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-1181-2019 | Class II | Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC | Gyrus ACMI, Inc. | GEI | |
| Z-1180-2019 | Class II | Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS | Gyrus ACMI, Inc. | GEI | |
| Z-1179-2019 | Class II | Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No... | Gyrus ACMI, Inc. | GEI | |
| Z-1178-2019 | Class II | Olympus Diego Elite Console MDCONS 100 | Gyrus ACMI, Inc. | GEI | |
| Z-1175-2019 | Class II | Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T | Integra LifeSciences Corporation | HSN | |
| Z-1174-2019 | Class II | Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192T | Integra LifeSciences Corporation | HSN | |
| Z-1173-2019 | Class II | Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191T | Integra LifeSciences Corporation | HSN | |
| Z-1172-2019 | Class II | Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T | Integra LifeSciences Corporation | HSN | |
| Z-1171-2019 | Class II | Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Right, Product No. LJV183T | Integra LifeSciences Corporation | HSN | |
| Z-1170-2019 | Class II | Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182T | Integra LifeSciences Corporation | HSN | |
| Z-1169-2019 | Class II | Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Right, Product No. LJV181T | Integra LifeSciences Corporation | HSN | |
| Z-1168-2019 | Class II | Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T | Integra LifeSciences Corporation | HSN | |
| Z-1167-2019 | Class II | Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T | Integra LifeSciences Corporation | HSN | |
| Z-1166-2019 | Class II | Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Right, Product No. LJU812T | Integra LifeSciences Corporation | HSN | |
| Z-1165-2019 | Class II | Talar Dome Total Ankle Prosthesis , Flat Cut, Size 1, Right, Product No. LJU811T | Integra LifeSciences Corporation | HSN | |
| Z-1164-2019 | Class II | Talar Dome Total Ankle Prosthesis , Flat Cut, Size 3, Left, Product No. LJU823T | Integra LifeSciences Corporation | HSN | |
| Z-1163-2019 | Class II | Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822T | Integra LifeSciences Corporation | HSN | |
| Z-1162-2019 | Class II | Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No. LJU821T | Integra LifeSciences Corporation | HSN | |
| Z-1161-2019 | Class II | Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T | Integra LifeSciences Corporation | HSN | |
| Z-1160-2019 | Class II | Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T | Integra LifeSciences Corporation | HSN | |
| Z-1159-2019 | Class II | Tibial Total Ankle Prosthesis Tray, Size 1, Product No. LJU221T | Integra LifeSciences Corporation | HSN | |
| Z-1158-2019 | Class II | Tibial Total Ankle Prosthesis Tray, Size 0, Product No. LJU220T | Integra LifeSciences Corporation | HSN | |
| Z-1157-2019 | Class II | Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Left, Part No... | Integra LifeSciences Corporation | HSN | |
| Z-1156-2019 | Class II | Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Left, Part No... | Integra LifeSciences Corporation | HSN | |
| Z-1155-2019 | Class II | Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 1, Left, Part No... | Integra LifeSciences Corporation | HSN | |
| Z-1154-2019 | Class II | Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Left, Part No... | Integra LifeSciences Corporation | HSN | |
| Z-1153-2019 | Class II | Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Right, Part No... | Integra LifeSciences Corporation | HSN | |
| Z-1152-2019 | Class II | Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Right, Part No... | Integra LifeSciences Corporation | HSN | |
| Z-1151-2019 | Class II | Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right, Part No. LJU201T | Integra LifeSciences Corporation | HSN | |
| Z-1150-2019 | Class II | Salto Talaris, Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Right, Part No... | Integra LifeSciences Corporation | HSN | |
| Z-1301-2019 | Class II | Atellica Sample Handler Prime, Material Number 11069001 | Siemens Healthcare Diagnostics Inc. | JGS | |
| Z-1300-2019 | Class II | Atellica IM 1600 Analyzer, Material Number 11066000 | Siemens Healthcare Diagnostics Inc. | JLW | |
| Z-1299-2019 | Class II | Atellica IM 1300 Analyzer, Material Number 11066001 | Siemens Healthcare Diagnostics Inc. | JLW | |
| Z-1728-2019 | Class II | Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an... | Stryker Corp. | HIF | |
| Z-1727-2019 | Class II | Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an... | Stryker Corp. | HIF | |
| Z-1726-2019 | Class II | Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High... | Stryker Corp. | HIF | |
| Z-1316-2019 | Class II | Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with... | Abbott Medical | JJE | |
| Z-1133-2019 | Class II | FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and... | BioFire Diagnostics, LLC | PEN | |
| Z-0252-2020 | Class II | BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608 | Becton Dickinson & Co | FMI | |
| Z-1122-2019 | Class II | BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010 | Becton Dickinson & Co | JKA | |
| Z-0826-2020 | Class II | TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891 | Acclarent Inc | PGW | |
| Z-0825-2020 | Class II | TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884 | Acclarent Inc | PGW | |
| Z-0824-2020 | Class II | TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877 | Acclarent Inc | PGW | |
| Z-1110-2019 | Class II | AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam... | PROCEPT BioRobotics Corporation | PZP | |
| Z-1242-2019 | Class II | FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF... | BioFire Diagnostics, LLC | PCH | |
| Z-1138-2019 | Class II | IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is... | Topcon Healthcare, Inc. | NFJ | |
| Z-1209-2019 | Class II | Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the... | Fenwal Inc | CAC | |
| Z-1121-2019 | Class II | Gravity IV Set with 3-port Closed Stopcock Manifold Model CM42500E-07 | Becton Dickinson & Co | FPA | |
| Z-1120-2019 | Class II | Gravity IV Set with 3-port Closed Stopcock Manifold Model CS42522E-07 | Becton Dickinson & Co | FPA | |
| Z-1069-2019 | Class III | Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage... | Medtronic, Inc. | OAE |