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-0482-2019 | Class II | Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda... | GE Healthcare | FMT | |
| Z-0481-2019 | Class II | Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe... | GE Healthcare | FMT | |
| Z-0480-2019 | Class II | Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following... | GE Healthcare | FMZ | |
| Z-0479-2019 | Class II | Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product... | GE Healthcare | FMZ | |
| Z-1893-2019 | Class II | Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc... | Advanced Medical Optics, Inc. | MLZ | |
| Z-0513-2019 | Class II | PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software... | PerkinElmer Health Sciences Canada, Inc. | DOP | |
| Z-0301-2019 | Class II | Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The... | Roche Diagnostics GmbH | KHE | |
| Z-0313-2019 | Class II | BD Max Instrument, Catalog Number 441916 441927 (refurbished instrument) - Product Usage... | Becton Dickinson & Co | PQA | |
| Z-0312-2019 | Class II | BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired... | Becton Dickinson & Co | PQA | |
| Z-0462-2019 | Class II | Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388 | Invivo Corporation | DQK | |
| Z-0008-2020 | Class II | ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 250... | The Metrix Company | KPE | |
| Z-0007-2020 | Class II | ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500... | The Metrix Company | KPE | |
| Z-0006-2020 | Class II | SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL, REF 66641 (Canadian... | The Metrix Company | KPE | |
| Z-0005-2020 | Class II | SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian... | The Metrix Company | KPE | |
| Z-0004-2020 | Class II | SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian... | The Metrix Company | KPE | |
| Z-0003-2020 | Class II | SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640... | The Metrix Company | KPE | |
| Z-0002-2020 | Class II | SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630... | The Metrix Company | KPE | |
| Z-0001-2020 | Class II | SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615... | The Metrix Company | KPE | |
| Z-1123-2019 | Class II | Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R... | Encore Medical, LP | KWZ | |
| Z-1129-2019 | Class II | CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected... | Depuy Orthopaedics Inc. | LXH | |
| Z-1128-2019 | Class II | CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 Product Usage: The affected... | Depuy Orthopaedics Inc. | LXH | |
| Z-1127-2019 | Class II | CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Usage: The... | Depuy Orthopaedics Inc. | LXH | |
| Z-0294-2019 | Class II | RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-0468-2019 | Class II | Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-0399-2019 | Class II | StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer... | Zimmer GmbH | KWY | |
| Z-0081-2019 | Class III | BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398... | Becton Dickinson & Co | MNM | |
| Z-0237-2019 | Class II | Single-Use Biopsy Forceps, JUMBO ALLIGATOR,3.2mm, REF Catalog No. NBF13-01130230, UPN... | Micro-Tech (Nanjing) Co., Ltd. | GEN | |
| Z-0118-2019 | Class II | AS-OBGYN Information System version 7.824.x | As Software, LLC | LLZ | |
| Z-0100-2019 | Class I | Cardiosave Rescue IABP, Part Number 0998-UC-0800-83 | Datascope Corp. | DSP | |
| Z-0099-2019 | Class I | Cardiosave Hybrid IABP, Part Number 0998-00-0800-53 | Datascope Corp. | DSP | |
| Z-2090-2019 | Class II | Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore... | Encore Medical, LP | HWE | |
| Z-0239-2019 | Class II | Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models... | Philips Medical Systems DMC GmbH | MQB | |
| Z-2763-2019 | Class II | The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic... | Siemens Healthcare Diagnostics Inc. | CGR | |
| Z-0497-2019 | Class I | Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult... | Medtronic, Inc. | CBK | |
| Z-0107-2019 | Class II | Spectrum Iq Infusion System with Dose Iq Safety Software, 3570009 | Baxter Healthcare Corporation | PHC | |
| Z-0200-2019 | Class II | Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411... | Smith & Nephew, Inc. | MBH | |
| Z-1982-2019 | Class II | Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the... | Siemens Healthcare Diagnostics Inc. | JQP | |
| Z-0404-2019 | Class II | Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray... | Medtronic Navigation, Inc | OWB | |
| Z-0218-2019 | Class II | NucliSENS Magnetic Extraction Reagents | bioMerieux, Inc. | PPM | |
| Z-0281-2019 | Class II | BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III... | Leica Microsystems, Inc. | KPA | |
| Z-0090-2019 | Class II | Reprocessed Agilis Steerable Introducer: indicated for introducing various... | Sterilmed Inc | PNH | |
| Z-1099-2019 | Class II | SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin... | LivaNova USA, Inc. | DWC | |
| Z-0371-2019 | Class I | GE Healthcare Millennium MC | GE Healthcare | KPS | |
| Z-0370-2019 | Class I | GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL... | GE Healthcare | KPS | |
| Z-0369-2019 | Class I | GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition... | GE Healthcare | KPS | |
| Z-0234-2019 | Class II | Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx... | Microtek Medical LLC | PUI | |
| Z-0233-2019 | Class II | Disposable Accessory Kit, 3-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx... | Microtek Medical LLC | PUI | |
| Z-0232-2019 | Class II | Camera Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to... | Microtek Medical LLC | PUI | |
| Z-0231-2019 | Class II | Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile /... | Microtek Medical LLC | PUI | |
| Z-0445-2019 | Class II | VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers)... | Luminex Corporation | PAM |