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-2663-2017 | Class II | EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01 | Exactech, Inc. | HTX | |
| Z-2662-2017 | Class II | Logic Fit Tibial Tamp Head | Exactech, Inc. | LXH | |
| Z-3036-2017 | Class II | Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating... | Samsung HME America, Inc. | KPR | |
| Z-0073-2018 | Class II | Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model... | Northgate Technologies Inc. | FFK | |
| Z-2601-2017 | Class II | Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI. | Merge Healthcare Incorporated | LLZ | |
| Z-2620-2017 | Class II | Merge OrthoPACS software. | Merge Healthcare Incorporated | LLZ | |
| Z-2648-2017 | Class II | Eleos Limb Salvage System Segmental Stem, Canal Filling, Diameter 20Mm, Length 120Mm... | Onkos Surgical, Inc. | KRO | |
| Z-2647-2017 | Class II | Eleos Limb Salvage System Segmental Stem, Canal Filling, Diameter 20Mm, Length 120Mm... | Onkos Surgical, Inc. | KRO | |
| Z-0176-2018 | Class II | Dimension Vista Protein 1 Control H, PROT 1 CON H, Siemens Material Number (SMN)... | Siemens Healthcare Diagnostics Inc. | CHN | |
| Z-0175-2018 | Class II | Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN)... | Siemens Healthcare Diagnostics Inc. | CHN | |
| Z-0174-2018 | Class II | Dimension Vista Protein 1 Control, PROT 1 CON L, Siemens Material Number (SMN) 10445919... | Siemens Healthcare Diagnostics Inc. | CHN | |
| Z-0173-2018 | Class II | Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664... | Siemens Healthcare Diagnostics Inc. | CHN | |
| Z-3068-2017 | Class II | Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in... | PENTAX of America, Inc. | ODG | |
| Z-3067-2017 | Class II | Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in... | PENTAX of America, Inc. | ODG | |
| Z-2655-2017 | Class II | SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for... | Shimadzu Medical Systems | KPR | |
| Z-2654-2017 | Class II | SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system | Shimadzu Medical Systems | KPR | |
| Z-2653-2017 | Class II | SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number... | Shimadzu Medical Systems | KPR | |
| Z-2646-2017 | Class II | Eleos Limb Salvage System Segmental Stem, Canal Filling, Diameter 18Mm, Length 120Mm... | Onkos Surgical, Inc. | KRO | |
| Z-2697-2017 | Class II | Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of... | Elekta Limited | IWB | |
| Z-2226-2017 | Class I | Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The... | Magellan Diagnostics, Inc. | DOF | |
| Z-2225-2017 | Class I | Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare... | Magellan Diagnostics, Inc. | DOF | |
| Z-0490-2018 | Class II | Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 701066990. Used... | Maquet Cardiovascular Us Sales, LLC | DWE | |
| Z-0412-2018 | Class II | SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line... | MicroAire Surgical Instruments, LLC | HTW | |
| Z-0410-2018 | Class II | TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE | SOMATEX Medical Technologies GmbH | NEU | |
| Z-3203-2017 | Class II | Drill Bit Quick-Connect 3.2 mm Diameter 195 mm Length, Item Number/EDI 00480619532... | Zimmer GmbH | HWE | |
| Z-3202-2017 | Class II | Drill Bit Quick-Connect 4.5 mm Diameter 145 mm Length, Item Number/EDI 00480614545... | Zimmer GmbH | HWE | |
| Z-3201-2017 | Class II | Zimmer Natural Nail System Freehand Drill 4.3 mm Diameter 152.5 mm Length, Item... | Zimmer GmbH | HWE | |
| Z-3200-2017 | Class II | Drill Bit Quick-Connect Calibrated 3-Fluted 2.5 mm Diameter 230 mm Length, Item... | Zimmer GmbH | HWE | |
| Z-3199-2017 | Class II | Drill Bit Quick-Connect 3-Fluted 4.5 mm Diameter 195 mm Length, Item Number/EDI... | Zimmer GmbH | HWE | |
| Z-3198-2017 | Class II | Drill bit Quick-Connect 3-Fluted 2.5 mm Diameter 180 mm Length, Item Number/EDI... | Zimmer GmbH | HWE | |
| Z-3197-2017 | Class II | Drill Bit Quick-Connect 3.2 mm Diameter 145 mm Length, Item Number/EDI 00480614532... | Zimmer GmbH | HWE | |
| Z-3196-2017 | Class II | Drill Bit Quick-Connect 3.5 mm Diameter 110 mm Length, Item Number/EDI 00480611035... | Zimmer GmbH | HWE | |
| Z-3195-2017 | Class II | Drill Bit Quick-Connect 2.5 mm Diameter 110 mm Length, Item Number/EDI 00480611025... | Zimmer GmbH | HWE | |
| Z-3194-2017 | Class II | Drill Bit Quick-Connect 2.7 mm Diameter 100 mm Length, Item Number/EDI 00480610027... | Zimmer GmbH | HWE | |
| Z-3193-2017 | Class II | Drill Bit Quick-Connect 2.0 mm Diameter 100 mm Length, Item Number/EDI 00480610020... | Zimmer GmbH | HWE | |
| Z-3192-2017 | Class II | Drill Bit Quick-Connect 1.5 mm Diameter 85 mm Length, Item Number/EDI 00480608515... | Zimmer GmbH | HWE | |
| Z-3191-2017 | Class II | Drill Bit Jacobs Chuck 3.2 mm Diameter 130 mm Length, Item Number/EDI 00480513032... | Zimmer GmbH | HWE | |
| Z-3190-2017 | Class II | Drill Bit Jacobs Chuck 2.0 mm Diameter 85 mm Length, Item Number/EDI 00480508520... | Zimmer GmbH | HWE | |
| Z-3189-2017 | Class II | Zimmer Natural Nail System Calibrated Drill Short 4.9 mm, Item Number/EDI 00249006449... | Zimmer GmbH | HWE | |
| Z-3188-2017 | Class II | ECT Internal Fracture Fixation Quick-Connect Drill 4.0 mm Diameter 20cm Length, Item... | Zimmer GmbH | HWE | |
| Z-3187-2017 | Class II | ECT Internal Fracture Fixation Quick-Connect Drill 3.5 mm Diameter 11 cm Length, Item... | Zimmer GmbH | HWE | |
| Z-3186-2017 | Class II | ECT Internal Fracture Fixation Quick-Connect Drill 2.7 mm Diameter 10 cm Length, Item... | Zimmer GmbH | HWE | |
| Z-3185-2017 | Class II | ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 12.5 cm Length, Item... | Zimmer GmbH | HWE | |
| Z-3184-2017 | Class II | ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 11 cm Length, Item... | Zimmer GmbH | HWE | |
| Z-3183-2017 | Class II | ECT Internal Fracture Fixation Quick-Connect Drill 2.0 mm Diameter 12.5 cm Length, Item... | Zimmer GmbH | HWE | |
| Z-3182-2017 | Class II | ECT Internal Fracture Fixation Quick-Connect Drill 2.0 mm Diameter 10 cm Length, Item... | Zimmer GmbH | HWE | |
| Z-3181-2017 | Class II | Zimmer Periarticular Locking Plate System Drill Standard 2.7 mm Diameter, Item... | Zimmer GmbH | HWE | |
| Z-3180-2017 | Class II | Zimmer Periarticular Locking Plate System Drill Standard 2.0 mm Diameter, Item Number/EDI... | Zimmer GmbH | HWE | |
| Z-3179-2017 | Class II | Zimmer Periarticular Locking Plate System Cannulated Drill Standard Quick-Connect 2.7 mm... | Zimmer GmbH | HWE | |
| Z-3178-2017 | Class II | Zimmer Periarticular Locking Plate System, Locking Screw Tap Standard Quick-Connect 3.5... | Zimmer GmbH | HWE |