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-1994-2021 | Class II | 5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit... | Bard Access Systems, Inc. | LJS | |
| Z-1991-2021 | Class II | 5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc... | Bard Access Systems, Inc. | LJS | |
| Z-1951-2021 | Class II | LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left... | Smith & Nephew, Inc. | JWH | |
| Z-1863-2021 | Class I | GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860 | Vero Biotech Inc. | MRN | |
| Z-2101-2021 | Class II | Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN... | Howmedica Osteonics Corp | NDN | |
| Z-2100-2021 | Class II | Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN... | Howmedica Osteonics Corp | NDN | |
| Z-2014-2021 | Class II | The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an... | Siemens Healthcare Diagnostics Inc. | JGS | |
| Z-0146-2022 | Class II | Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749 | Adria SRL. | HRX | |
| Z-0145-2022 | Class II | Herniatome, 17G x 15cm, Lumbar Type, Model Number 5091745 | Adria SRL. | HRX | |
| Z-0144-2022 | Class II | Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 5091715 | Adria SRL. | HRX | |
| Z-2096-2021 | Class II | AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive... | Mediana Co., Ltd. | DXN | |
| Z-2134-2021 | Class II | CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A... | Cytocell Limited | MVU | |
| Z-1798-2021 | Class I | JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x... | Abbott Medical | MEG | |
| Z-2076-2021 | Class II | Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only | Medtronic, Inc. | MXD | |
| Z-1846-2021 | Class II | ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2... | Brainlab, Inc. | IYE | |
| Z-1993-2021 | Class II | PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage... | Abbott Medical | JOH | |
| Z-1834-2021 | Class I | DeRoyal Angio Cath Removal Tray, REF 89-9936.02 | DeRoyal Industries, Inc. | LRO | |
| Z-1833-2021 | Class I | DeRoyal Heart Cath Procedure Pack, REF 89-6556.08 | DeRoyal Industries, Inc. | LRO | |
| Z-1832-2021 | Class I | DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06 | DeRoyal Industries, Inc. | LRO | |
| Z-2028-2021 | Class II | Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of... | Siemens Healthcare Diagnostics Inc. | JLW | |
| Z-2027-2021 | Class II | Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of... | Siemens Healthcare Diagnostics Inc. | JLW | |
| Z-2026-2021 | Class II | Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of... | Siemens Healthcare Diagnostics Inc. | JGS | |
| Z-0038-2022 | Class II | CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE... | CardioQuip | DWC | |
| Z-0037-2022 | Class II | CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI... | CardioQuip | DWC | |
| Z-0036-2022 | Class II | CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI... | CardioQuip | DWC | |
| Z-0035-2022 | Class II | CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103 | CardioQuip | DWC | |
| Z-2293-2021 | Class II | Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm... | W. L. Gore & Associates, Inc. | DSY | |
| Z-2292-2021 | Class II | Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm... | W. L. Gore & Associates, Inc. | DSY | |
| Z-2223-2021 | Class II | GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX | Stryker Medical | FNL | |
| Z-2222-2021 | Class II | Electric MedSurg Bed FL23 - AC-powered adjustable hospital bed with four built-in... | Stryker Medical | FNL | |
| Z-2221-2021 | Class II | CUB Pediatric Crib- intended to provide a pediatric patient support surface for medical... | Stryker Medical | FMS | |
| Z-2220-2021 | Class II | Stretcher Chair-for use in all acute care hospitals and medical outpatient services Model... | Stryker Medical | KMN | |
| Z-2219-2021 | Class II | Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest... | Stryker Medical | KMN | |
| Z-2218-2021 | Class II | Symmetry Plus Treatment Recliner - general hospital use as a convenient seating surface... | Stryker Medical | FRK | |
| Z-2217-2021 | Class II | TruRize Clinical Chair - support structure that places human occupants in upright... | Stryker Medical | INO | |
| Z-2216-2021 | Class II | S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and... | Stryker Medical | FNL | |
| Z-2215-2021 | Class II | Isolibrium Support Surface - support surface assists in the prevention and treatment of... | Stryker Medical | IKZ | |
| Z-2214-2021 | Class II | S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and... | Stryker Medical | FNL | |
| Z-2213-2021 | Class II | IsoGel Air - support surface assists in the prevention and treatment of all pressure... | Stryker Medical | IKY | |
| Z-2212-2021 | Class II | ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model... | Stryker Medical | IKY | |
| Z-2211-2021 | Class II | Proform- support surface is used to assist in the prevention and treatment of all... | Stryker Medical | IKY | |
| Z-2210-2021 | Class II | InTouch 2131-intended to support a human patient in an acute care setting, Model Number... | Stryker Medical | FNL | |
| Z-2209-2021 | Class II | Prime TC-transport chair intended for medical purposes to assist a person in performing... | Stryker Medical | INN | |
| Z-2208-2021 | Class II | Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment... | Stryker Medical | FPO | |
| Z-2207-2021 | Class II | Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term... | Stryker Medical | FPO | |
| Z-2206-2021 | Class II | Surgistool-intended to support a healthcare professional during surgical procedures Model... | Stryker Medical | FZM | |
| Z-2205-2021 | Class II | Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a... | Stryker Medical | FPO | |
| Z-2104-2021 | Class II | DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE... | Encore Medical, LP | JWH | |
| Z-2103-2021 | Class II | DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm... | Encore Medical, LP | JWH | |
| Z-1977-2021 | Class II | Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray... | Exactech, Inc. | PHX |