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-0092-2018 | Class II | smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF... | Smith & Nephew, Inc. | JWH | |
| Z-0636-2018 | Class II | Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal... | Medtronic, Inc. | GDW | |
| Z-0775-2018 | Class II | 979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument. | Zimmer GmbH | LXH | |
| Z-0774-2018 | Class II | 14-442000S Antegrade Femoral Nail Instrument Kit, orthopedic instrument | Zimmer GmbH | LXH | |
| Z-0773-2018 | Class II | Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa, Model#14-442093... | Zimmer GmbH | LXH | |
| Z-3227-2017 | Class II | Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42... | Medtronic, Inc. | OTD | |
| Z-3240-2017 | Class II | SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE... | The Metrix Company | KPE | |
| Z-0725-2018 | Class II | Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The... | Terumo Medical Corp. | DYB | |
| Z-0926-2018 | Class II | i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List... | Abbott Medical | JQP | |
| Z-0815-2018 | Class II | OTTO BOCK Kenevo knee joints Model 3C60=ST | Otto Bock Healthcare Products GmbH | ISY | |
| Z-0814-2018 | Class II | OTTO BOCK Kenevo knee joints Model 3C60 | Otto Bock Healthcare Products GmbH | ISY | |
| Z-0353-2018 | Class II | LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest... | ZOLL Manufacturing Corporation | MVK | |
| Z-0024-2018 | Class II | Proclaim DRG Implantable Pulse Generator Model 3664 | Abbott Medical | LGW | |
| Z-0023-2018 | Class II | Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models... | Abbott Medical | MHY | |
| Z-0012-2018 | Class II | Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be... | Canon Medical Systems USA, Inc. | JAA | |
| Z-0022-2018 | Class II | Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse... | Abbott Medical | LGW | |
| Z-0609-2018 | Class II | BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic... | Zimmer GmbH | LYU | |
| Z-0111-2018 | Class II | Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281) | Medtronic, Inc. | FPK | |
| Z-0110-2018 | Class II | Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T... | Medtronic, Inc. | FPA | |
| Z-0109-2018 | Class II | Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 874T, 876... | Medtronic, Inc. | FPA | |
| Z-0108-2018 | Class II | Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T... | Medtronic, Inc. | FPA | |
| Z-0107-2018 | Class II | Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397... | Medtronic, Inc. | FPA | |
| Z-0810-2018 | Class II | AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant and is... | Howmedica Osteonics Corp | LXH | |
| Z-0624-2018 | Class II | JS Series SterilContainer S2 System | Aesculap Inc | KCT | |
| Z-0045-2018 | Class II | Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood... | Sysmex America, Inc. | KQC | |
| Z-0068-2018 | Class II | Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of... | Limacorporate S.p.A. | LXH | |
| Z-0013-2018 | Class II | PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered | Handicare USA, Inc. | FSA | |
| Z-0803-2018 | Class II | The 2nd Assist Knee Positioner | Zimmer GmbH | JEB | |
| Z-3237-2017 | Class II | AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas... | Radiometer America, Inc | JJS | |
| Z-0058-2018 | Class II | THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S | Biosense Webster Inc | LPB | |
| Z-0057-2018 | Class II | THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S) | Biosense Webster Inc | LPB | |
| Z-0056-2018 | Class II | THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S) | Biosense Webster Inc | LPB | |
| Z-0055-2018 | Class II | THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S... | Biosense Webster Inc | LPB | |
| Z-0054-2018 | Class II | THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S... | Biosense Webster Inc | LPB | |
| Z-0490-2019 | Class II | Irrisept OR, Finished Bottle Assembly 450 ml STEP 1 | Amsino Healthcare (USA) Inc. | FQH | |
| Z-0722-2019 | Class I | Medline Prefilled 550 ml Sterile | Amsino Healthcare (USA) Inc. | CAF | |
| Z-0721-2019 | Class I | Portex 5ml Normal Saline (0.9%) Unit Dose | Amsino Healthcare (USA) Inc. | CAF | |
| Z-0720-2019 | Class I | Portex Unit Dose 15 ml Normal Saline | Amsino Healthcare (USA) Inc. | CAF | |
| Z-0719-2019 | Class I | Portex Unit Dose 5 ml Normal Saline (0.9%) | Amsino Healthcare (USA) Inc. | CAF | |
| Z-0718-2019 | Class I | Medline Prefilled 350 ml Sterile | Amsino Healthcare (USA) Inc. | CAF | |
| Z-0717-2019 | Class I | Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt. | Amsino Healthcare (USA) Inc. | CAF | |
| Z-0716-2019 | Class I | Intermed 550 ml Sterile Water Humidifier w/5psi Adapt. | Amsino Healthcare (USA) Inc. | CAF | |
| Z-0715-2019 | Class I | Portex 550 ml Sterile Water Humidifier w/5psi Adapt. | Amsino Healthcare (USA) Inc. | CAF | |
| Z-0714-2019 | Class I | Intermed 350 ml Sterile Water Humidifier w/5psi Adapt. | Amsino Healthcare (USA) Inc. | CAF | |
| Z-0713-2019 | Class I | Portex 500 ml Sterile Water USP Pour Bottle | Amsino Healthcare (USA) Inc. | CAF | |
| Z-0712-2019 | Class I | Portex 1000 ml Sterile Water USP Pour Bottle | Amsino Healthcare (USA) Inc. | CAF | |
| Z-0711-2019 | Class I | Portex 550 ml Sterile Water Humidifier w/5psi Adapt. | Amsino Healthcare (USA) Inc. | CAF | |
| Z-0710-2019 | Class I | Portex 350 ml Sterile Water Humidifier w/5psi Adapt. | Amsino Healthcare (USA) Inc. | CAF | |
| Z-2537-2018 | Class II | Patient Positioning System with KRC2 controller using software versions 2.3.1... | Forte Automation Systems, Inc. | JAI | |
| Z-0621-2018 | Class II | ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 ELAN 4... | Aesculap Inc | HBE |