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-1337-2021 | Class I | Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA... | HeartWare, Inc. | DSQ | |
| Z-1336-2021 | Class I | Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH... | HeartWare, Inc. | DSQ | |
| Z-1284-2021 | Class II | CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable... | Caire Diagnostics, Inc. | MXA | |
| Z-1272-2021 | Class II | CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided... | Accuray Incorporated | IYE | |
| Z-1285-2021 | Class II | Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF... | Biosense Webster Inc | DYB | |
| Z-1335-2021 | Class II | BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used... | Medtronic, Inc. | FFT | |
| Z-1334-2021 | Class II | CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for... | Medtronic, Inc. | FFT | |
| Z-2204-2021 | Class I | Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment... | Bio Medical Equipment Service Company (Bmes) | FRN | |
| Z-2091-2021 | Class II | Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal... | Dutch Ophthalmic USA, Inc. | HMX | |
| Z-1332-2021 | Class I | Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410 | Tenacore LLC | FRN | |
| Z-1331-2021 | Class I | Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted... | Tenacore LLC | FRN | |
| Z-1304-2021 | Class II | Femoral Angiography Drape Bulk Non-Sterile | Medtronic, Inc. | PUI | |
| Z-1303-2021 | Class II | Femoral Angiography Drape Sterile | Medtronic, Inc. | PUI | |
| Z-1302-2021 | Class II | In-View Clear Leggings Bulk Non-Sterile | Medtronic, Inc. | ILG | |
| Z-1301-2021 | Class II | In-View Clear Leggings Sterile Non-Sterile | Medtronic, Inc. | ILG | |
| Z-1300-2021 | Class II | In-View Clear Leggings Sterile | Medtronic, Inc. | ILG | |
| Z-1333-2021 | Class II | BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model... | Biocare Medical LLC | KPA | |
| Z-1345-2021 | Class II | Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of... | Fenwal Inc | LKN | |
| Z-1344-2021 | Class II | Amicus Exchange Kit - Product Usage: intended for use in the collection of blood... | Fenwal Inc | LKN | |
| Z-1343-2021 | Class II | Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the... | Fenwal Inc | GKT | |
| Z-0199-2023 | Class II | Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally... | Access Vascular, Inc | LJS | |
| Z-0544-2022 | Class III | KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P... | Microbiologics, Inc. | JTR | |
| Z-0543-2022 | Class III | KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per... | Microbiologics, Inc. | JTR | |
| Z-1310-2021 | Class II | Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle... | Arthrex GmbH | HTW | |
| Z-1273-2021 | Class II | Philips CT systems are advanced continuous-rotation computed tomography systems suitable... | Philips Healthcare (Suzhou) Co., Ltd. | JAK | |
| Z-1468-2021 | Class II | Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide... | Trinity Sterile, Inc. | OXQ | |
| Z-1597-2021 | Class II | RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-1467-2021 | Class II | AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue... | Boston Scientific Corporation | DYB | |
| Z-1466-2021 | Class II | Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage... | Boston Scientific Corporation | LJT | |
| Z-1316-2021 | Class II | The ATTUNE Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple... | Depuy Orthopaedics Inc. | NJL | |
| Z-1315-2021 | Class II | The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage... | Depuy Orthopaedics Inc. | NJL | |
| Z-1314-2021 | Class II | ATTUNE FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral... | Depuy Orthopaedics Inc. | JWH | |
| Z-1265-2021 | Class II | Incisive CT Computed Tomography X-ray System Model: 728143 | Philips North America LLC | JAK | |
| Z-1322-2021 | Class II | EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French... | Epix Therapeutics, Inc | OAE | |
| Z-1321-2021 | Class II | EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French... | Epix Therapeutics, Inc | OAE | |
| Z-1320-2021 | Class II | EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French... | Epix Therapeutics, Inc | OAE | |
| Z-1319-2021 | Class II | EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.5 French... | Epix Therapeutics, Inc | OAE | |
| Z-1318-2021 | Class II | EPIX Therapeutics DiamondTemp Unidirectional Large Curve Ablation Catheter, 7.5 French... | Epix Therapeutics, Inc | OAE | |
| Z-1317-2021 | Class II | EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French... | Epix Therapeutics, Inc | OAE | |
| Z-1275-2021 | Class II | SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use. | Sirtex Medical Inc. | IWJ | |
| Z-1254-2021 | Class II | Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2. p/n... | Datascope Corp. | MSX | |
| Z-1409-2022 | Class II | Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope... | Aesculap Inc | FSO | |
| Z-1412-2021 | Class II | TASWako Chip Cassette is part of the Wako TASWako i30 kit | FUJIFILM Healthcare Americas Corporation | NSF | |
| Z-1295-2021 | Class II | VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to... | Ortho-Clinical Diagnostics, Inc. | JIX | |
| Z-1182-2021 | Class II | SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0... | Sunstar Americas, Inc. | LFD | |
| Z-1294-2021 | Class II | RUSCH POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of... | Teleflex Medical | CCW | |
| Z-1260-2021 | Class I | ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor... | Smisson-Cartledge Biomedical, LLC | LGZ | |
| Z-1259-2021 | Class I | ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor... | Smisson-Cartledge Biomedical, LLC | LGZ | |
| Z-1258-2021 | Class I | ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor... | Smisson-Cartledge Biomedical, LLC | LGZ | |
| Z-1417-2021 | Class II | MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND... | Vectornate USA Inc | JSG |