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-1127-2021 | Class II | AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit... | Sky Medical Supplies and Equipments LLC | QKO | |
| Z-1159-2021 | Class II | Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic... | ReNovo, Inc. | HRX | |
| Z-1170-2021 | Class II | Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN... | Boston Scientific Corporation | FDI | |
| Z-1169-2021 | Class II | Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191... | Boston Scientific Corporation | FDI | |
| Z-1168-2021 | Class II | Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares... | Boston Scientific Corporation | FDI | |
| Z-1145-2021 | Class II | Tube Tracheostomy and Tube Cuff, Bivona Cuffless Neonatal/Pediatric FlexTend"... | Abbott Medical | JOH | |
| Z-1248-2021 | Class II | Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30 | Medtronic, Inc. | DQY | |
| Z-1247-2021 | Class II | Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375 | Medtronic, Inc. | DQY | |
| Z-1246-2021 | Class II | Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40 | Medtronic, Inc. | DQY | |
| Z-1245-2021 | Class II | Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35 | Medtronic, Inc. | DQY | |
| Z-1244-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 30mm Material Number: 66-230... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1243-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 22mm Material Number: 66-122... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1242-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 95mm Material Number: 66-595... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1241-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 90mm Material Number: 66-590... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1240-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 85mm Material Number: 66-585... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1239-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 80mm Material Number: 66-580... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1238-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 75mm Material Number: 66-575... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1237-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 105mm Material Number... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1236-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 100mm Material Number... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1235-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 88mm Material Number: 66-488... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1234-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 84mm Material Number: 66-484... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1233-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 80mm Material Number: 66-480... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1232-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 76mm Material Number: 66-476... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1231-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 72mm Material Number: 66-472... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1230-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 68mm Material Number: 66-468... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1229-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 64mm Material Number: 66-464... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1228-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 60mm Material Number: 66-460... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1227-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 63mm Material Number: 66-363... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1226-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 60mm Material Number: 66-360... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1225-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 57mm Material Number: 66-357... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1224-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 54mm Material Number: 66-354... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1223-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 51mm Material Number: 66-351... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1222-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 48mm Material Number: 66-348... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1221-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 45mm Material Number: 66-345... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1220-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 42mm Material Number: 66-342... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1219-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 42mm Material Number: 66-242... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1218-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 40mm Material Number: 66-240... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1217-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 38mm Material Number: 66-238... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1216-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 36mm Material Number: 66-236... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1215-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 34mm Material Number: 66-234... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1214-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 32mm Material Number: 66-232... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1213-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 28mm Material Number: 66-228... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1212-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 26mm Material Number: 66-226... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1211-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 24mm Material Number: 66-224... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1210-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 24m Material Number: 66-124... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1209-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 20mm Material Number: 66-120... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1208-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 18mm Material Number: 66-118... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1207-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 16mm Material Number: 66-116... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1206-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 14mm Material Number: 66-114... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | |
| Z-1205-2021 | Class II | CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 12mm Material Number: 66-112... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ |