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-1904-2018 | Class II | smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF... | Smith & Nephew, Inc. | JWH | |
| Z-1929-2018 | Class II | Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile... | Edwards Lifesciences LLC | DXC | |
| Z-2426-2018 | Class II | Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog... | Stryker Sustainability Solutions | NLH | |
| Z-2388-2018 | Class II | Discovery IGS 740 Interventional Fluoroscopic X-ray Systems | GE Medical Systems SCS | OWB | |
| Z-2387-2018 | Class II | Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems | GE Medical Systems SCS | OWB | |
| Z-2386-2018 | Class II | Discovery IGS 730 Interventional Fluoroscopic X-ray Systems | GE Medical Systems SCS | OWB | |
| Z-2531-2018 | Class II | Access Hi-Low Exam Tables, Model 6501-XX | The Brewer Company LLC | LGX | |
| Z-1894-2018 | Class II | iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY... | Siemens Healthcare Diagnostics Inc. | KQO | |
| Z-1756-2018 | Class II | Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The... | Cook Incorporated | DTL | |
| Z-1755-2018 | Class II | Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-M-FM Product Usage: The... | Cook Incorporated | DTL | |
| Z-1754-2018 | Class II | Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM Product Usage: The... | Cook Incorporated | DTL | |
| Z-1753-2018 | Class II | Connecting Tube - Female to Male Luer Lock, HPCT8.8-30-M-FM Product Usage: The... | Cook Incorporated | DTL | |
| Z-1752-2018 | Class II | Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS Product Usage: The... | Cook Incorporated | DTL | |
| Z-1751-2018 | Class II | Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM Product Usage: The... | Cook Incorporated | DTL | |
| Z-1381-2018 | Class II | Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number... | Zimmer GmbH | LZO | |
| Z-2290-2018 | Class II | RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 Product... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-2277-2018 | Class II | Ingenuity Core128/Elite China 728324 | Philips North America LLC | JAK | |
| Z-2276-2018 | Class II | Ingenuity TF PET/CT 882442 | Philips North America LLC | KPS | |
| Z-2275-2018 | Class II | Ingenuity Core128 728323 | Philips North America LLC | JAK | |
| Z-2274-2018 | Class II | Philips Ingenuity Core 728321 | Philips North America LLC | JAK | |
| Z-2273-2018 | Class II | Brilliance Big Bore Radiology 728244 | Philips North America LLC | JAK | |
| Z-1813-2018 | Class II | Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724... | Draeger Medical Systems, Inc. | MHX | |
| Z-1464-2018 | Class II | Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve... | Ace Surgical Supply Co., Inc. | EMO | |
| Z-1546-2018 | Class II | Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF... | Medtronic, Inc. | GCX | |
| Z-1739-2018 | Class II | Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment... | Zimmer GmbH | HWC | |
| Z-1738-2018 | Class II | Gentle Threads, Interference Screw; Model No. 905608, for soft tissue reattachment... | Zimmer GmbH | HWC | |
| Z-1737-2018 | Class II | Gentle Threads, Interference Screw; Model No. 905607, for soft tissue reattachment... | Zimmer GmbH | HWC | |
| Z-1736-2018 | Class II | Gentle Threads, Interference Screw; Model No. 905605, for soft tissue reattachment... | Zimmer GmbH | HWC | |
| Z-1735-2018 | Class II | Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment... | Zimmer GmbH | HWC | |
| Z-1734-2018 | Class II | Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment... | Zimmer GmbH | HWC | |
| Z-2339-2018 | Class II | Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non Sterile | Trilliant Surgical LLC | MDM | |
| Z-2338-2018 | Class II | Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile | Trilliant Surgical LLC | MDM | |
| Z-2062-2018 | Class II | ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800... | Siemens Healthcare Diagnostics Inc. | CDQ | |
| Z-1778-2018 | Class II | Syngo.Via VB20A model 1049610 | Siemens Medical Solutions USA, Inc. | LLZ | |
| Z-1403-2018 | Class II | Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY... | Teleflex Medical | BZA | |
| Z-1757-2018 | Class II | AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail... | TORNIER Inc. | HTW | |
| Z-1889-2018 | Class II | 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm... | Ethicon Endo-Surgery Inc | GCJ | |
| Z-1888-2018 | Class II | 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm... | Ethicon Endo-Surgery Inc | GCJ | |
| Z-1887-2018 | Class II | 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm... | Ethicon Endo-Surgery Inc | GCJ | |
| Z-1886-2018 | Class II | 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm... | Ethicon Endo-Surgery Inc | GCJ | |
| Z-1885-2018 | Class II | 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm... | Ethicon Endo-Surgery Inc | GCJ | |
| Z-1804-2018 | Class II | BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3%... | Siemens Healthcare Diagnostics Inc. | JWY | |
| Z-1609-2018 | Class II | MultiDiagnostic-Eleva with Flat Detector 708035 As a multifunctional universal imaging... | Philips Medical Systems Nederland B.V. | KPR | |
| Z-1608-2018 | Class II | MultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional universal imaging... | Philips Medical Systems Nederland B.V. | KPR | |
| Z-1607-2018 | Class II | Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As a... | Philips Medical Systems Nederland B.V. | KPR | |
| Z-1606-2018 | Class II | Mutlidiagnost-Eleva with Flat Detector 708034 As a multifunctional universal imaging... | Philips Medical Systems Nederland B.V. | KPR | |
| Z-1605-2018 | Class II | MultiDiagnost Eleva 708036 As a multifunctional universal imaging application system... | Philips Medical Systems Nederland B.V. | IZI | |
| Z-1604-2018 | Class II | 708033 URODiagnost As a multifunctional universal imaging application system, General... | Philips Medical Systems Nederland B.V. | IXR | |
| Z-1603-2018 | Class II | MultiDim Eleva 708032 As a multifunctional universal imaging application system... | Philips Medical Systems Nederland B.V. | KPR | |
| Z-1476-2018 | Class II | ZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm... | Zimmer GmbH | LXH |