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-2553-2023 | Class II | nanoDot kit (contains nanoDot A, B, C), Model Number 03500-000; radiation monitoring... | Landauer | IYE | |
| Z-2552-2023 | Class II | QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitoring... | Landauer | IYE | |
| Z-2551-2023 | Class II | QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitoring... | Landauer | IYE | |
| Z-2550-2023 | Class II | Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO; radiation monitoring... | Landauer | IYE | |
| Z-2549-2023 | Class II | Calibrate (80 kVp) screened nanoDot D2DNS, Model Number 03064-OTO; radiation monitoring... | Landauer | IYE | |
| Z-2548-2023 | Class II | nanoDot D2DXS, Model Numbers: a) 03063-1MO; b) 03063-3MO; c) 03063-OTO; d)... | Landauer | IYE | |
| Z-2547-2023 | Class II | nanoDot D2DXS, Model Numbers: a) 03062-1MO; b) 03062-3MO; c) 03062-OTO; d)... | Landauer | IYE | |
| Z-2546-2023 | Class II | nanoDot D2DXN, Model Numbers: a) 03061-1MO; b) 03061-3MO; c) 03061-OTO; d)... | Landauer | IYE | |
| Z-2545-2023 | Class II | nanoDot D2DXN, Model Numbers: a) 03060-1MO; b) 03060-3MO; c) 03060-OTO; d)... | Landauer | IYE | |
| Z-2544-2023 | Class II | nanoDot D2DNS, Model Numbers: a) 03057-1MO; b) 03057-3MO; c) 03057-OTO; d)... | Landauer | IYE | |
| Z-2543-2023 | Class II | nanoDot D2DNS, Model Numbers: a) 03056-000 (EMEA number VINLNAN002); b) 03056-1MO; c)... | Landauer | IYE | |
| Z-2542-2023 | Class II | nanoDot D2DNS, Model Numbers: a) 03055-1MO; b) 03055-3MO; c) 03055-OTO; d)... | Landauer | IYE | |
| Z-2541-2023 | Class II | nanoDot D2DNN, Model Numbers: a) 03053-1MO; b) 03053-1WK ; c) 03053-3MO; d)... | Landauer | IYE | |
| Z-2540-2023 | Class II | nanoDot D2DNN, Model Numbers: a) 03051-1MO; b) 03051-3MO; c) 03051-OTO; d)... | Landauer | IYE | |
| Z-2539-2023 | Class II | nanoDot D2DNS, for custom calibrate, OTO, Model Numbers 03034-OTO; radiation monitoring... | Landauer | IYE | |
| Z-2462-2023 | Class II | IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773... | Medicrea International | ODP | |
| Z-2461-2023 | Class II | IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S... | Medicrea International | MAX | |
| Z-2460-2023 | Class II | IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e)... | Medicrea International | ODP | |
| Z-2459-2023 | Class II | GRANVIA-C, REF numbers: a) A13111427, b) A13112567, c) A13113456, d) A13131516, e)... | Medicrea International | MJO | |
| Z-2363-2023 | Class II | CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K | Medtronic Sofamor Danek USA Inc | OLO | |
| Z-2458-2023 | Class II | PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z... | Medicrea International | MNI | |
| Z-2457-2023 | Class II | IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S... | Medicrea International | MAX | |
| Z-2456-2023 | Class II | IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743... | Medicrea International | ODP | |
| Z-2455-2023 | Class II | IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013... | Medicrea International | MAX | |
| Z-2454-2023 | Class II | IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar | Medicrea International | OVD | |
| Z-2453-2023 | Class II | IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412... | Medicrea International | MAX | |
| Z-2452-2023 | Class II | IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810... | Medicrea International | MAX | |
| Z-2488-2023 | Class II | Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2 | Siemens Healthcare Diagnostics Inc. | CFN | |
| Z-2447-2023 | Class II | The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC... | OLYMPUS Corporation of the Americas | FEB | |
| Z-2414-2023 | Class II | FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System | Abbott Medical | QLG | |
| Z-2256-2023 | Class II | The following Pro.specta Emission Computed Tomography Systems that were manufactured with... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2538-2023 | Class II | nanoDot D2DNS, for custom calibrate, OTO, Model Number 03033-OTO; radiation monitoring... | Landauer | IYE | |
| Z-2248-2023 | Class I | Carina Sub-Acute Care Ventilator | Draeger, Inc. | CBK | |
| Z-2442-2023 | Class II | EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter... | Boston Scientific Corporation | LWS | |
| Z-2441-2023 | Class II | EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter... | Boston Scientific Corporation | LWS | |
| Z-2474-2023 | Class II | Atellica CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination... | Siemens Healthcare Diagnostics Inc. | JFM | |
| Z-2473-2023 | Class II | Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative... | Siemens Healthcare Diagnostics Inc. | JFM | |
| Z-2472-2023 | Class II | Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of... | Siemens Healthcare Diagnostics Inc. | JFM | |
| Z-2471-2023 | Class II | Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination... | Siemens Healthcare Diagnostics Inc. | JFM | |
| Z-2463-2023 | Class II | SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the... | Stryker Corp. | PVZ | |
| Z-2589-2023 | Class II | Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only | Karl Storz Endoscopy-America, Inc. | EOQ | |
| Z-2475-2023 | Class II | LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral... | Alphatec Spine, Inc. | HWJ | |
| Z-2537-2023 | Class II | procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-GG023, b)... | Advance Medical Designs Inc | GDF | |
| Z-2536-2023 | Class II | Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b)... | Advance Medical Designs Inc | GDF | |
| Z-2535-2023 | Class II | Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b)... | Advance Medical Designs Inc | ITX | |
| Z-2534-2023 | Class II | Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b)... | Advance Medical Designs Inc | ITX | |
| Z-2533-2023 | Class II | 50-GEL20; Ultrasound gel | Advance Medical Designs Inc | MUI | |
| Z-2532-2023 | Class II | ASG-001; Ultrasound gel | Advance Medical Designs Inc | MUI | |
| Z-2594-2023 | Class II | SofTech Pressure-Sensing Wheelchair Cushions | Aquila Corporation | KNN | |
| Z-2593-2023 | Class II | APK2 Pressure-Sensing Wheelchair Cushions | Aquila Corporation | KNN |