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-0889-2022 | Class II | Brius Patient Specific Brackets (components in a set of custom metal orthodontic... | BRIUS Technologies Inc. | DYJ | |
| Z-0888-2022 | Class II | Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only... | BRIUS Technologies Inc. | DYJ | |
| Z-0882-2022 | Class II | Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS... | Philips North America LLC | MKJ | |
| Z-0881-2022 | Class II | Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1... | Philips North America LLC | MKJ | |
| Z-0814-2022 | Class III | TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows... | Cytocell Limited | MVU | |
| Z-0695-2022 | Class I | Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number... | Medtronic, Inc. | MCW | |
| Z-0694-2022 | Class I | Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number... | Medtronic, Inc. | MCW | |
| Z-0949-2022 | Class II | Cardiovascular Procedure Kit catalog # 76645 & 73806 | Terumo Cardiovascular Systems Corporation | OEZ | |
| Z-0917-2022 | Class III | MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers... | Volcano Corporation | DSA | |
| Z-0749-2022 | Class II | Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI... | Abbott Medical | MZA | |
| Z-0874-2022 | Class II | Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and... | Philips North America LLC | LLZ | |
| Z-0737-2022 | Class II | Philips StentBoost Live R2.0 application, when used with the Philips Azurion with... | Philips North America LLC | OWB | |
| Z-0823-2022 | Class II | NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial... | Ace Surgical Supply Co., Inc. | NPM | |
| Z-0827-2022 | Class II | Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808) | Mevion Medical Systems, Inc. | LHN | |
| Z-0691-2022 | Class II | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198 | Biopro, Inc. | KWD | |
| Z-0690-2022 | Class II | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197 | Biopro, Inc. | KWD | |
| Z-0689-2022 | Class II | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038 | Biopro, Inc. | KWD | |
| Z-0688-2022 | Class II | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037 | Biopro, Inc. | KWD | |
| Z-0687-2022 | Class II | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036 | Biopro, Inc. | KWD | |
| Z-0686-2022 | Class II | Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035 | Biopro, Inc. | KWD | |
| Z-0685-2022 | Class II | Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816 | Biopro, Inc. | KWD | |
| Z-0684-2022 | Class II | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815 | Biopro, Inc. | KWD | |
| Z-0683-2022 | Class II | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814 | Biopro, Inc. | KWD | |
| Z-0682-2022 | Class II | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813 | Biopro, Inc. | KWD | |
| Z-1228-2022 | Class II | (1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and... | BSN Medical | FQM | |
| Z-1666-2022 | Class II | INFX-8000V. For radiographic and fluoroscopic studies and intervention. | Canon Medical Systems USA, Inc. | OWB | |
| Z-0841-2022 | Class II | Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system | Siemens Medical Solutions USA, Inc. | KPR | |
| Z-0719-2022 | Class I | STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid... | SD Biosensor, Inc. | QKP | |
| Z-0727-2022 | Class II | Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin... | B Braun Medical Inc | LHI | |
| Z-0873-2022 | Class II | Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity... | B Braun Medical Inc | KDI | |
| Z-0872-2022 | Class II | Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity... | B Braun Medical Inc | KDI | |
| Z-0830-2022 | Class II | Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158... | Siemens Healthcare Diagnostics Inc. | JGJ | |
| Z-0861-2022 | Class II | Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI... | Remote Diagnostic Technologies Ltd. | LDD | |
| Z-0808-2022 | Class II | GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF... | GE Healthcare | DXJ | |
| Z-0707-2022 | Class II | Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S | Brasseler USA I, L.P. | HTY | |
| Z-0789-2022 | Class II | SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09 | Sam Medical Products | NAD | |
| Z-0420-2023 | Class II | LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated... | Integrity Implants, Inc. | NKB | |
| Z-0419-2023 | Class II | LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated... | Integrity Implants, Inc. | NKB | |
| Z-0418-2023 | Class II | LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated... | Integrity Implants, Inc. | NKB | |
| Z-0003-2023 | Class II | The product is a handheld ultraviolet-C germicidal wand and contains two... | In My Bathroom LLC | RHP | |
| Z-0855-2022 | Class II | MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742... | Medtronic, Inc. | OZP | |
| Z-0726-2022 | Class II | HeartWare Ventricular Assist Device (HVAD) System | HeartWare, Inc. | DSQ | |
| Z-0750-2022 | Class II | Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System... | Hologic, Inc. | JTW | |
| Z-0564-2022 | Class I | E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit | E25Bio, Inc. | QKP | |
| Z-0667-2022 | Class II | BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C | C.R. Bard Inc | KOD | |
| Z-0666-2022 | Class II | BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C | C.R. Bard Inc | KOD | |
| Z-0736-2022 | Class II | CoolSeal Generator, REF: CSL-200-50 | Bolder Surgical, LLC | GEI | |
| Z-0678-2022 | Class II | meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The... | MEDLINE INDUSTRIES, LP - Northfield | LIQ | |
| Z-0901-2022 | Class III | IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102 | Volcano Corporation | IYO | |
| Z-0947-2022 | Class II | Matrix Clinical Solution At-Home COVID-19 Test | Matrix Medical Network | QLW |