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-0084-2019 | Class II | OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNCRCD39-L. | Orthosensor, Inc. | ONN | |
| Z-0083-2019 | Class II | OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R. | Orthosensor, Inc. | ONN | |
| Z-0082-2019 | Class II | OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L. | Orthosensor, Inc. | ONN | |
| Z-2965-2018 | Class II | Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used... | Zimmer GmbH | HRS | |
| Z-0061-2019 | Class II | VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997 | Ortho-Clinical Diagnostics, Inc. | JLW | |
| Z-0060-2019 | Class II | VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793 | Ortho-Clinical Diagnostics, Inc. | CFT | |
| Z-0059-2019 | Class II | VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922 | Ortho-Clinical Diagnostics, Inc. | CGJ | |
| Z-0058-2019 | Class II | VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266 | Ortho-Clinical Diagnostics, Inc. | CGN | |
| Z-2942-2018 | Class II | DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT, ; RAULERSON DUO FLOW IJ DOUBLE LUMEN... | Medical Components, Inc. | MPB | |
| Z-2941-2018 | Class II | Duo Flow Custom Trays; Tray #414 Tray #415 Tray #67 | Medical Components, Inc. | MPB | |
| Z-2940-2018 | Class II | Soft-Line Duo-Flow Double Lumen Catheter/catheter Set; T94c T94m T96m T98m | Medical Components, Inc. | MPB | |
| Z-2939-2018 | Class II | Soft-Line Duo-Flow Double Lumen Catheter Tray; T3500 T4000 T4400 T4424 | Medical Components, Inc. | MPB | |
| Z-2938-2018 | Class II | Duo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114M T116C T116M T116ME T118C... | Medical Components, Inc. | MPB | |
| Z-2937-2018 | Class II | Duo-Flow XTP Straight Full Set, RMS02105 RMS02108 | Medical Components, Inc. | MPB | |
| Z-2936-2018 | Class II | Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis... | Medical Components, Inc. | MPB | |
| Z-2935-2018 | Class II | Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ | Medical Components, Inc. | MPB | |
| Z-2934-2018 | Class II | Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Set; DL11/24 . Hemodialysis catheter... | Medical Components, Inc. | MPB | |
| Z-2933-2018 | Class II | Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL 11/15 DL... | Medical Components, Inc. | MPB | |
| Z-2932-2018 | Class II | Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits... | Medical Components, Inc. | MPB | |
| Z-2597-2018 | Class II | power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System... | Baxter Healthcare Corporation | FKX | |
| Z-0262-2020 | Class II | POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as... | POM Medical, LLC | BYG | |
| Z-3208-2018 | Class II | P400 PREM U/M 16FR TMPSNS, Item Code P4P16TS | Medtronic, Inc. | KOD | |
| Z-3207-2018 | Class II | P400 PREM U/M 18FR TMPSNS, Item Code P4P18TS | Medtronic, Inc. | KOD | |
| Z-3206-2018 | Class II | 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith... | Medtronic, Inc. | KOD | |
| Z-3205-2018 | Class II | 400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith... | Medtronic, Inc. | KOD | |
| Z-3204-2018 | Class II | TEMP SENSE SILICONE 14FR5CC2W, Item Code 50514T | Medtronic, Inc. | KOD | |
| Z-3203-2018 | Class II | 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith... | Medtronic, Inc. | KOD | |
| Z-3193-2018 | Class III | VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA... | Ortho-Clinical Diagnostics, Inc. | JFY | |
| Z-3184-2018 | Class III | VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl... | Ortho-Clinical Diagnostics, Inc. | CGZ | |
| Z-3044-2018 | Class III | VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage For in vitro... | Ortho-Clinical Diagnostics, Inc. | JIX | |
| Z-3043-2018 | Class III | VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro... | Ortho-Clinical Diagnostics, Inc. | CGZ | |
| Z-2589-2018 | Class I | Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly... | GE Healthcare | CBK | |
| Z-1692-2020 | Class II | djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and... | Encore Medical, LP | LPH | |
| Z-2819-2018 | Class II | HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2818-2018 | Class II | HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-1702-2020 | Class II | ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol... | Merit Medical Systems, Inc. | OEQ | |
| Z-2825-2018 | Class II | Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and... | Sorin CRM SAS | NIK | |
| Z-2824-2018 | Class II | Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and... | Sorin CRM SAS | NIK | |
| Z-2733-2018 | Class II | Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product Usage; Device... | Mallinckrodt Manufacturing LLC | MRN | |
| Z-2603-2018 | Class II | Medtronic CD HORIZON Spinal System is intended to help provide immobilization and... | Medtronic Sofamor Danek USA Inc | NKB | |
| Z-0598-2019 | Class II | UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle... | Neotract Inc | PEW | |
| Z-0075-2019 | Class III | smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring... | Abbott Medical | CAT | |
| Z-0074-2019 | Class III | smiths medical portex First Breath Nasal Oxygen Cannula, REF 001292, with Gas Monitoring... | Abbott Medical | CAT | |
| Z-0073-2019 | Class III | smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips... | Abbott Medical | CAT | |
| Z-0368-2019 | Class II | 3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack... | 3M Company | LBH | |
| Z-0072-2019 | Class III | smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Tips, 213 cm... | Abbott Medical | CAT | |
| Z-0071-2019 | Class III | smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213... | Abbott Medical | CAT | |
| Z-1031-2019 | Class II | CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050 | CTL Medical Corporation | NKB | |
| Z-1030-2019 | Class II | CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050 | CTL Medical Corporation | MNI | |
| Z-2972-2018 | Class I | DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open... | Black Forest Medical GmbH | HBL |