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-0638-2016 | Class II | Perkin Elmer WIZARD2 1-detector,3", 1000 samples. Product Code: 2480-0010 The Wizard... | Revvity Health Sciences, Inc. | JJJ | |
| Z-0637-2016 | Class II | Perkin Elmer WIZARD2 10-detector, 1000 samples. Product Code: 2470-0200, 3470-0200. The... | Revvity Health Sciences, Inc. | JJJ | |
| Z-0636-2016 | Class II | Perkin Elmer WIZARD2 5-detector, 1000 samples Product Code: 2470-0150, 3470-0150 The... | Revvity Health Sciences, Inc. | JJJ | |
| Z-0635-2016 | Class II | Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100. The... | Revvity Health Sciences, Inc. | JJJ | |
| Z-0634-2016 | Class II | Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050. The... | Revvity Health Sciences, Inc. | JJJ | |
| Z-0633-2016 | Class II | Perkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard gamma... | Revvity Health Sciences, Inc. | JJJ | |
| Z-0632-2016 | Class II | Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard gamma... | Revvity Health Sciences, Inc. | JJJ | |
| Z-0201-2019 | Class II | GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2. | GE Healthcare | LNH | |
| Z-0553-2016 | Class II | GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Usage The 3.0T... | GE Healthcare | MOS | |
| Z-0662-2016 | Class II | Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR... | Innovasis, Inc | NKB | |
| Z-0467-2016 | Class II | MAGNETOM systems, magnetic resonance diagnostic devices (MRDD). | Siemens Medical Solutions USA, Inc. | LNH | |
| Z-1180-2016 | Class II | Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and... | STERIS Corporation | MED | |
| Z-0644-2016 | Class II | Model NuCARTGN. The NuCART is a mobile display and image management platform used in... | CompView Medical, LLC | LMD | |
| Z-0480-2016 | Class II | Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026... | Synaptive Medical Inc | HAW | |
| Z-0653-2022 | Class II | Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe... | Abbott Medical | FRN | |
| Z-2683-2016 | Class II | MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600... | Teleflex Medical | BYD | |
| Z-2374-2016 | Class II | Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture... | Teleflex Medical | BYD | |
| Z-1081-2016 | Class II | Stryker Position Pro Mattress. Mattress, Air Flotation, Alternating... | Stryker Medical | FNM | |
| Z-0571-2016 | Class II | BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 4.0 mL (Lavender) BD Hemogard... | Becton Dickinson & Co | JKA | |
| Z-0570-2016 | Class II | BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Tan) BD Hemogard... | Becton Dickinson & Co | JKA | |
| Z-0569-2016 | Class II | BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Lavender) BD Hemogard... | Becton Dickinson & Co | JKA | |
| Z-0568-2016 | Class II | BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard... | Becton Dickinson & Co | JKA | |
| Z-0567-2016 | Class II | BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard... | Becton Dickinson & Co | JKA | |
| Z-0602-2016 | Class II | Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE... | Ethicon, Inc | PFJ | |
| Z-0762-2016 | Class II | VS300 radiographic Cassette Holder or Wall Stand. For use in radiology department. | Del Medical, Inc. | IXY | |
| Z-0761-2016 | Class II | VS200 radiographic Cassette Holder or Wall Stand. For use in radiology department. | Del Medical, Inc. | IXY | |
| Z-0590-2016 | Class II | NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01... | Zimmer Manufacturing B.V. | JWH | |
| Z-0866-2016 | Class II | PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product... | Gsi Group Inc | DSF | |
| Z-0655-2016 | Class II | Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display... | Skytron, LLC | FQO | |
| Z-0472-2016 | Class II | Green Mamba Suture Passer | Zimmer GmbH | HWQ | |
| Z-0471-2016 | Class II | Black Mamba Suture Passer | Zimmer GmbH | HWQ | |
| Z-0822-2016 | Class II | Best Practice Kits containing certain production lots of Endo GIA Ultra Universal Stapler... | Medtronic, Inc. | GDW | |
| Z-0821-2016 | Class II | Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL Product... | Medtronic, Inc. | GDW | |
| Z-0820-2016 | Class II | Covidien Endo GIA Ultra Universal Standard Stapler Handle Ref: EGIAUSTND Product... | Medtronic, Inc. | GDW | |
| Z-0819-2016 | Class II | Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHORT Product... | Medtronic, Inc. | GDW | |
| Z-0449-2016 | Class II | Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number... | Zimmer Manufacturing B.V. | JWH | |
| Z-0704-2022 | Class II | QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1... | Microbiologics, Inc. | JTR | |
| Z-0703-2022 | Class II | QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets include... | Microbiologics, Inc. | JTR | |
| Z-0732-2016 | Class II | PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery. | JosNoe Medical Inc | NWV | |
| Z-0601-2016 | Class II | 3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF... | 3M Company | FMP | |
| Z-0562-2016 | Class II | MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 MicroScan Pos... | Siemens Healthcare Diagnostics Inc. | LTT | |
| Z-0561-2016 | Class II | MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202 MicroScan Pos... | Siemens Healthcare Diagnostics Inc. | LTT | |
| Z-0560-2016 | Class II | MicroScan Pos Combo Panel Type 34, Part No. B1017-214 MicroScan Pos (Positive) panels... | Siemens Healthcare Diagnostics Inc. | LTT | |
| Z-0559-2016 | Class II | MicroScan Pos Combo Panel Type 33, Part No. B1017-211 MicroScan Pos (Positive) panels... | Siemens Healthcare Diagnostics Inc. | LTT | |
| Z-0558-2016 | Class II | MicroScan Pos Combo Panel Type 21, Part No. B1017-201 MicroScan Pos (Positive) panels... | Siemens Healthcare Diagnostics Inc. | LTT | |
| Z-0434-2016 | Class II | UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Part No... | Siemens Healthcare Diagnostics Inc. | GKZ | |
| Z-0433-2016 | Class II | UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No... | Siemens Healthcare Diagnostics Inc. | GKZ | |
| Z-0432-2016 | Class II | UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No... | Siemens Healthcare Diagnostics Inc. | GKZ | |
| Z-0585-2016 | Class II | SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer... | Synthes (USA) Products LLC | HTO | |
| Z-0436-2016 | Class I | Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500... | Draeger, Inc. | CBK |