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-2220-2017 | Class II | Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T... | IBA Dosimetry GmbH | IYE | |
| Z-0254-2018 | Class II | enGen Track System with TCAutomation Software Version 4.2 | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-2160-2017 | Class II | Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC... | Howmedica Osteonics Corp | KTT | |
| Z-2216-2017 | Class II | Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The product is... | Zimmer GmbH | KWS | |
| Z-2151-2017 | Class I | Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS is a... | Abbott Vascular | PNY | |
| Z-0719-2018 | Class II | MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes... | Medistim ASA | DPW | |
| Z-0070-2018 | Class II | Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee... | Zimmer GmbH | KRO | |
| Z-2538-2017 | Class II | Endoscopic Introducer/Extractor | Cook Incorporated | FZX | |
| Z-2537-2017 | Class II | Clarke-Reich Laparoscopic Knot Pusher | Cook Incorporated | NWV | |
| Z-2536-2017 | Class II | Stamey Needle | Cook Incorporated | GEJ | |
| Z-2535-2017 | Class II | Pereyra Ligature Carrier 75 | Cook Incorporated | GEJ | |
| Z-2534-2017 | Class II | Pereyra-Raz Ligature Carrier | Cook Incorporated | GEJ | |
| Z-2224-2017 | Class I | Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter... | Vascular Solutions LLC | DQY | |
| Z-2120-2017 | Class II | StatLock IV Premium Catheter Stabilization Device, product code IV0570. sterile... | Bard Access Systems, Inc. | KMK | |
| Z-2218-2017 | Class II | Assist Bed Rail - 6632 | Invacare GmbH | N/A | |
| Z-2095-2017 | Class II | ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative... | bioMerieux, Inc. | JWY | |
| Z-2769-2017 | Class II | Diagnostics Ultrasound System Ultrasounds System Sonimage HS1 | Konica Minolta, Inc. | IYN | |
| Z-2321-2017 | Class II | Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is... | Orthopediatrics Corp | OWI | |
| Z-2158-2017 | Class II | UniCel DxH 600 Coulter Cellular Analysis System, Catalog No. B23858. | Siemens Healthcare Diagnostics Inc. | GKZ | |
| Z-2157-2017 | Class II | UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802... | Siemens Healthcare Diagnostics Inc. | GKZ | |
| Z-2124-2017 | Class II | Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used... | Siemens Healthcare Diagnostics Inc. | DCF | |
| Z-2110-2017 | Class II | Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts' | Molnlycke Health Care | FZW | |
| Z-2061-2017 | Class I | Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616... | Respironics, Inc. | MNT | |
| Z-2055-2017 | Class II | Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc... | Greatbatch Medical | HTQ | |
| Z-2656-2017 | Class II | Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner... | JAS Diagnostics/Drew Scientific | GKZ | |
| Z-2248-2017 | Class II | Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights... | STRYKER Communications, Inc. | KZF | |
| Z-2150-2017 | Class II | Jackson-Pratt Silicone Flat Drain, 10mm Full W/Trocar. Sterile, Rx Only. For Single Use... | Medtronic, Inc. | GCY | |
| Z-2149-2017 | Class II | Jackson-Pratt Silicone Flat Drain, 7mm Full W/Trocar. Sterile, Rx Only. For Single Use... | Medtronic, Inc. | GCY | |
| Z-2148-2017 | Class II | Jackson-Pratt Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use Only... | Medtronic, Inc. | GCY | |
| Z-2147-2017 | Class II | Jackson-Pratt Silicone Round Drain, 15FR. Sterile, Rx Only. For Single Use Only... | Medtronic, Inc. | GCY | |
| Z-2146-2017 | Class II | Jackson-Pratt Silicone Round Drain, 10FR. Sterile, Rx Only. For Single Use Only... | Medtronic, Inc. | GBX | |
| Z-2145-2017 | Class II | Jackson-Pratt Silicone Round Drain, 7FR. Sterile, Rx Only. For Single Use Only... | Medtronic, Inc. | GBX | |
| Z-2144-2017 | Class II | Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For Single Use... | Medtronic, Inc. | GCY | |
| Z-2143-2017 | Class II | Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts. Sterile, Rx Only. For Single Use... | Medtronic, Inc. | GCY | |
| Z-2142-2017 | Class II | Jackson-Pratt Silicone Flat Drain, 10mm, 3/4 Ducts. Sterile, Rx Only. For Single Use... | Medtronic, Inc. | GCY | |
| Z-2141-2017 | Class II | Jackson-Pratt Silicone Flat Drain, 7mm, 3/4 Ducts. Sterile, Rx Only. For Single Use... | Medtronic, Inc. | GCY | |
| Z-2140-2017 | Class II | Jackson-Pratt PVC Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only... | Medtronic, Inc. | GCY | |
| Z-2139-2017 | Class II | Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single... | Medtronic, Inc. | GCY | |
| Z-2138-2017 | Class II | Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single... | Medtronic, Inc. | GCY | |
| Z-2137-2017 | Class II | Jackson-Pratt Hemaduct Silicone Round Drain, 19FR W/15FR Trocar. Sterile, Rx Only. For... | Medtronic, Inc. | GBX | |
| Z-2136-2017 | Class II | Jackson-Pratt Hemaduct Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use... | Medtronic, Inc. | GBX | |
| Z-2135-2017 | Class II | Jackson-Pratt Hemaduct Silicone Round Drain, 15FR W/15FR Trocar. Sterile, Rx Only. For... | Medtronic, Inc. | GBX | |
| Z-2134-2017 | Class II | Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/10FR Trocar. Sterile, Rx Only. For... | Medtronic, Inc. | GBX | |
| Z-2133-2017 | Class II | Jackson-Pratt Hemaduct Silicone Flat Drain, 10mm, Full Ducts W/15FR Trocar. Sterile, Rx... | Medtronic, Inc. | GBX | |
| Z-2132-2017 | Class II | Jackson-Pratt Hemaduct Silicone Flat Drain. Sterile, Rx Only. For Single Use Only... | Medtronic, Inc. | GBX | |
| Z-2131-2017 | Class II | Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR. Sterile, Rx Only. For... | Medtronic, Inc. | GBX | |
| Z-2130-2017 | Class II | INFANT 20/BX, Sterile, Single use Product Usage: Catheter Connector/Accessory | Teleflex Medical | GCD | |
| Z-2129-2017 | Class II | PE CONNECTOR 5 IN 1 20/BX, Sterile, Single use, Product Usage: Catheter... | Teleflex Medical | GCD | |
| Z-2128-2017 | Class II | PE CONNECTOR 3/8 Y 20/BX, Sterile, Single use, Product Usage: Catheter... | Teleflex Medical | GCD | |
| Z-2127-2017 | Class II | PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use, Product Usage: Catheter... | Teleflex Medical | GCD |