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-2416-2018 | Class II | Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and... | Medtronic, Inc. | LWS | |
| Z-1248-2019 | Class II | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code... | Baxter Healthcare Corporation | FRN | |
| Z-2521-2018 | Class II | CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511 | Depuy Orthopaedics Inc. | KWL | |
| Z-0444-2019 | Class II | Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5... | Fannin (UK) Limited | GCJ | |
| Z-2826-2018 | Class I | The Tri-Flo Subglottic Suction System | Jaeger Medical GmbH | BSY | |
| Z-0202-2019 | Class II | Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model... | Boston Scientific Corporation | OAD | |
| Z-0498-2019 | Class II | Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic... | Stryker Sustainability Solutions | NLM | |
| Z-3042-2018 | Class II | AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the... | LeMaitre Vascular Inc. | HBT | |
| Z-2822-2018 | Class II | NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part... | Nico Corporation | GZT | |
| Z-3026-2018 | Class II | VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910... | Vascular Technology Incorporated | DPW | |
| Z-2740-2018 | Class II | Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery. | Becton Dickinson & Co | HNN | |
| Z-2741-2018 | Class I | CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L Product... | Compass Health Brands (Corporate Office) | BZD | |
| Z-0198-2019 | Class II | J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece... | Apyx Medical Corporation | GEI | |
| Z-2875-2018 | Class II | Connecting Bolt, Model 14-442093 | Zimmer GmbH | LXH | |
| Z-2479-2018 | Class II | Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging device and is... | FUJIFILM Healthcare Americas Corporation | LNH | |
| Z-0197-2019 | Class II | TRINIAS Digital Angiographic System intended to be used for cardiac angiography... | Shimadzu Medical Systems | OWB | |
| Z-3210-2018 | Class II | Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a... | MEDLINE INDUSTRIES, LP - Northfield | MNL | |
| Z-2601-2018 | Class II | Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955 | Medtronic, Inc. | GAM | |
| Z-0655-2019 | Class III | RT-5100 Refractor, a component of the Epic-5100 System. | Nidek Incorporated | HKN | |
| Z-2502-2018 | Class II | VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM... | Maquet SAS | FTD | |
| Z-2522-2018 | Class II | CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics... | Abbott Medical | MOM | |
| Z-0064-2019 | Class II | Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The... | Leica Microsystems, Inc. | KPA | |
| Z-2832-2018 | Class II | TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for marking and... | Beekley Corporation | JAC | |
| Z-2831-2018 | Class II | S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography. | Beekley Corporation | JAC | |
| Z-2830-2018 | Class II | O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography. | Beekley Corporation | JAC | |
| Z-2536-2018 | Class II | Arctic Sun Temperature Management System, Model 5000. The Arctic Sun 5000 model is a... | C.R. Bard Inc | DWJ | |
| Z-0003-2019 | Class II | JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113... | Smith & Nephew, Inc. | JWH | |
| Z-0002-2019 | Class II | JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111... | Smith & Nephew, Inc. | JWH | |
| Z-0001-2019 | Class II | Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212... | Smith & Nephew, Inc. | JWH | |
| Z-0785-2022 | Class I | Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device... | Respironics, Inc. | CBK | |
| Z-2969-2018 | Class II | Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea... | Inspire Medical Systems Inc | MNQ | |
| Z-2287-2018 | Class II | Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542 Product Usage: general... | Teleflex Medical | LRW | |
| Z-0206-2019 | Class II | MyLab Seven, Model 6400 | Esaote S.p.A. | IYN | |
| Z-0205-2019 | Class II | MyLab Gamma, Model 7410 | Esaote S.p.A. | IYN | |
| Z-0204-2019 | Class II | MyLab Alpha, Model 7400 | Esaote S.p.A. | IYN | |
| Z-2500-2018 | Class II | Centron Product Usage: Vascular,cardiovascular and neurovascular imaging... | Philips North America LLC | OWB | |
| Z-2499-2018 | Class II | UNIQ Product Usage: Vascular,cardiovascular and neurovascular imaging... | Philips North America LLC | OWB | |
| Z-2829-2018 | Class II | Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure... | Withings SAS | DXN | |
| Z-2793-2018 | Class II | NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product... | NxStage Medical Inc | KDI | |
| Z-2498-2018 | Class II | Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging... | Philips North America LLC | OWB | |
| Z-2435-2018 | Class II | Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm | Edwards Lifesciences LLC | NPT | |
| Z-2440-2018 | Class II | MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pediatric Use... | Canadian Hospital Specialties Ltd. | FPD | |
| Z-2495-2018 | Class II | Hydroline Trumpet Valve, Trumpet Valve, No Probe, Double Spike, Ref ASU1221, packaged... | Medtronic, Inc. | GBX | |
| Z-2494-2018 | Class II | Hydroline Trumpet Valve, Trumpet Valve, No Probe, Single Spike, Ref ASU1220, packaged... | Medtronic, Inc. | GBX | |
| Z-2493-2018 | Class II | Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Double Spike, Ref ASU1211... | Medtronic, Inc. | GBX | |
| Z-2492-2018 | Class II | Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Single Spike, Ref ASU1210... | Medtronic, Inc. | GBX | |
| Z-2491-2018 | Class II | Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Double Spike, Ref ASU1201... | Medtronic, Inc. | GBX | |
| Z-2490-2018 | Class II | Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Single Spike, Ref ASU1200... | Medtronic, Inc. | GBX | |
| Z-2489-2018 | Class II | Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Double Spike and no... | Medtronic, Inc. | GBX | |
| Z-2488-2018 | Class II | Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Single Spike and no... | Medtronic, Inc. | GBX |