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-1949-2021 | Class II | Medical Action INDUSTRIES INC., Minor Procedure Tray, REF 61214 | Medical Action Industries, Inc. 306 | LRO | |
| Z-1948-2021 | Class II | Medical Action INDUSTRIES INC., General Purpose Instrument Tray, REF 61209 | Medical Action Industries, Inc. 306 | KDD | |
| Z-1947-2021 | Class II | novaplus, General Purpose Kit, Cat. No. 56603 | Medical Action Industries, Inc. 306 | KDD | |
| Z-1946-2021 | Class II | Medical Action INDUSTRIES INC., Disposable Instrument Pack Curved Hemostat, REF 56224 | Medical Action Industries, Inc. 306 | KDC | |
| Z-1945-2021 | Class II | Medical Action INDUSTRIES INC., Disposable Instrument Pack Mosquito Hemostat, REF 56220 | Medical Action Industries, Inc. 306 | KDC | |
| Z-1861-2021 | Class II | Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket... | Skytron, LLC | FQO | |
| Z-2099-2021 | Class II | NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog... | Randox Laboratories, Limited | JLH | |
| Z-2050-2021 | Class II | EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup... | implantcast GmbH | LZO | |
| Z-1903-2021 | Class II | BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture... | BioFire Diagnostics, LLC | PEN | |
| Z-1902-2021 | Class II | Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog... | Ventec Life Systems, Inc. | CBK | |
| Z-1954-2021 | Class I | LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098 | Magellan Diagnostics, Inc. | DOF | |
| Z-1953-2021 | Class I | LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004 | Magellan Diagnostics, Inc. | DOF | |
| Z-1952-2021 | Class I | LeadCare II Blood Lead Test Kit Catalog Number 70-6762 | Magellan Diagnostics, Inc. | DOF | |
| Z-1845-2021 | Class II | DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented... | Depuy Orthopaedics Inc. | JDI | |
| Z-1906-2021 | Class II | Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751 | Siemens Healthcare Diagnostics Inc. | QKO | |
| Z-1905-2021 | Class II | Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744 | Siemens Healthcare Diagnostics Inc. | QKO | |
| Z-1793-2021 | Class II | Zimmer Natural Nail- ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 130 CCD Left... | Zimmer GmbH | HSB | |
| Z-1792-2021 | Class II | Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left... | Zimmer GmbH | HSB | |
| Z-1697-2021 | Class II | Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 Lumbar... | K2M, Inc | MAX | |
| Z-1696-2021 | Class II | Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar... | K2M, Inc | MAX | |
| Z-1695-2021 | Class II | Cascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2 Lumbar... | K2M, Inc | MAX | |
| Z-1851-2021 | Class II | Corin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS, REF... | Corin Limited | MEH | |
| Z-1850-2021 | Class II | Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis... | Corin Limited | MEH | |
| Z-1865-2021 | Class II | ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve... | Johnson & Johnson Vision Care, Inc. | LPL | |
| Z-1332-2022 | Class II | Omnera 400A Digital Radiographic System | Arcoma AB | KPR | |
| Z-1331-2022 | Class II | Omnera 400T Digital Radiographic System | Arcoma AB | KPR | |
| Z-1855-2021 | Class II | WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012 | Abbott Medical | DQK | |
| Z-1854-2021 | Class II | v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model... | Abbott Medical | DQK | |
| Z-1853-2021 | Class II | v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123... | Abbott Medical | DQK | |
| Z-1978-2021 | Class II | NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96... | Neumodx Molecular, Inc. | QJR | |
| Z-1870-2021 | Class II | Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number... | Siemens Healthcare Diagnostics Inc. | JGS | |
| Z-1860-2021 | Class I | Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004... | Medtronic, Inc. | NKQ | |
| Z-1836-2021 | Class II | ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage... | Viewray, Inc. | MUJ | |
| Z-1688-2021 | Class II | VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent... | Ortho-Clinical Diagnostics, Inc. | QKP | |
| Z-0281-2022 | Class II | Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System... | Philips North America LLC | KPS | |
| Z-0280-2022 | Class II | Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System... | Philips North America LLC | KPS | |
| Z-0279-2022 | Class II | Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select... | Philips North America LLC | KPS | |
| Z-0278-2022 | Class II | Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GXL 16... | Philips North America LLC | KPS | |
| Z-0277-2022 | Class II | Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ACQSIM... | Philips North America LLC | JAK | |
| Z-1990-2021 | Class II | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306... | Philips North America LLC | JAK | |
| Z-1989-2021 | Class II | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882476... | Philips North America LLC | KPS | |
| Z-1988-2021 | Class II | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446... | Philips North America LLC | KPS | |
| Z-1987-2021 | Class II | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456... | Philips North America LLC | JAK | |
| Z-1986-2021 | Class II | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333... | Philips North America LLC | JAK | |
| Z-1985-2021 | Class II | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332... | Philips North America LLC | JAK | |
| Z-1984-2021 | Class II | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity... | Philips North America LLC | JAK | |
| Z-1983-2021 | Class II | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket... | Philips North America LLC | JAK | |
| Z-1982-2021 | Class II | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket... | Philips North America LLC | JAK | |
| Z-1981-2021 | Class II | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket... | Philips North America LLC | JAK | |
| Z-1980-2021 | Class II | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket... | Philips North America LLC | JAK |