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-0805-2022 | Class III | 20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box | CellEra, LLC | FRO | |
| Z-0804-2022 | Class III | 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box | CellEra, LLC | FRO | |
| Z-0803-2022 | Class III | 20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box | CellEra, LLC | FRO | |
| Z-0802-2022 | Class III | 20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box | CellEra, LLC | FRO | |
| Z-0801-2022 | Class III | 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box | CellEra, LLC | FRO | |
| Z-0633-2022 | Class II | Curad Reusable Gel Hot/cold Pack | MEDLINE INDUSTRIES, LP - Northfield | IME | |
| Z-0635-2022 | Class II | Acufex Access Advanced Positioning Kit - indicated for use to position and distract the... | Smith & Nephew, Inc. | KQZ | |
| Z-0550-2022 | Class I | OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1... | Abiomed, Inc. | DTZ | |
| Z-0669-2022 | Class II | RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair... | Collagen Matrix, Inc | GXQ | |
| Z-0668-2022 | Class II | DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x... | Collagen Matrix, Inc | GXQ | |
| Z-0638-2022 | Class II | OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat... | OLYMPUS Corporation of the Americas | FEB | |
| Z-0556-2022 | Class II | The EnPlace is a single use trans-vaginal pelvic floor repair system which enables... | FEMSelect, Inc. | PBQ | |
| Z-0567-2022 | Class II | THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA | Mallinckrodt Pharmaceuticals Ireland Ltd | LNR | |
| Z-0735-2022 | Class II | VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is... | Ortho-Clinical Diagnostics, Inc. | JRC | |
| Z-0542-2022 | Class II | The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a... | Dixi Medical USA | GZL | |
| Z-0541-2022 | Class II | The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a... | Dixi Medical USA | GZL | |
| Z-0540-2022 | Class II | The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a... | Dixi Medical USA | GZL | |
| Z-0539-2022 | Class II | The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a... | Dixi Medical USA | GZL | |
| Z-0538-2022 | Class II | The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a... | Dixi Medical USA | GZL | |
| Z-0537-2022 | Class II | The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a... | Dixi Medical USA | GZL | |
| Z-0536-2022 | Class II | The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a... | Dixi Medical USA | GZL | |
| Z-0535-2022 | Class II | The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a... | Dixi Medical USA | GZL | |
| Z-0534-2022 | Class II | The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a... | Dixi Medical USA | GZL | |
| Z-0441-2022 | Class II | ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-0502-2022 | Class II | greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring... | Greiner Bio-One North America, Inc. | JKA | |
| Z-0468-2022 | Class I | Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following... | Maquet Cardiovascular Us Sales, LLC | BSZ | |
| Z-0569-2022 | Class II | R82 by ETAC Push Brace for High-Low | R82 a/S | INN | |
| Z-0692-2022 | Class II | AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850 | Siemens Healthcare Diagnostics Inc. | JGJ | |
| Z-0465-2022 | Class II | Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers... | Technomed Europe | GXZ | |
| Z-0562-2022 | Class II | Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated... | Fresenius Medical Care Renal Therapies Group, LLC | QJZ | |
| Z-0490-2022 | Class II | GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100 | Depuy Orthopaedics Inc. | PHX | |
| Z-0489-2022 | Class II | GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100 | Depuy Orthopaedics Inc. | PHX | |
| Z-0488-2022 | Class II | GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100 | Depuy Orthopaedics Inc. | PHX | |
| Z-0487-2022 | Class II | GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600 | Depuy Orthopaedics Inc. | PHX | |
| Z-0486-2022 | Class II | GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100 | Depuy Orthopaedics Inc. | PHX | |
| Z-0485-2022 | Class II | GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600 | Depuy Orthopaedics Inc. | PHX | |
| Z-0484-2022 | Class II | GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100 | Depuy Orthopaedics Inc. | PHX | |
| Z-0483-2022 | Class II | GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610 | Depuy Orthopaedics Inc. | PHX | |
| Z-0451-2022 | Class I | Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT... | Medtronic, Inc. | MCW | |
| Z-0450-2022 | Class I | Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT... | Medtronic, Inc. | MCW | |
| Z-0495-2022 | Class II | LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837 | Medtronic, Inc. | GEI | |
| Z-0463-2022 | Class II | Alinity m System, Part No. 08N53-002 | Abbott Molecular, Inc. | MZP | |
| Z-0462-2022 | Class II | Alinity m System, Part No. 08N53-002 | Abbott Molecular, Inc. | MZP | |
| Z-0461-2022 | Class II | Alinity m System, Part No. 08N53-002 | Abbott Molecular, Inc. | MZP | |
| Z-0460-2022 | Class II | Alinity m System, Part No. 08N53-002 | Abbott Molecular, Inc. | MZP | |
| Z-0500-2022 | Class II | ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and... | Konica Minolta, Inc. | LLZ | |
| Z-0393-2022 | Class II | Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm. | Wright Medical Technology Inc | HRS | |
| Z-0392-2022 | Class II | Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430. | Wright Medical Technology Inc | HRS | |
| Z-0401-2022 | Class II | Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a... | Wright Medical Technology Inc | HRS | |
| Z-0680-2022 | Class I | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 | Celltrion USA Inc | QKP |