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-1337-2019 | Class II | Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI... | Terumo Cardiovascular Systems Corporation | DTQ | |
| Z-1704-2019 | Class II | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm... | Boston Scientific Corporation | NEY | |
| Z-1703-2019 | Class II | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 19cm... | Boston Scientific Corporation | NEY | |
| Z-1702-2019 | Class II | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm... | Boston Scientific Corporation | NEY | |
| Z-1701-2019 | Class II | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Generator... | Boston Scientific Corporation | NEY | |
| Z-1700-2019 | Class II | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1)... | Boston Scientific Corporation | NEY | |
| Z-1409-2019 | Class II | Thio Med w/o Ind, w/Dex (18ml) 20/PK Product Usage: Recommended for use in qualitative... | Remel Inc | JSG | |
| Z-1408-2019 | Class II | Thio Med w/o Ind, w/Dex (18ml) 100/PK Product Usage: Recommended for use in qualitative... | Remel Inc | JSG | |
| Z-1407-2019 | Class II | Thio Med w/Dex, Hem, Vit K(10ml) 100/PK Product Usage: Recommended for use in... | Remel Inc | JSG | |
| Z-1406-2019 | Class II | Thio Med w/Dex, Hem, Vit K (10ml) 20/PK Product Usage: Recommended for use in... | Remel Inc | JSG | |
| Z-1405-2019 | Class II | Thio Med w/o Ind, w/Dex (10ml) 100/PK Product Usage: Recommended for use in qualitative... | Remel Inc | JSG | |
| Z-1404-2019 | Class II | Thio Med w/o Ind, w/Dex (10ml) 20/PK Product Usage: Recommended for use in qualitative... | Remel Inc | JSG | |
| Z-1403-2019 | Class II | Thio Med w/Dex, Hem, Vit K (9ml) 20/PK Product Usage: Recommended for use in qualitative... | Remel Inc | JSG | |
| Z-1402-2019 | Class II | Thio Med w/o Ind, w/Dex (9ml) 20/PK Product Usage: Recommended for use in qualitative... | Remel Inc | JSG | |
| Z-1401-2019 | Class II | Thio Med w/Dex, Hem, Vit K (9ml) 100/PK Product Usage: Recommended for use in... | Remel Inc | JSG | |
| Z-1400-2019 | Class II | Thio Med w/o Ind, w/Dex (9ml) 100/PK Product Usage: Recommended for use in qualitative... | Remel Inc | JSG | |
| Z-1380-2019 | Class II | Thio Med w/Dex, Hem, Vit, K (7ml) 100/PK Product Usage; Recommended for use in... | Remel Inc | JSG | |
| Z-1379-2019 | Class II | Thio Med w/Dex, Hem, Vit K (7ml) 20/PK Product Usage; Recommended for use in... | Remel Inc | JSG | |
| Z-1378-2019 | Class II | Thio Med w/Dex, Hemin, Vit K (5ml) 20/PK Product Usage: Recommended for use in... | Remel Inc | JSG | |
| Z-1377-2019 | Class II | Thio Med w/Dex, Hem, Vit K (5ml) 100/PK Product Usage; Recommended for use in... | Remel Inc | JSG | |
| Z-2398-2019 | Class II | EyeBOX Model OCL 02 | Oculogica Inc. | QEA | |
| Z-1494-2019 | Class II | Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alvarado II Base... | Zimmer Surgical SA | JEB | |
| Z-2396-2019 | Class II | AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth Electrodes (Depth... | AD-Tech Medical Instrument Corp. | GZL | |
| Z-1892-2019 | Class II | PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system. | Hitachi High-Tech America, Inc. Radiation Therapy Division | LHN | |
| Z-1709-2019 | Class II | Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes... | Abbott Medical | JJE | |
| Z-1837-2019 | Class II | CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 - Product... | Medtec LLC | IYE | |
| Z-1637-2020 | Class II | BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile... | Bard Peripheral Vascular Inc | PQK | |
| Z-1851-2019 | Class II | Freedom EVO 200 - Product Usage: It is intended for routine laboratory tasks, such as... | Tecan U.S. | JQW | |
| Z-1717-2019 | Class II | OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting... | Omni Life Science, Inc. | OLO | |
| Z-2147-2019 | Class II | Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 1-2mm 0.5g, For... | Geistlich Pharma North America, Inc | NPM | |
| Z-2146-2019 | Class II | Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.5g, For... | Geistlich Pharma North America, Inc | NPM | |
| Z-2145-2019 | Class II | Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For... | Geistlich Pharma North America, Inc | NPM | |
| Z-0194-2020 | Class II | Posey Connected Twice-As-Tough Cuffs | Tidi Products, LLC | FMQ | |
| Z-1897-2020 | Class II | da Vinci X Surgical System, IS4200 - Product Usage: The da Vinci Xi surgical system... | Intuitive Surgical, Inc. | NAY | |
| Z-1896-2020 | Class II | da Vinci Xi Surgical System, IS4000 - Product Usage: The da Vinci Xi surgical system... | Intuitive Surgical, Inc. | NAY | |
| Z-1707-2019 | Class II | NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is... | NxStage Medical Inc | KPO | |
| Z-1706-2019 | Class II | NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage PureFlow B... | NxStage Medical Inc | KPO | |
| Z-1278-2019 | Class I | Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A The Ethicon Endo-Surgery... | Ethicon Endo-Surgery Inc | GDW | |
| Z-1277-2019 | Class I | Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A The Ethicon Endo-Surgery... | Ethicon Endo-Surgery Inc | GDW | |
| Z-1276-2019 | Class I | Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon Endo-Surgery... | Ethicon Endo-Surgery Inc | GDW | |
| Z-1275-2019 | Class I | Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon Endo-Surgery... | Ethicon Endo-Surgery Inc | GDW | |
| Z-1274-2019 | Class I | Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A The Ethicon... | Ethicon Endo-Surgery Inc | GDW | |
| Z-1273-2019 | Class I | Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A The Ethicon... | Ethicon Endo-Surgery Inc | GDW | |
| Z-1272-2019 | Class I | Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A The Ethicon... | Ethicon Endo-Surgery Inc | GDW | |
| Z-1271-2019 | Class I | Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A The Ethicon... | Ethicon Endo-Surgery Inc | GDW | |
| Z-1270-2019 | Class I | Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A The Ethicon Endo-Surgery... | Ethicon Endo-Surgery Inc | GDW | |
| Z-1269-2019 | Class I | Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A The Ethicon Endo-Surgery... | Ethicon Endo-Surgery Inc | GDW | |
| Z-1268-2019 | Class I | Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A The Ethicon Endo-Surgery... | Ethicon Endo-Surgery Inc | GDW | |
| Z-1267-2019 | Class I | Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon Endo-Surgery... | Ethicon Endo-Surgery Inc | GDW | |
| Z-1808-2020 | Class II | ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument... | Uromedica Inc. | KOA |