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-0878-2019 | Class II | Intera 1.5T Power/Pulsar, Model Number 781105. Nuclear Magnetic Resonance Imaging System | Philips Medical Systems Nederland B.V. | LNH | |
| Z-0877-2019 | Class II | Intera 1.5T Omni/Stellar, Model Number 781104. Nuclear Magnetic Resonance Imaging System | Philips Medical Systems Nederland B.V. | LNH | |
| Z-0876-2019 | Class II | Intera 1.0T Power/Pulsar, Model Number 781103. Nuclear Magnetic Resonance Imaging System | Philips Medical Systems Nederland B.V. | LNH | |
| Z-0875-2019 | Class II | Intera 1.0T Omni/Stellar, Model Number 781102. Nuclear Magnetic Resonance Imaging System | Philips Medical Systems Nederland B.V. | LNH | |
| Z-0874-2019 | Class II | Intera 0.5T Standard, Model Number 781101. Nuclear Magnetic Resonance Imaging System | Philips Medical Systems Nederland B.V. | LNH | |
| Z-0873-2019 | Class II | Multiva 1.5T 16 R5, Model Number 781078. Nuclear Magnetic Resonance Imaging System | Philips Medical Systems Nederland B.V. | LNH | |
| Z-0872-2019 | Class II | Multiva 1.5T 16 R5 (ZBO), Model Number 781073. Nuclear Magnetic Resonance Imaging System | Philips Medical Systems Nederland B.V. | LNH | |
| Z-0871-2019 | Class II | Multiva 1.5T 8 R5 (ZBO), Model Number 781072. Nuclear Magnetic Resonance Imaging System | Philips Medical Systems Nederland B.V. | LNH | |
| Z-0870-2019 | Class II | Prodiva CX, Model Number 781070. Nuclear Magnetic Resonance Imaging System | Philips Medical Systems Nederland B.V. | LNH | |
| Z-0869-2019 | Class II | Prodiva CS, Model Number 781069. Nuclear Magnetic Resonance Imaging System | Philips Medical Systems Nederland B.V. | LNH | |
| Z-0851-2019 | Class II | Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571 | Cook Incorporated | DYB | |
| Z-0938-2019 | Class II | Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766 | Zimmer GmbH | JWH | |
| Z-0937-2019 | Class II | Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764 | Zimmer GmbH | JWH | |
| Z-0765-2019 | Class I | Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The... | Edwards Lifesciences LLC | DYG | |
| Z-0764-2019 | Class I | Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The... | Edwards Lifesciences LLC | DYG | |
| Z-0763-2019 | Class I | Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of... | Edwards Lifesciences LLC | DYG | |
| Z-0762-2019 | Class I | Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The... | Edwards Lifesciences LLC | DYG | |
| Z-0744-2019 | Class I | ID Circuit Basic 180, Catalog Number MP01350 Breathing Circuits/Anesthesia Sets without... | Draeger, Inc. | OFP | |
| Z-0743-2019 | Class I | ID Circuit Basic 250, Catalog Number MP01348 Breathing Circuits/Anesthesia Sets without... | Draeger, Inc. | OFP | |
| Z-0742-2019 | Class I | ID Circuit Watertrap (P) 180, Catalog Number MP01341 Breathing Circuits/Anesthesia... | Draeger, Inc. | OFP | |
| Z-0741-2019 | Class I | VentStar Anesthesia WT(P) 180, Catalog Number MP00374 Breathing Circuits/Anesthesia... | Draeger, Inc. | OFP | |
| Z-0740-2019 | Class I | VentStar Watertrap (P) 180, Catalog Number MP00361 Breathing Circuits/Anesthesia Sets... | Draeger, Inc. | OFP | |
| Z-0739-2019 | Class I | VentStar Basic (P) 250, Catalog Number MP00352 Breathing Circuits/Anesthesia Sets... | Draeger, Inc. | OFP | |
| Z-0738-2019 | Class I | VentStar Basic (P) 180, Catalog Number MP00351 Breathing Circuits/Anesthesia Sets... | Draeger, Inc. | OFP | |
| Z-0737-2019 | Class I | VentStar Basic 250, Catalog Number MP00350 Breathing Circuits/Anesthesia Sets without a... | Draeger, Inc. | OFP | |
| Z-0736-2019 | Class I | VentStar Basic 180, Catalog Number MP00349 Breathing Circuits/Anesthesia Sets without a... | Draeger, Inc. | OFP | |
| Z-0972-2019 | Class II | Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter... | Zimmer GmbH | KWS | |
| Z-0996-2019 | Class II | AMSCO 5000 Series Washer/Disinfector Model # 5052 | STERIS Corporation | MEC | |
| Z-0995-2019 | Class II | AMSCO 3000 Series Washer/Disinfector Model # 3052 | STERIS Corporation | MEC | |
| Z-0966-2019 | Class II | Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222 | Terumo Cardiovascular Systems Corporation | OEZ | |
| Z-0793-2019 | Class II | GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Universal Viewer... | GE Healthcare | LLZ | |
| Z-0935-2019 | Class II | Phoenix AP AST Indicator Bag, Catalog Number 246006 | Becton Dickinson & Co | LON | |
| Z-0934-2019 | Class II | Phoenix AST Indicator, Catalog Number 246004 | Becton Dickinson & Co | LON | |
| Z-0933-2019 | Class II | Phoenix AST-s Indicator, Catalog Number 246009 | Becton Dickinson & Co | LON | |
| Z-0789-2019 | Class II | Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30108552-01 (c)... | Abbott Medical | JJE | |
| Z-0939-2019 | Class II | The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512... | Merge Healthcare Incorporated | HKI | |
| Z-0787-2019 | Class I | CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT... | Terrific Care LLC | GJS | |
| Z-1329-2019 | Class II | Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease... | Associates of Cape Cod, Inc. | NQZ | |
| Z-0823-2019 | Class II | Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging... | Philips North America LLC | KPS | |
| Z-0968-2019 | Class II | Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, Order Number... | Cook Incorporated | FGE | |
| Z-0967-2019 | Class II | Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, Order Number... | Cook Incorporated | FGE | |
| Z-0994-2019 | Class II | Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU... | Reckitt Benckiser LLC | MOL | |
| Z-0993-2019 | Class II | Durex Real Feel, synthetic polisoprene male condom, SKU... | Reckitt Benckiser LLC | MOL | |
| Z-0825-2019 | Class II | Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM... | Gentherm Medical, LLC | DWC | |
| Z-0790-2019 | Class II | Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034-0172PC 22mm... | Xtant Medical Holdings, Inc. | MAX | |
| Z-0802-2019 | Class II | ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800 | Arjohuntleigh Magog, Inc. | IKZ | |
| Z-0852-2019 | Class II | Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon... | Boston Scientific Corporation | DQX | |
| Z-0792-2020 | Class II | Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.) | Cochlear Americas | LXB | |
| Z-0347-2020 | Class II | Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1... | Insulet Corporation | LZG | |
| Z-0820-2019 | Class II | Aguja de Aspiration con Profundidad Ajustable Tipo I 15ga x 5 cm - Product Usage... | Argon Medical Devices, Inc | DWO |