, Inc. | OJH | |
| Z-1698-2022 | Class II | Various convenience packs | American Contract Systems, Inc. | LRO | |
| Z-1697-2022 | Class II | Breast Abdominoplasty Pack | American Contract Systems, Inc. | FTN | |
| Z-1696-2022 | Class II | Various Port Insertion Packs | American Contract Systems, Inc. | OKE | |
| Z-1695-2022 | Class II | Various Cysto Packs | American Contract Systems, Inc. | NWU | |
| Z-1694-2022 | Class II | Various Laparoscopy Packs | American Contract Systems, Inc. | FDE | |
| Z-1693-2022 | Class II | Various ENT Packs | American Contract Systems, Inc. | OGR | |
| Z-1692-2022 | Class II | Various PICC Line, Central Line Packs | American Contract Systems, Inc. | OFF | |
| Z-1691-2022 | Class II | Various Pacemaker Packs, Cardio Thoracic Packs | American Contract Systems, Inc. | OEZ | |
| Z-1690-2022 | Class II | Various Angiography/Cath Lab packs/trays | American Contract Systems, Inc. | OES | |
| Z-1689-2022 | Class II | Various Angiography packs/trays | American Contract Systems, Inc. | OEQ | |
| Z-1464-2022 | Class II | AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number... | Fresenius Medical Care Renal Therapies Group, LLC | FIP | |
| Z-1463-2022 | Class II | AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number... | Fresenius Medical Care Renal Therapies Group, LLC | FIP | |
| Z-1462-2022 | Class II | nordicBrainEX, software versions 2.21 through 2.3.10 | NordicNeuroLab AS | LLZ | |
| Z-1426-2022 | Class II | Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool... | Siemens Medical Solutions USA, Inc. | DQK | |
| Z-1425-2022 | Class II | Sensis with software version VD12A. A diagnostic and administrative tool supporting... | Siemens Medical Solutions USA, Inc. | DQK | |
| Z-1452-2022 | Class II | SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090... | Stryker Corp. | LWH | |
| Z-1401-2022 | Class I | SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test... | North American Diagnostics | QKP | |
| Z-1469-2022 | Class II | Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1 | Sight Diagnostics, Ltd. | GKZ | |
| Z-1466-2022 | Class II | Centricity PACS Software Version 7.0 SP0.0.4.7 | GE Healthcare | LLZ | |
| Z-1390-2022 | Class III | Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for... | R & D Systems, Inc. | GGT | |
| Z-1366-2022 | Class II | Wright EVOLVE TRIAD Plate Cutter, REF 49510120 | Wright Medical Technology Inc | QLR | |
| Z-1421-2022 | Class II | LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055 | CooperSurgical, Inc. | MQL | |
| Z-1307-2022 | Class II | Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and... | K2M, Inc | KWP | |
| Z-1294-2022 | Class II | Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000 | Siemens Medical Solutions USA, Inc. | JAA | |
| Z-1299-2022 | Class II | RayStation 11B | RaySearch Laboratories AB (publ) | MUJ | |
| Z-1507-2022 | Class II | Haiou Needle Retractable Safety Syringe with Needle-1ML 23G x 1 (0.6x25mm)... | Guangdong Haiou Medical Apparatus Co., Ltd. | MEG | |
| Z-1506-2022 | Class II | HAIOU Needle retractable safety syringe with needle-(1ml syringe with 25G x 1-inch... | Guangdong Haiou Medical Apparatus Co., Ltd. | MEG | |
| Z-1369-2022 | Class III | Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada... | Invacare GmbH | CAW | |
| Z-1456-2022 | Class II | REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3... | Abbott Medical | PDJ | |
| Z-1455-2022 | Class II | REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3... | Abbott Medical | PDJ | |
| Z-1454-2022 | Class II | REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL... | Abbott Medical | PDJ | |
| Z-1423-2022 | Class III | Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD | Randox Laboratories, Limited | DDG | |
| Z-1422-2022 | Class III | Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD | Randox Laboratories, Limited | DDG | |
| Z-1373-2022 | Class II | Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO... | Alcon Laboratories | LRO | |
| Z-1344-2022 | Class II | Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF... | Abbott Medical | OAE | |
| Z-1350-2022 | Class II | CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000 | Zeltiq Aesthetics Inc | OOK |