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-0770-2023 | Class II | Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak... | Acumed LLC | HWC | |
| Z-0769-2023 | Class II | AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist... | Acumed LLC | HWC | |
| Z-0768-2023 | Class II | Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2 - 5.5... | Acumed LLC | HWC | |
| Z-0767-2023 | Class II | Part Number/Part Description: 30-0033-S 30mm Acutrak Fusion Device 6mm... | Acumed LLC | HWC | |
| Z-0929-2023 | Class I | Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit... | Universal Meditech Inc. | QKP | |
| Z-0906-2023 | Class II | DeRoyal Tonsillectomy Tray, REF 89-10698.01 | DeRoyal Industries, Inc. | LRO | |
| Z-0773-2023 | Class I | RSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229. Used to remove... | Serb Medical Solutions Inc. | MAC | |
| Z-0958-2023 | Class III | Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT... | Abbott Medical | DHA | |
| Z-1481-2023 | Class II | LUMINOS Lotus Max (VF11) | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-1480-2023 | Class II | Luminos dRF Max (VE10, VF10, VF11) | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-1479-2023 | Class II | Luminos Agile Max (VE10, VF10, VF11) | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0955-2023 | Class II | COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation... | Medtronic, Inc. | NEY | |
| Z-0764-2023 | Class II | Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by... | Baxter Healthcare Corporation | KDI | |
| Z-0763-2023 | Class II | Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by... | Baxter Healthcare Corporation | KDI | |
| Z-0762-2023 | Class II | Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by... | Baxter Healthcare Corporation | KDI | |
| Z-0761-2023 | Class II | Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to... | Baxter Healthcare Corporation | KDI | |
| Z-0760-2023 | Class II | Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal... | Baxter Healthcare Corporation | KDI | |
| Z-0905-2023 | Class II | Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality... | Randox Laboratories, Limited | JJY | |
| Z-0904-2023 | Class II | Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality... | Randox Laboratories, Limited | JJY | |
| Z-0903-2023 | Class II | Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum... | Randox Laboratories, Limited | JJY | |
| Z-0740-2023 | Class II | Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090 | Abbott Molecular, Inc. | QJR | |
| Z-0739-2023 | Class II | Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096 | Abbott Molecular, Inc. | QJR | |
| Z-0463-2023 | Class II | Philips Upgrade to MR 7700 System, Model Number 782130 | Philips North America LLC | LNH | |
| Z-0462-2023 | Class II | Philips MR 7700 System, Model Number 782120 | Philips North America LLC | LNH | |
| Z-0461-2023 | Class II | Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144 | Philips North America LLC | LNH | |
| Z-0460-2023 | Class II | Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136 | Philips North America LLC | LNH | |
| Z-0459-2023 | Class II | Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137 | Philips North America LLC | LNH | |
| Z-0776-2023 | Class II | Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4... | Medtronic, Inc. | MDS | |
| Z-0908-2023 | Class II | Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate... | Philips North America LLC | HGP | |
| Z-0477-2023 | Class II | Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system | Leica Microsystems, Inc. | EPT | |
| Z-0476-2023 | Class II | Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard)... | Leica Microsystems, Inc. | EPT | |
| Z-0475-2023 | Class II | Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system | Leica Microsystems, Inc. | HRM | |
| Z-0473-2023 | Class II | BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria... | Becton Dickinson & Co | JTY | |
| Z-1676-2023 | Class II | The 4Kscore Test is an in vitro serum or plasma test that combines the results of four... | BioReference Health, LLC | QRF | |
| Z-1159-2023 | Class II | Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553E | Medtronic, Inc. | LRS | |
| Z-1158-2023 | Class II | Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #... | Medtronic, Inc. | LRS | |
| Z-1157-2023 | Class II | Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #... | Medtronic, Inc. | LRS | |
| Z-0930-2023 | Class II | Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number. a... | MEDLINE INDUSTRIES, LP - Northfield | GFA | |
| Z-0907-2023 | Class II | VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD)... | Ventana Medical Systems Inc | PLS | |
| Z-0735-2023 | Class II | The Natus Cranial Access Kit is designed to be a complete, single use and disposable... | Natus Medical Incorporated | PSP | |
| Z-0344-2023 | Class II | MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT)... | Brainlab, Inc. | JAK | |
| Z-0777-2023 | Class II | BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only. | Siemens Healthcare Diagnostics Inc. | JJW | |
| Z-0474-2023 | Class II | Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator... | ConMed Corporation | GEI | |
| Z-0724-2023 | Class II | DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q | Sunrise Medical, Inc. | CAW | |
| Z-1473-2023 | Class II | OttLite Rechargeable UVC Disinfecting Wand | Ottlite TEchnologies, Inc. | RHP | |
| Z-1097-2023 | Class II | Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY... | MEDLINE INDUSTRIES, LP - Northfield | OII | |
| Z-1096-2023 | Class II | Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS c. TOTAL... | MEDLINE INDUSTRIES, LP - Northfield | OJH | |
| Z-1095-2023 | Class II | Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF b. VITRECTOMY... | MEDLINE INDUSTRIES, LP - Northfield | OJK | |
| Z-1094-2023 | Class II | Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC... | MEDLINE INDUSTRIES, LP - Northfield | OKV | |
| Z-1093-2023 | Class II | Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH... | MEDLINE INDUSTRIES, LP - Northfield | OJF |