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-1680-2023 | Class II | DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in... | DePuy Mitek, Inc. | MAI | |
| Z-1679-2023 | Class II | DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in... | DePuy Mitek, Inc. | MAI | |
| Z-1678-2023 | Class II | DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone... | DePuy Mitek, Inc. | MAI | |
| Z-1677-2023 | Class II | DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone... | DePuy Mitek, Inc. | MAI | |
| Z-1625-2023 | Class II | Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149... | Philips Headquarters Cambridge | JAK | |
| Z-1624-2023 | Class II | Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148... | Philips Headquarters Cambridge | JAK | |
| Z-1623-2023 | Class II | Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS) | Philips Headquarters Cambridge | JAK | |
| Z-1622-2023 | Class II | Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144 | Philips Headquarters Cambridge | JAK | |
| Z-1611-2023 | Class II | Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for... | Teleflex Medical | MGB | |
| Z-1503-2023 | Class II | Ultraview SL (UVSL) Command Module, Model 91496 | GE Healthcare | DSI | |
| Z-1666-2023 | Class I | StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems | Medtronic Navigation, Inc | HAW | |
| Z-1614-2023 | Class II | Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an... | Integra LifeSciences Corporation | GWM | |
| Z-1630-2023 | Class I | StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with... | Medtronic Navigation, Inc | HAW | |
| Z-1564-2023 | Class II | Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF... | Bard Peripheral Vascular Inc | KNW | |
| Z-2580-2023 | Class II | Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining... | Keystone Industries | EBI | |
| Z-2270-2023 | Class II | Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO... | Shimadzu Corporation Medical Systems Division | IYB | |
| Z-1467-2023 | Class II | stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation | Wright Medical Technology Inc | HRS | |
| Z-1466-2023 | Class II | stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation | Wright Medical Technology Inc | HRS | |
| Z-1595-2023 | Class II | Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062 | STERIS Corporation | MEC | |
| Z-1648-2023 | Class II | Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System... | Cytrellis Biosystems, Inc. | QAI | |
| Z-1428-2023 | Class I | Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers... | Cook Incorporated | JOH | |
| Z-1427-2023 | Class I | Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers... | Cook Incorporated | JOH | |
| Z-1690-2023 | Class II | Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic... | Medtronic, Inc. | OHD | |
| Z-1604-2023 | Class II | ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental... | Hiossen, Inc. | DZE | |
| Z-1991-2023 | Class II | Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, REF... | Karl Storz Endoscopy-America, Inc. | KCT | |
| Z-1675-2023 | Class II | Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil. | Elekta Limited | IYE | |
| Z-1610-2023 | Class II | 3M Attest Steam Chemical Integrators, REF 1243B | 3M Company | JOJ | |
| Z-1609-2023 | Class II | 3M Attest Steam Chemical Integrators, REF 1243A | 3M Company | JOJ | |
| Z-1600-2023 | Class II | Fisher Wallace Stimulator Models FW-100 and FW-200 | FISHER WALLACE LABORATORIES Inc | QJQ | |
| Z-0906-2025 | Class II | BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main... | CareFusion 303, Inc | BRY | |
| Z-1977-2023 | Class II | MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software. | Illumina, Inc. | PFF | |
| Z-1976-2023 | Class II | NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software | Illumina, Inc. | PFF | |
| Z-1981-2023 | Class II | KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA... | Karl Storz Endoscopy-America, Inc. | KCT | |
| Z-1632-2023 | Class II | Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica CH Toxicology Calibrator (TOX... | Siemens Healthcare Diagnostics Inc. | JLX | |
| Z-1631-2023 | Class II | ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of... | Siemens Healthcare Diagnostics Inc. | JLX | |
| Z-1599-2023 | Class II | UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis | Siemens Healthcare Diagnostics Inc. | KQO | |
| Z-1608-2023 | Class II | Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL | Siemens Healthcare Diagnostics Inc. | KHS | |
| Z-1607-2023 | Class II | Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL | Siemens Healthcare Diagnostics Inc. | KHS | |
| Z-1606-2023 | Class II | Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL | Siemens Healthcare Diagnostics Inc. | KHS | |
| Z-1593-2023 | Class II | WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020... | Boston Scientific Corporation | DTL | |
| Z-1592-2023 | Class II | WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020... | Boston Scientific Corporation | DTL | |
| Z-1579-2023 | Class II | BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main... | CareFusion 303, Inc | BRY | |
| Z-1598-2023 | Class II | DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic... | Siemens Healthcare Diagnostics Inc. | KQO | |
| Z-1597-2023 | Class II | DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic... | Siemens Healthcare Diagnostics Inc. | KQO | |
| Z-1596-2023 | Class II | iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and... | Siemens Healthcare Diagnostics Inc. | KQO | |
| Z-1582-2023 | Class II | DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code... | Abbott Medical | BZA | |
| Z-1581-2023 | Class II | DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code... | Abbott Medical | BZA | |
| Z-1580-2023 | Class II | DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991)... | Abbott Medical | BZA | |
| Z-1472-2023 | Class II | Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry... | Draeger Medical Systems, Inc. | MHX | |
| Z-1471-2023 | Class II | Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and... | Draeger Medical Systems, Inc. | MHX |