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-1551-2025 | Class II | Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223. | Siemens Healthcare Diagnostics Inc. | DCN | |
| Z-1507-2025 | Class I | BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483... | Bard Access Systems, Inc. | LJS | |
| Z-1550-2025 | Class II | BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR... | CareFusion 303, Inc | BRY | |
| Z-1623-2025 | Class II | NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE... | Medtronic Xomed, Inc. | GWF | |
| Z-1554-2025 | Class II | Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System. | Philips North America LLC | KPR | |
| Z-1553-2025 | Class II | Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System. | Philips North America LLC | KPR | |
| Z-1577-2025 | Class II | Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview... | Maquet Cardiovascular LLC | GEI | |
| Z-1561-2025 | Class II | TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002; | Straumann USA, LLC | NDP | |
| Z-1516-2025 | Class II | Ethibond Excel Grn 36In(90cm) Usp2-0(M3) D/a Mh | Ethicon Endo-Surgery Inc | NEW | |
| Z-1515-2025 | Class II | Prolene Blu 18In(45cm) Usp6-0(M0.7) S/a P-1 Prm | Ethicon Endo-Surgery Inc | NEW | |
| Z-1514-2025 | Class II | Pdsiivio30in(75cm)usp6-0(M0.7)d/ac-1 | Ethicon Endo-Surgery Inc | NEW | |
| Z-1513-2025 | Class II | Pdsplusvio30in(75cm)usp6-0(M0.7)d/ac-1Mp | Ethicon Endo-Surgery Inc | NEW | |
| Z-1556-2025 | Class II | Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS... | GE Healthcare | IYN | |
| Z-1555-2025 | Class II | Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number... | GE Healthcare | IYN | |
| Z-1503-2025 | Class II | Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time... | Fisher Diagnostics | GJS | |
| Z-1502-2025 | Class II | Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time... | Fisher Diagnostics | GJS | |
| Z-1813-2025 | Class II | HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607 | Advanced Bionics LLC | MCM | |
| Z-1542-2025 | Class II | stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty | Tornier S.A.S. | OLO | |
| Z-1549-2025 | Class II | MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue)... | MEDLINE INDUSTRIES, LP - Northfield | GEI | |
| Z-1548-2025 | Class II | MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline... | MEDLINE INDUSTRIES, LP - Northfield | GEI | |
| Z-1547-2025 | Class II | MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number... | MEDLINE INDUSTRIES, LP - Northfield | GEI | |
| Z-1546-2025 | Class II | MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line &... | MEDLINE INDUSTRIES, LP - Northfield | GEI | |
| Z-1541-2025 | Class II | stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder... | Tornier S.A.S. | OLO | |
| Z-1540-2025 | Class II | stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder... | Tornier S.A.S. | OLO | |
| Z-1539-2025 | Class II | stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in... | Tornier S.A.S. | OLO | |
| Z-1538-2025 | Class II | stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker... | Tornier S.A.S. | OLO | |
| Z-1537-2025 | Class II | stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged... | Tornier S.A.S. | OLO | |
| Z-1536-2025 | Class II | stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in... | Tornier S.A.S. | OLO | |
| Z-1535-2025 | Class II | stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in... | Tornier S.A.S. | OLO | |
| Z-1534-2025 | Class II | stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog... | Tornier S.A.S. | OLO | |
| Z-1573-2025 | Class II | Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number... | Abbott Diagnostics Scarborough, Inc. | OCC | |
| Z-1572-2025 | Class II | Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2... | Abbott Diagnostics Scarborough, Inc. | OZE | |
| Z-1571-2025 | Class II | Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog... | Abbott Diagnostics Scarborough, Inc. | QWR | |
| Z-1576-2025 | Class II | Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number... | Abbott Diagnostics Scarborough, Inc. | OCC | |
| Z-1575-2025 | Class II | Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2... | Abbott Diagnostics Scarborough, Inc. | OZE | |
| Z-1574-2025 | Class II | Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog... | Abbott Diagnostics Scarborough, Inc. | QWR | |
| Z-1533-2025 | Class I | Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT... | ZOLL Circulation, Inc. | DRM | |
| Z-1543-2025 | Class II | Stimulation RC Clinician Programmer Application, Model A71400, when used with the... | Medtronic Neuromodulation | LGW | |
| Z-1511-2025 | Class II | Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F... | Cordis US Corp. | NIO | |
| Z-1510-2025 | Class II | Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F... | Cordis US Corp. | NIO | |
| Z-1650-2025 | Class II | InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA... | Medtronic, Inc. | FMF | |
| Z-1619-2025 | Class II | Medline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GENOU-LF, Model... | MEDLINE INDUSTRIES, LP - Northfield | OII | |
| Z-1618-2025 | Class II | Refer to RES | MEDLINE INDUSTRIES, LP - Northfield | OJH | |
| Z-1617-2025 | Class II | Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Model Number... | MEDLINE INDUSTRIES, LP - Northfield | OJK | |
| Z-1616-2025 | Class II | Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK, Model... | MEDLINE INDUSTRIES, LP - Northfield | OKV | |
| Z-1615-2025 | Class II | Medline Convenience kits used for various procedures: 1) PERI GYN PACK, Model Number... | MEDLINE INDUSTRIES, LP - Northfield | OJF | |
| Z-1614-2025 | Class II | Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRAY, Model... | MEDLINE INDUSTRIES, LP - Northfield | OHM | |
| Z-1613-2025 | Class II | Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model Number... | MEDLINE INDUSTRIES, LP - Northfield | OHD | |
| Z-1612-2025 | Class II | Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number... | MEDLINE INDUSTRIES, LP - Northfield | MLT | |
| Z-1611-2025 | Class II | Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF... | MEDLINE INDUSTRIES, LP - Northfield | MLS |