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-2140-2023 | Class I | HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive... | Hamilton Medical AG | CBK | |
| Z-2139-2023 | Class I | HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure... | Hamilton Medical AG | CBK | |
| Z-2257-2023 | Class II | MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10... | Megadyne Medical Products, Inc | GEI | |
| Z-0020-2025 | Class II | IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and... | Philips North America LLC | MHX | |
| Z-2153-2023 | Class II | Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification... | DiaSorin Molecular LLC | OOI | |
| Z-2116-2023 | Class I | Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers... | Abiomed, Inc. | OZD | |
| Z-2115-2023 | Class I | Impella CP intravascular micro axial blood pump, Product Number 0048-0032 | Abiomed, Inc. | OZD | |
| Z-2114-2023 | Class I | Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers... | Abiomed, Inc. | OZD | |
| Z-2113-2023 | Class I | Impella LD intravascular micro axial blood pump, Product Number 005082 | Abiomed, Inc. | OZD | |
| Z-2112-2023 | Class I | Impella 5.0 intravascular micro axial blood pump, Product Number 005062 | Abiomed, Inc. | OZD | |
| Z-2111-2023 | Class I | Impella 2.5 intravascular micro axial blood pump, Product Number 005042 | Abiomed, Inc. | OZD | |
| Z-2362-2023 | Class II | Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3)... | Randox Laboratories, Limited | CDQ | |
| Z-2207-2023 | Class II | Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA... | Medtronic Neurosurgery | GXQ | |
| Z-2105-2023 | Class II | Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile. | Wright Medical Technology Inc | HSN | |
| Z-2400-2023 | Class II | MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR... | Philips North America LLC | LNH | |
| Z-2399-2023 | Class II | Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106 | Philips North America LLC | LNH | |
| Z-2398-2023 | Class II | Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and... | Philips North America LLC | LNH | |
| Z-2397-2023 | Class II | MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR... | Philips North America LLC | LNH | |
| Z-2396-2023 | Class II | Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106 | Philips North America LLC | LNH | |
| Z-2395-2023 | Class II | Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and... | Philips North America LLC | LNH | |
| Z-2284-2023 | Class II | Azurion 7 M20. X-ray Image guided Therapy System. | Philips Medical Systems Nederland B.V. | OWB | |
| Z-2283-2023 | Class II | Allura Xper FD10 and FD20. X-ray Imaging System. | Philips Medical Systems Nederland B.V. | OWB | |
| Z-2020-2023 | Class II | AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118 | TORNIER Inc. | KWS | |
| Z-2019-2023 | Class II | AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101 | TORNIER Inc. | KWS | |
| Z-2110-2023 | Class I | Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous... | Abbott Medical | DQY | |
| Z-2018-2023 | Class I | Oxylog 3000 Plus emergency and transport ventilator | Draeger, Inc. | CBK | |
| Z-2059-2023 | Class II | da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12 | Intuitive Surgical, Inc. | NAY | |
| Z-0777-2024 | Class II | REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE... | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urun | MUI | |
| Z-2239-2023 | Class II | Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter... | Argon Medical Devices, Inc | DTK | |
| Z-2413-2023 | Class II | HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for... | OLYMPUS Corporation of the Americas | FAS | |
| Z-2099-2023 | Class II | BD Synapsys Informatics Solution, Catalog Number 444150 | Becton Dickinson & Co | JQP | |
| Z-2017-2023 | Class I | Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190... | OLYMPUS Corporation of the Americas | EOQ | |
| Z-2016-2023 | Class I | Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180... | OLYMPUS Corporation of the Americas | EOQ | |
| Z-2015-2023 | Class I | Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170 | OLYMPUS Corporation of the Americas | EOQ | |
| Z-2014-2023 | Class I | Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160 | OLYMPUS Corporation of the Americas | EOQ | |
| Z-2013-2023 | Class I | Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150 | OLYMPUS Corporation of the Americas | EOQ | |
| Z-2012-2023 | Class I | Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2 | OLYMPUS Corporation of the Americas | EOQ | |
| Z-2011-2023 | Class I | Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60 | OLYMPUS Corporation of the Americas | EOQ | |
| Z-2577-2023 | Class II | BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a... | PTW-Freiburg | IYE | |
| Z-2238-2023 | Class II | FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA... | Terumo Cardiovascular Systems Corporation | OUT | |
| Z-1169-2025 | Class II | Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20... | Murata Vios, Inc. | DRT | |
| Z-0141-2025 | Class I | GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1)... | GE Healthcare | FMZ | |
| Z-0140-2025 | Class I | GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant... | GE Healthcare | FMZ | |
| Z-2280-2023 | Class II | NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and... | Hamamatsu Corp. | PSY | |
| Z-2123-2023 | Class II | Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage... | Medtronic Sofamor Danek USA Inc | OVD | |
| Z-2122-2023 | Class II | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF... | Medtronic Sofamor Danek USA Inc | OVD | |
| Z-2121-2023 | Class II | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF... | Medtronic Sofamor Danek USA Inc | OVD | |
| Z-2120-2023 | Class II | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF... | Medtronic Sofamor Danek USA Inc | OVD | |
| Z-2119-2023 | Class II | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF... | Medtronic Sofamor Danek USA Inc | OVD | |
| Z-2118-2023 | Class II | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF... | Medtronic Sofamor Danek USA Inc | OVD |