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-0025-2019 | Class II | CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02 | Oridion Medical 1987 Ltd. | CCK | |
| Z-0024-2019 | Class II | CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657 | Oridion Medical 1987 Ltd. | CCK | |
| Z-0023-2019 | Class II | CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0022-2019 | Class II | CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0021-2019 | Class II | CAPNOSTREAM 20P (US) N, Part Number CS08651-01 | Oridion Medical 1987 Ltd. | CCK | |
| Z-0020-2019 | Class II | CAPNOSTREAM 20 (US) N, Part Number CS08651 | Oridion Medical 1987 Ltd. | DQA | |
| Z-0006-2019 | Class I | ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile EO, REF... | Endologix LLC | MIH | |
| Z-1384-2019 | Class I | UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product Usage: Note... | Siemens Healthcare Diagnostics Inc. | GKZ | |
| Z-1383-2019 | Class I | UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Product Usage: Note... | Siemens Healthcare Diagnostics Inc. | GKZ | |
| Z-1382-2019 | Class I | UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, B24802... | Siemens Healthcare Diagnostics Inc. | GKZ | |
| Z-0868-2019 | Class II | Vitality Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation... | Highridge Medical, LLC | KWQ | |
| Z-0867-2019 | Class II | Vitality Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (non-sterile)... | Highridge Medical, LLC | KWP | |
| Z-0866-2019 | Class II | Vitality Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile)... | Highridge Medical, LLC | NKB | |
| Z-3246-2018 | Class II | Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 Product Usage... | Zimmer GmbH | HSB | |
| Z-3197-2018 | Class II | ARROW Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DRF | |
| Z-2947-2018 | Class II | CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO | CIVCO Medical Instruments Co., Inc. | ITX | |
| Z-2946-2018 | Class II | CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO | CIVCO Medical Instruments Co., Inc. | ITX | |
| Z-3190-2018 | Class II | ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000 | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-3189-2018 | Class II | Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-1676-2020 | Class II | ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for bone or... | Synvasive Technology, Inc. | GFA | |
| Z-0973-2019 | Class II | Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic... | Stryker Sustainability Solutions | HRX | |
| Z-2953-2018 | Class II | Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex... | Sysmex America, Inc. | KQC | |
| Z-2357-2019 | Class II | Microdot Xtra blood glucose test strips | Cambridge Sensors Limited | NBW | |
| Z-3240-2018 | Class II | Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002... | Stryker Corp. | KTT | |
| Z-2959-2018 | Class II | AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems The... | STERIS Corporation | MLR | |
| Z-2958-2018 | Class II | Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product... | Medtronic, Inc. | OLW | |
| Z-1794-2020 | Class II | Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product... | Alcon Laboratories | HQC | |
| Z-0224-2020 | Class II | HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part... | Hycor Biomedical | DHB | |
| Z-0477-2019 | Class II | Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction... | The Binding Site Group Ltd. | CFN | |
| Z-3183-2018 | Class II | PR1000 Pivot Rehab Bed AC powered adjustable bed. | Med-Mizer, Inc. | FNL | |
| Z-0110-2020 | Class II | YUKON Polyaxial Screws (3.5 X 12 mm, Owning Site: Leesburg USA 3.5 X 14 mm, 3.5 X 32 mm... | K2M, Inc | NKG | |
| Z-0117-2019 | Class II | Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro... | Siemens Healthcare Diagnostics Inc. | JHS | |
| Z-0116-2019 | Class II | Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic... | Siemens Healthcare Diagnostics Inc. | JHS | |
| Z-0115-2019 | Class II | ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: For in vitro... | Siemens Healthcare Diagnostics Inc. | JHS | |
| Z-0114-2019 | Class II | ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro... | Siemens Healthcare Diagnostics Inc. | JHS | |
| Z-0113-2019 | Class II | ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic... | Siemens Healthcare Diagnostics Inc. | JHS | |
| Z-0076-2019 | Class II | BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC... | Boston Scientific Corporation | LJT | |
| Z-2994-2018 | Class II | Diagnostica Stago STA Noplastine CI, 10 ml vial. In-Vitro Diagnostic for determination... | Diagnostica Stago, Inc. | GJS | |
| Z-2993-2018 | Class II | Diagnostica Stago STA Noplastine CI Plus, 10 ml vial. In-Vitro Diagnostic for... | Diagnostica Stago, Inc. | GJS | |
| Z-2956-2018 | Class II | GE 9100c NXT anesthesia systems | GE Medical Systems China Co., Ltd. | BSZ | |
| Z-2955-2018 | Class II | GE Carestation 30 anesthesia systems | GE Medical Systems China Co., Ltd. | BSZ | |
| Z-2954-2018 | Class II | GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems | GE Medical Systems China Co., Ltd. | BSZ | |
| Z-2925-2018 | Class II | Stryker Mako Vizadisc Hip Procedure Tracking Kit | Mako Surgical Corp. | OLO | |
| Z-2924-2018 | Class II | Stryker Mako Vizadisc Knee Procedure Tracking Kit | Mako Surgical Corp. | OLO | |
| Z-0383-2019 | Class II | EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1... | Qiagen | JJH | |
| Z-3241-2018 | Class II | Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14... | Reckitt Benckiser LLC | MOL | |
| Z-3187-2018 | Class II | Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or... | Tecan U.S. | JQW | |
| Z-2916-2018 | Class II | Johnson and Johnson Vision Care 1-Day ACUVUE MOIST Daily Wear, 8.5 Base Curve, -3.25... | Johnson & Johnson Vision Care, Inc. | LPL | |
| Z-3177-2018 | Class II | Gentle Thread PLGA Full Thread Interference Screw, 10x30mm, Item Number 905629 | Zimmer GmbH | HWC | |
| Z-3176-2018 | Class II | Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612 | Zimmer GmbH | HWC |