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-1519-2023 | Class II | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 55MM Item Number: 15-2028/09 | LinkBio Corp. | HSX | |
| Z-1518-2023 | Class II | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 50MM Item Number: 15-2028/08 | LinkBio Corp. | HSX | |
| Z-1517-2023 | Class II | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Number: 15-2028/07 | LinkBio Corp. | HSX | |
| Z-1516-2023 | Class II | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 50MM Item Number: 15-2028/06 | LinkBio Corp. | HSX | |
| Z-1515-2023 | Class II | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 50MM Item Number: 15-2028/05 | LinkBio Corp. | HSX | |
| Z-1514-2023 | Class II | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 45MM Item Number: 15-2028/04 | LinkBio Corp. | HSX | |
| Z-1513-2023 | Class II | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Item Number: 15-2028/03 | LinkBio Corp. | HSX | |
| Z-1512-2023 | Class II | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 45MM Item Number: 15-2028/02 | LinkBio Corp. | HSX | |
| Z-1511-2023 | Class II | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 45MM Item Number: 15-2028/01 | LinkBio Corp. | HSX | |
| Z-1510-2023 | Class II | LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-2020/60 | LinkBio Corp. | HSX | |
| Z-1509-2023 | Class II | LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2020/52 | LinkBio Corp. | HSX | |
| Z-1508-2023 | Class II | LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2020/46 | LinkBio Corp. | HSX | |
| Z-1507-2023 | Class II | LINK SLED Knee System: ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2020/40 | LinkBio Corp. | HSX | |
| Z-1569-2023 | Class II | Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device... | Aesculap Inc | GEI | |
| Z-1578-2023 | Class II | COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX... | Merit Medical Systems, Inc. | DYB | |
| Z-1586-2023 | Class II | Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813 | Philips North America LLC | JAK | |
| Z-1585-2023 | Class II | Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814 | Philips North America LLC | JAK | |
| Z-1506-2023 | Class II | DERMLITE DL4W, REF: DL4W, Rx Only MD, CE | DermLite LLC | KYT | |
| Z-1420-2023 | Class II | ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication... | Baxter Healthcare Corporation | KYX | |
| Z-1584-2023 | Class II | Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333 | Philips North America LLC | JAK | |
| Z-1476-2023 | Class II | Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44... | STERIS Corporation | FTA | |
| Z-1475-2023 | Class II | Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical... | STERIS Corporation | FTA | |
| Z-1497-2023 | Class II | CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a... | Becton Dickinson & Co | HPS | |
| Z-1408-2023 | Class II | Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used... | Medtronic Neuromodulation | MHY | |
| Z-1971-2023 | Class II | Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre... | Ellex Medical Pty Ltd | HQF | |
| Z-1505-2023 | Class II | ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T... | Siemens Healthcare Diagnostics Inc. | JFT | |
| Z-1504-2023 | Class II | Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and... | Siemens Healthcare Diagnostics Inc. | JFT | |
| Z-1426-2023 | Class II | JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S... | Spineart SA | OVD | |
| Z-1421-2023 | Class II | (1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1... | Medtronic, Inc. | HDF | |
| Z-1419-2023 | Class II | Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box... | Siemens Healthcare Diagnostics Inc. | CDP | |
| Z-1698-2024 | Class II | ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop... | Advanced Research Medical | MAX | |
| Z-1429-2023 | Class II | Hamilton-C6, Ref: 160021 | Hamilton Medical AG | CBK | |
| Z-0224-2025 | Class II | Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood... | Spectrum Medical Inc | DTQ | |
| Z-1557-2023 | Class II | VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-1556-2023 | Class II | VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-1555-2023 | Class II | VITROS XT 7600 Integrated System - For use in the in vitro quantitative... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-1563-2023 | Class II | Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same... | Inpeco S.p.A. | CEM | |
| Z-1562-2023 | Class II | Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the... | Inpeco S.p.A. | CEM | |
| Z-1561-2023 | Class II | PVT Interface Module (PVT)-Laboratory Automation system Brand names of the same product... | Inpeco S.p.A. | CEM | |
| Z-1560-2023 | Class II | Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same... | Inpeco S.p.A. | CEM | |
| Z-1559-2023 | Class II | Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same... | Inpeco S.p.A. | CEM | |
| Z-1386-2023 | Class II | stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in... | Howmedica Osteonics Corp | HSX | |
| Z-1385-2023 | Class II | stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in... | Howmedica Osteonics Corp | HSX | |
| Z-1291-2023 | Class II | Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS... | Alcon Laboratories | LRO | |
| Z-1313-2023 | Class I | Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004 | Fresenius Kabi USA, LLC | FRN | |
| Z-1396-2023 | Class II | VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed... | Ortho-Clinical Diagnostics, Inc. | QKO | |
| Z-1558-2023 | Class II | DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK... | Sunrise Medical, Inc. | CAW | |
| Z-1383-2023 | Class II | DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human... | Philips North America LLC | KPR | |
| Z-1382-2023 | Class II | Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human... | Philips North America LLC | KPR | |
| Z-1414-2023 | Class II | Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System | Samsung HME America, Inc. | IZL |