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-1484-2025 | Class II | GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2)... | GE Healthcare | LLZ | |
| Z-1483-2025 | Class II | GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2)... | GE Healthcare | LLZ | |
| Z-1402-2025 | Class II | Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2... | Merge Healthcare Incorporated | LLZ | |
| Z-1401-2025 | Class II | VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1... | Merge Healthcare Incorporated | LLZ | |
| Z-1400-2025 | Class II | VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: 11.0.2... | Merge Healthcare Incorporated | LLZ | |
| Z-1399-2025 | Class II | VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0... | Merge Healthcare Incorporated | LLZ | |
| Z-1398-2025 | Class II | VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and... | Merge Healthcare Incorporated | LLZ | |
| Z-1396-2025 | Class I | CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic... | Calyxo, Inc. | FED | |
| Z-1267-2025 | Class II | MIM software; System, Image Processing, Radiological | MIM Software Inc | LLZ | |
| Z-1303-2025 | Class II | GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed | GE Healthcare | JAK | |
| Z-1302-2025 | Class II | GE Healthcare Revolution CT, System, X-ray, Tomography, Computed | GE Healthcare | JAK | |
| Z-1301-2025 | Class II | GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed | GE Healthcare | JAK | |
| Z-1300-2025 | Class II | GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed | GE Healthcare | JAK | |
| Z-1299-2025 | Class II | GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed | GE Healthcare | JAK | |
| Z-1298-2025 | Class II | GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed | GE Healthcare | JAK | |
| Z-1297-2025 | Class II | GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed | GE Healthcare | JAK | |
| Z-1305-2025 | Class I | BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software | CareFusion 303, Inc | PHC | |
| Z-1304-2025 | Class I | BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software | CareFusion 303, Inc | PHC | |
| Z-0407-2026 | Class II | Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF; | Daye (Anne's Day Ltd) | HEB | |
| Z-0406-2026 | Class II | Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF; | Daye (Anne's Day Ltd) | HEB | |
| Z-0405-2026 | Class II | Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO; | Daye (Anne's Day Ltd) | HEB | |
| Z-0404-2026 | Class II | Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909; | Daye (Anne's Day Ltd) | HEB | |
| Z-0403-2026 | Class II | Initiation 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-IB00180018; | Daye (Anne's Day Ltd) | HEB | |
| Z-0402-2026 | Class II | Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number... | Daye (Anne's Day Ltd) | HEB | |
| Z-0401-2026 | Class II | Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number... | Daye (Anne's Day Ltd) | HEB | |
| Z-0400-2026 | Class II | Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000; | Daye (Anne's Day Ltd) | HEB | |
| Z-0399-2026 | Class II | Initiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000; | Daye (Anne's Day Ltd) | HEB | |
| Z-0398-2026 | Class II | Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF; | Daye (Anne's Day Ltd) | HEB | |
| Z-0397-2026 | Class II | Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF; | Daye (Anne's Day Ltd) | HEB | |
| Z-0396-2026 | Class II | Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO; | Daye (Anne's Day Ltd) | HEB | |
| Z-0395-2026 | Class II | Refill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909; | Daye (Anne's Day Ltd) | HEB | |
| Z-0394-2026 | Class II | Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018; | Daye (Anne's Day Ltd) | HEB | |
| Z-0393-2026 | Class II | Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800; | Daye (Anne's Day Ltd) | HEB | |
| Z-0392-2026 | Class II | Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-REF18180000; | Daye (Anne's Day Ltd) | HEB | |
| Z-0391-2026 | Class II | Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000; | Daye (Anne's Day Ltd) | HEB | |
| Z-0390-2026 | Class II | Refill 36 Coated Regular Tampons; Model Number: FG-TMP-MM-REF36000000; | Daye (Anne's Day Ltd) | HEB | |
| Z-0389-2026 | Class II | Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF; | Daye (Anne's Day Ltd) | HEB | |
| Z-0388-2026 | Class II | Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF; | Daye (Anne's Day Ltd) | HEB | |
| Z-0387-2026 | Class II | All in One Bundle; Model Number: FG-BNDL-PC-REFAIO; | Daye (Anne's Day Ltd) | HEB | |
| Z-0386-2026 | Class II | Trial Tampon Box; Model Number: FG-TMP-REF04050504; | Daye (Anne's Day Ltd) | HEB | |
| Z-0385-2026 | Class II | 9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009; | Daye (Anne's Day Ltd) | HEB | |
| Z-0384-2026 | Class II | 9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900; | Daye (Anne's Day Ltd) | HEB | |
| Z-0383-2026 | Class II | 9 Coated Regular and 9 Coated Super Tampons; Model Number: FG-TMP-REF09090000; | Daye (Anne's Day Ltd) | HEB | |
| Z-0382-2026 | Class II | 18 Coated Super Tampons; Model Number: FG-TMP-REF00180000; | Daye (Anne's Day Ltd) | HEB | |
| Z-0381-2026 | Class II | 18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000; | Daye (Anne's Day Ltd) | HEB | |
| Z-0380-2026 | Class II | 9 Coated Regular Tampons and 9 Nude Regular Tampons; Model Number: FG-TMP-RET09000900; | Daye (Anne's Day Ltd) | HEB | |
| Z-0379-2026 | Class II | 9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009; | Daye (Anne's Day Ltd) | HEB | |
| Z-1385-2025 | Class II | Microstream Instructions for Use and Part Number used with - Product Description, REF... | Oridion Medical 1987 Ltd. | CCK | |
| Z-1384-2025 | Class II | Microstream Instructions for Use and Part Number used with - Product Description, REF... | Oridion Medical 1987 Ltd. | CCK | |
| Z-1383-2025 | Class II | Microstream Instructions for Use and Part Number used with - Product Description, REF... | Oridion Medical 1987 Ltd. | CCK |